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Gamithromycin Injection
Product Name: Gamithromycin Injection
Active Ingredients Gamithromycin
Appearance The product is a clear liquid ranging from colorless to light yellow.
Pharmacological Action
Pharmacodynamics: A macrolide antibiotic. Gamithromycin is a semi-synthetic amphoteric macrolide with a 15-membered ring that binds to the 50S subunit of bacterial ribosomes, preventing the elongation of the polypeptide chain and inhibiting protein synthesis. In vitro studies show that gamithromycin has a bacteriostatic effect on Haemolyticus manis and Pasteurella multocida in cattle, as well as on Actinobacillus pleuropneumoniae, Pasteurella multocida, and Haemophilus parasuis in pigs. The 7a-methyloxime in gamithromycin’s ring is rapidly absorbed at physiological pH and maintains a prolonged action in the lung tissue of target animals.
Pharmacokinetics:
In cattle, after subcutaneous injection in the neck (6 mg/kg body weight), the maximum plasma concentration is reached within 30–60 minutes, with bioavailability >98% and no gender difference. Extra-laboratory studies on plasma protein binding show that the free drug concentration is 74%. The volume of distribution is 25 L/kg. The maximum concentration in the lungs is achieved in less than 24 hours, and a lung-to-plasma concentration ratio >264 indicates rapid absorption and action against respiratory diseases. The half-life exceeds 2 days, and the drug is mainly excreted via bile.
In pigs, after intramuscular injection (6 mg/kg body weight), the maximum plasma concentration is reached within 5–10 minutes, with bioavailability >92%. Extra-laboratory studies show that the free drug concentration is 77%. The volume of distribution is 39 L/kg. Gamithromycin is rapidly absorbed into target tissues and effectively acts against respiratory diseases. Lung concentrations of gamithromycin are significantly higher than in the blood. The half-life is about 4 days, and the drug is mainly excreted via bile.
Indications
Used for the treatment of respiratory diseases in cattle caused by Haemolyticus manis, Pasteurella multocida, and Mycoplasma, as well as respiratory diseases in pigs caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Haemophilus parasuis.
Administration and Dosage
Subcutaneous: 6 mg per 1 kg of body weight for cattle (equivalent to 1 ml per 25 kg of body weight; injection volume should not exceed 10 ml per site).
Intramuscular: 6 mg per 1 kg of body weight for pigs (equivalent to 1 ml per 25 kg of body weight; injection volume should not exceed 5 ml per site).
Side Effects
Transient swelling at the injection site may occur in cattle after subcutaneous injection or in pigs after intramuscular injection, sometimes accompanied by mild pain.
Important Notes
Contraindicated in animals allergic to macrolide antibiotics.
Do not use concurrently with other macrolide or lincosamide antibiotics.
Do not use in dairy cows.
Do not use in pregnant cows with less than 2 months to expected calving.
Safety in pregnant sows has not been established; use only under veterinary advice.
Gamithromycin may irritate eyes and/or skin. Avoid contact with skin and/or eyes. In case of accidental contact, rinse immediately with water.
In case of accidental self-injection, seek medical advice immediately and present the label or package insert.
Wash hands after use.
Keep out of reach of children.
Use within 28 days after opening the bottle; discard any unused portion.
Withdrawal Period
Cattle: 64 days
Pigs: 27 days
Specification
50 ml: 7.5 g
Packaging
50 ml/vial × 20 vials/carton
Storage
Store tightly closed.
Manufactured and packaged by
Eastern Along Pharmaceutical Co., Ltd
Address: Room 3A-9, 12 / F, Kai Ching Centre, 18 Cheung Street, Sai Ying Pun, Hong Kong
E-mali：hujiahao@ramical.com
