Intal Spincaps may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Intal Spincaps in the following countries:
International Drug Name Search
Temporarily relieving redness, burning, and irritation caused by dry eyes. It may also be used for other conditions as determined by your doctor.
All Clear AR Drops are an eye decongestant and lubricant. It works by constricting the blood vessels in the eye and coating the eye, which relieves redness, dryness, and irritation.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with All Clear AR Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with All Clear AR Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if All Clear AR Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use All Clear AR Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use All Clear AR Drops.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; minor stinging when the medicine is dropped into the eye.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain; worsening or persistent eye irritation or redness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: All Clear AR side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. All Clear AR Drops may be harmful if swallowed, especially in children.
Store All Clear AR Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep All Clear AR Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about All Clear AR Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
The following drugs and medications are in some way related to, or used in the treatment of Osteolytic Bone Metastases of Solid Tumors. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.
Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets are a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; seizures; severe or persistent dizziness, lightheadedness, or headache; tremor.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Carbetapentane/Guaifenesin/Phenylephrine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bizarre behavior; blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; unusually fast, slow, or irregular heartbeat; vomiting.
Store Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Carbetapentane/Guaifenesin/Phenylephrine Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Nicotinell® Mint 4mg Medicated Chewing Gum
One piece of medicated chewing gum contains 4 mg nicotine (as 20 mg nicotine – polacrilin (1:4)).
For excipients, see section 6.1.
Medicated chewing gum.
Each piece of coated chewing gum is off-white in colour and rectangular in shape.
Nicotinell gum is indicated for the relief of nicotine withdrawal symptoms, as an aid to smoking cessation. Nicotinell Mint 4mg gum is for use when severe withdrawal symptoms are experienced.
Concurrent counselling/behavioural support is recommended as it is likely to increase the chances of a successful quit.
Adults and elderly
Users should stop smoking completely during treatment with Nicotinell gum.
One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 15 pieces per day.
The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.
The optimal dosage form is selected according to the following table:
|
If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.
The characteristics of chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.
Directions for use:
1. One piece of gum should be chewed until the taste becomes strong.
2. The chewing gum should be rested between the gum and cheek.
3. When the taste fades, chewing should commence again.
4. The chewing routine should be repeated for 30 minutes.
The treatment time is individual. Normally, treatment should continue for at least 3 months.
After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.
Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day. Use of nicotine products like Nicotinell gum beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the gum for longer to avoid returning to smoking. Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals.
Nicotinell gum is sugar free.
Adolescents (aged 12-18 years of age)
The above recommendation can be used for adolescents aged between 12 and 18 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the gum beyond 12 weeks.
Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum.
Hypersensitivity to nicotine or any components of the gum.
Nicotinell gum should not be used by non-smokers.
Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well established dangers of continued smoking.
Precautions: Users should stop smoking completely during therapy with Nicotinell gum. They should be informed that if they continue to smoke while using the gums they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.
Cardiovascular disease
In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke. However dependant smokers currently hospitalised as a result of a recent myocardial infarction, severe disrythmia, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicotinell gum may be considered but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
Allergic reactions
Angioedema and urticaria have been reported.
Gastro-intestinal disease
Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions. Ulcerative stomatitis have been reported.
Renal and or hepatic impairment
Should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Danger in small children
Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of with care.
Pheochromocytoma and uncontrolled hyperthyroidism
Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.
Transferred dependence
Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.
Other warnings
If denture wearers experience difficulty in chewing the gum, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Nicotinell 4mg gum contains sorbital (E420) 0.2g per gum, a source of 0.04g fructose. Calorific value 0.9 kcal/piece of gum.
Nicotinell 4mg gum contains sodium 11.52 mg per piece of gum.
No information is available on interactions between Nicotinell gum and other drugs. No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.
Pregnancy
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or still birth. Stopping smoking is the single most effective intervention for improving the health of the pregnant smoker and her baby. The earlier abstinence is achieved the better.
Ideally smoking cessation during pregnancy should be achieved without nicotine replacement therapy. For women unable to quit on their own nicotine replacement therapy may be recommended to assist a quit attempt. The risk of using nicotine replacement therapy to the foetus is lower than that expected with tobacco smoking, due to lower maximal plasma concentrations and no additional exposure to polycyclic hydrocarbons and carbon monoxide.
