Description
COMPOSITION:
Active ingredient: Tylosin Tartrate equivalent to Tylosin, 200mg/ml, w/v.
Excipients: Propylene Glycol, Water for Injections.
DESCRIPTION:
Solution for injection.
A pale yellow to amber-coloured solution.
PHARMACOLOGICAL ACTIONS:
Tylosin is a 16-membered macrolide approved for therapy of a variety of infections in cattle, calves, sheep, goats, dogs and cats. Like other macrolide antibiotics, tylosin inhibits bacteria by binding to the 50S ribosome and inhibiting protein synthesis. Spectrum of activity is limited primarily to gram-positive aerobic bacteria. Clostridium and Campylobacter are usually sensitive. The spectrum also includes the bacteria that cause BRD. Escherichia coli and Salmonella are resistant.
TARGET SPECIES:
Cattle, calves, sheep, goats, dogs and cats.
INDICATIONS:
Tylosin injection has been successfully used in respiratory and genito-urinary tract infections, otitis, cellulitis and secondary bacterial conditions associated with viral disease or post-operative infections. Specific disease entities treated successfully with Tylosin injection include foul in the foot, mastitis and calf pneumonia in cattle, calves,sheep and goats. In small animals, it is used for gram-positive soft tissue and skin infections. The most common use in dogs is for treatment of diarrhea, referred to as antibiotic-responsive diarrhea, that has not responded to other treatments.
ADMINISTRATION AND DOSAGE:
For intramuscular administration and recommended dose is shown below:
Cattle and calves: 4 to 10 mg per kg body weight daily (equal 2-5 ml per 100 kg body weight).
Sheep and goats: 6 to 8 mg per kg body weight daily (equal 0.3-0.4 ml per 10 kg body weight).
Dogs and cats: 8 to 10 mg per kg body weight every 12 hours (equal 0.4-0.5 ml per 10 kg body weight).
If there is no response to treatment in 3 days, diagnosis and treatment should be reassessed.
The maximum injection volume for cattle is limited to 15 ml per injection site.
To ensure the correct dosage, body weight should be determined as accurately as possible.
CONTRAINDICATIONS:
Do not administer to horses or other equines in which injection of tylosin may be fatal.
PRECAUTIONS:
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.
For administration by the intramuscular route only.
Use different injection sites for repeat injections.
Special precautions to be taken by person administering the medicinal product to animals
Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross-reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
Do not handle the product if you are allergic to ingredients in the product.
If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Keep out of the reach of children.
ADVERSE REACTIONS:
Possible adverse reactions attributed to the product when used as recommended and their frequency are in very rare cases the following have been observed:
-Swelling/inflammation at the site of injection.
-Valvular swelling in cattle.
-Anaphylactic shock and death.
DRUG INTERACTIONS:
Although other macrolides have been associated with inhibition of cytochrome P450 enzymes, no drug interactions have been reported for animals.
WITHDRAWAL PERIOD:
For meat: 28 days.
For milk: 5 days.
STORAGE:
Sealed and Store below 30°C. Protect from light.
PACKAGE:
50ml/100ml.
SHELF LIFE:
3 years.
Shelf life after opening: 28 days.