However as nicotine passes to the foetus affecting breathing movements and has a dose-dependant effect on placental/foetal circulation, the decision to use nicotine replacement therapy should be made on a risk-benefit assessment as early on in pregnancy as possible with the aim of discontinuing use after 2-3 months.
Intermittent dose products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed to avoid exposure overnight when the foetus would not normally be subjected to smoke derived nicotine.
Lactation
Nicotine from smoking and nicotine replacement therapy is found in breast milk. However the amounts of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.
Using intermittent dose products, compared to patches, may minimize the amount of nicotine in the breast milk as the time between administrations of nicotine replacement therapy and feeding can be more easily prolonged.
Not applicable.
Some symptoms such as dizziness, headache and sleep disturbances may be related to the withdrawal of nicotine associated with stopping smoking.
In principle, Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking) and these are mainly dose dependant. At recommended doses Nicotinell gum has not been found to cause any serious adverse effects. Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Most of the side effects which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy.
Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the start of the treatment.
The gum may stick to and in rare cases damage dentures and dental appliances.
Common (> 1/100).
Nervous system disorders: headache, dizziness
Gastrointestinal disorders: hiccups, gastric symptoms e.g. nausea, vomiting, indigestion, heartburn, increased salivation, irritation or sore mouth or throat.
Musculoskeletal, connective and bone disorders: jaw muscle ache.
Uncommon (>1/1,000, <1/100)
Cardiac disorders: palpitations
Skin and subcutaneous tissue disorders: erythema, urticaria
Rare (<1/1,000)
Cardiac disorders: cardiac arrhythmias (e.g. atrial fibrillation)
Immune system disorders: hypersensitivity, angioneurotic oedema and anaphylactic reactions.
In overdose, symptoms corresponding to heavy smoking may be seen, however the toxicity of nicotine cannot be directly compared with that of smoking, because tobacco smoke contains additional toxic substances (eg. carbon monoxide and tar).
Overdose with Nicotinell gum may only occur if many pieces are chewed simultaneously. Nicotine toxicity after ingestion will most likely be minimized as a result of early nausea and vomiting that occur following excessive nicotine exposure. Risk of poisoning by swallowing the gum is small. Since the release of nicotine from the gum is slow, very little nicotine is absorbed from the stomach and intestine, and if any is, it will be inactivated in the liver.
Chronic smokers can tolerate doses of nicotine that, in a non-smoker, would be more toxic, because of the development of tolerance.
Symptoms
The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40-60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of overdose
Following overdose, symptoms may be rapid particularly in children. All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.
ATC Code: N07B A01
Pharmacotherapeutic group: Drugs used in nicotine dependence
Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor agonist in the peripheral and central nervous systems and has pronounced CNS and cardiovascular effects. On consumption of tobacco products, nicotine has proven to be addictive, resulting in craving and other withdrawal symptoms when administration is stopped. This craving and these withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, concentration difficulties agitation and increased appetite or weight gain. The gum replaces part of the nicotine that would have been administrated via tobacco and reduces the intensity of the withdrawal symptoms and smoking urge.
When the gum is chewed, nicotine is steadily released into the mouth and is rapidly absorbed through the buccal mucosa. A proportion, by the swallowing of nicotine containing saliva, reaches the stomach and intestine where it is inactivated.
The nicotine peak plasma mean concentration after a single dose of the 4 mg coated gum is approximately 9.3 nanograms per ml (after approximately 60 minutes) (average plasma concentration of nicotine when smoking a cigarette is 15-30 nanograms per ml).
Nicotine is eliminated mainly via hepatic metabolism; small amounts of nicotine are eliminated in unchanged form via the kidneys. The plasma half-life is approximately three hours. Nicotine crosses the blood-brain barrier, the placenta and is detectable in breast milk.
No definite conclusion can be drawn on the genotoxic activity of nicotine in vitro. Nicotine was negative in in-vivo tests.
Animal experiments have shown that nicotine induces post-implantation loss and reduces the growth of foetuses.
The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine.
Gum base (containing butylhydroxytoluene)
Calcium carbonate
Sorbitol (E420)
Sodium carbonate anhydrous
Sodium hydrogen carbonate
Polacrilin
Glycerol
Purified water
Levomenthol
Peppermint oil
Eucalyptus oil
Saccharin
Sodium saccharin
Acesulfame potassium
Xylitol
Mannitol (E421)
Gelatin
Titanium dioxide (E171)
Carnauba wax
Talc.
Not applicable.
2 years.
Do not store above 25oC.
The chewing-gum is packed in PVC/PVdC/aluminium blisters each containing either 2 or 12 pieces of gum. The blisters are packed in boxes containing 2, 12, 24, 36, 48, 60, 72, 96 108, 120 and 204 pieces of gum.
Not all pack sizes may be marketed.
No special requirements.
Novartis Consumer Health UK Ltd
Trading as Novartis Consumer Health
Wimblehurst Road,
Horsham,
West Sussex RH12 5AB
PL 00030/0428
8 December 2006
12 June 2008
Legal category: GSL
Paracetamol Capsules 500 mg
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
This medicine contains Paracetamol which belongs to a group of medicines called analgesics and antipyretics to relieve pain and reduce fever.
It can be used to relieve headaches, migraine, rheumatic or muscular pain, back pain, neuralgia, toothache, period pain and the symptoms of colds and flu.
This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
You can take this medicine if you are breastfeeding.
This medicine contains paracetamol. Do not take with any other paracetamol-containing products
Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
Check the foil is not broken before use. If it is, do not take that capsule.
Adults and children of 12 years and over
Take one or two capsules
Three or four times a day, if you need to.
Don't take more than 8 capsules in any 24 hours.
Don't take more often than every 4 hours.
Swallow each capsule whole with water.
Do not give to children under 12 years.
Do not take more than the amount recommended above.
If symptoms do not go away within 3 days talk to your doctor. If symptoms persist talk to your doctor.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
Most people will not have problems, but some may get some of these:
If you get any of these serious side effects, stop taking the capsules.
These other effects are less serious.
If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.
Do not store above 30°C.
Store in the original package.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
Each capsule contains Paracetamol 500 mg, which is the active ingredient.
As well as the active ingredient, the capsules also contain sodium starch glycolate, magnesium stearate, sodium laurilsulfate. The capsule shell contains gelatin, indigo carmine (E132), titanium dioxide (E171).
The pack contains 16 or 32 capsules with a blue cap and white body.
Manufactured for
by
Leaflet prepared December 2007
If you would like any further information about this medicine, please contact
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Paracetamol Capsules 500 mg
Reference number: 00014/0442
This is a service provided by the Royal National Institute of the Blind.
BTC23830 vC 21/08/08
For Use In Cattle and Swine Only
ELANCO* AH 0205-82X
An Antibiotic
Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes. In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.
ADMINISTRATION AND DOSAGE: Tylan 50 Injection is administered intramuscularly.
BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 6.25 pounds). Treatment should be continued 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site.
This formulation is recommended for use in calves weighing less than 200 pounds.
SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 12.5 pounds) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site.
Read accompanying directions fully before use.
CAUTION: Do not mix Tylan 50 Injection with other injectable solutions as this may cause a precipitation of the active ingredients. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.
| PRECAUTION: Adverse reactions, including shock and death may result from overdosage in baby pigs. Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL) unless the syringe is capable of accurately delivering 0.1 mL. |
If tylosin medicated drinking water is used as a follow-up treatment for swine dysentery the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.
NOT FOR HUMAN USE
WARNING: Discontinue use in cattle 21 days before slaughter. Discontinue use in swine 14 days before slaughter.
Do not use in lactating dairy cattle.
A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
Store at 72°F (22°C) or below.
*Elanco®, Tylan® and the diagonal color bar are trademarks of Eli Lilly and Company.
Restricted Drug (California) - Use Only as Directed.
NADA 12-965, Approved by FDA
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Manufactured for: Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, USA
Principal Display Panel – 100 mL Bottle Label
ELANCO* AH 0205-82X
Tylan® 50
Tylosin
Injection
50 mg per mL
For Use In Cattle and Swine Only
100 mL
An Antibiotic
Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes. In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.
ADMINISTRATION AND DOSAGE: Tylan 50 Injection is administered intramuscularly.
Manufactured for: Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, USA
YL9500DEAMB (V01-08-2009)
Principal Display Panel – 100 mL Carton Label
ELANCO* AH 0205-82X
Tylan® 50
Tylosin
Injection
50 mg per mL
For Use In Cattle and Swine Only
100 mL
The Original Tylan 50
An Antibiotic For
Cattle
Swine
100 mL
| Tylan 50 tylosin injection, solution | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA12965 | 06/03/2010 | |
| Labeler - Elanco Animal Health Co (807447169) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Norbrook Laboratories Limited | 232880554 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Evonik Degussa Corporation | 130890994 | API MANUFACTURE | |
Vitazol™ Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.
Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.
Teratogenic effects: Pregnancy category B
There are no adequate and well-controlled studies with the use of Metronidazole Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.
After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Apply and rub in a thin layer of Vitazol™ Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing.
Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Vitazol™ Metronidazole Topical Cream.
Vitazol™ Metronidazole Topical Cream, 0.75% is supplied in a 60 g tube - NDC 49908-100-60.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080
Distributed by:
Rochester Pharmaceuticals
Rochester, NY 14625
FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE. RX only NDC 49908-100-60
VitazolTM Metronidazole Topical Cream 0.75% NET WT 60 g
Each gram contains - Active: metronidazole 0.75% (7.5 mg). Inactive: emulsifying wax, sorbitol solution, glycerin, Isopropyl plamitate,benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water.
Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
See end panel for lot no. and expiration date.
Distributed by: Rochester Pharmaceuticals
Rochester, NY 14625
Manufactured by: G&W Laboratories, Inc.
South Plainfield, NJ 07080
| Vitazol metronidazole topical cream 0.75% cream | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA123456 | 01/01/2010 | |
| Labeler - Rochester Pharmaceuticals (134473771) |
Removing dead tissue and thinning the pus in lesions such as ulcers, burns, wounds, and carbuncles.
Accuzyme Ointment is a debriding agent. It works by helping the breakdown of dead skin and pus, which helps improve the recovery time of open wounds.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Accuzyme Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Accuzyme Ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Accuzyme Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Accuzyme Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Accuzyme Ointment.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Mild skin irritation; temporary burning sensation.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Accuzyme side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Accuzyme Ointment in a cool place, between 46 and 59 degrees F (8 and 15 degrees C). Do not refrigerate. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Accuzyme Ointment out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Accuzyme Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Treating mild to moderate infections caused by certain bacteria.
Vantin Suspension is a cephalosporin antibiotic. It works by interfering with the formation of the bacteria's cell wall so that the wall ruptures, resulting in the death of the bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Vantin Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vantin Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Vantin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Vantin Suspension.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; loose stools; nausea; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; seizures; severe diarrhea; skin rash; stomach pain/cramps; vaginal irritation or discharge.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Vantin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include abdominal pain; diarrhea; headache; nausea; seizures; vomiting.
Store Vantin Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). The mixed solution may be used for up to 14 days. Keep the container tightly closed. Throw away any unused portion after 14 days. Keep Vantin Suspension out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Vantin Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
floo-TIK-a-sone PROE-pee-oh-nate
In the U.S.
Available Dosage Forms:
Therapeutic Class: Corticosteroid, Intermediate
Pharmacologic Class: Fluticasone
Fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). Corticosteroids belong to the family of medicines called steroids. Fluticasone is sprayed into the nose to help relieve the stuffy or runny nose, irritation, sneezing, and discomfort of hay fever, other nasal allergies, and these symptoms when not caused by allergies.
fluticasone propionate is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone propionate, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone propionate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
There is no specific information comparing the use of nasal fluticasone in children up to 4 years of age with use in other age groups. Corticosteroids taken by mouth or injection have been shown to slow growth in children and cause reduced adrenal gland function. Before nasal fluticasone is given to a child, you and the child's doctor should talk about the good fluticasone propionate will do as well as the risks of using it.
Although there is no specific information comparing use of nasal corticosteroids in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone propionate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using fluticasone propionate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of fluticasone propionate. Make sure you tell your doctor if you have any other medical problems, especially:
fluticasone propionate usually comes with patient directions. Read them carefully before using the medicine.
Before using fluticasone propionate, prime the pump on the medicine bottle and clear the nasal passages by blowing your nose. Then, insert the nosepiece into the nostril, and with the head tilted slightly forward, spray while breathing in gently through the nostril.
Avoid spraying in the eyes.
In order for fluticasone propionate to help you, it must be used regularly as ordered by your doctor. fluticasone propionate usually begins to work in about 12 hours, but several days may pass before you feel its full effects.
Use fluticasone propionate only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of absorption through the lining of the nose and the chance of unwanted effects.
The dose of fluticasone propionate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fluticasone propionate. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of fluticasone propionate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If you will be using fluticasone propionate for more than a few weeks, your doctor should check your progress at regular visits.
Check with your doctor:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
