15% Gamithromycin Injection
For animal use only
【Veterinary drug name】
Common name: 15% Gamithromycin Injection
Trade name: Gamilin
【Active ingredient】Gamithromycin
【Character】This product is a colorless to light yellow clear liquid.
【Pharmacology】
Pharmacodynamic Macrolide antibiotics. The semi-synthetic azalides with 15-
membered rings are mainly used for binding to bacterial ribosomal 50S subunits to
prevent the elongation of the polypeptide chain and inhibit the synthesis of bacterial
proteins. In vitro data showed that Gamithromycin acted in a bacteriostatic manner
against Haemolytic Brucellosis bovine, Pasteurella multocida, Actinobacillus
pleuropneumoniae, Pasteurella multocida and Haemophilus parasuis. The 7a position
of theGamithromycin lactone ring is an alkylated nitrogen that can be rapidly absorbed
at physiological pH and maintain long-term effects in the target animal's lung tissue.
Pharmacokinetics A single dose of bovine neck was subcutaneously injected with
6 mg/kg body weight of Gamithromycin, The maximum plasma concentration was
achieved within 30~60 minutes, and the bioavailability was >98% without gender
differences. In vitro plasma protein binding studies showed a free drug concentration
of 74%. The apparent volume of distribution is 25L/kg. The maximum concentration
of Gamithromycin is reached in the lungs in less than 24 hours, and a lung/plasma
concentration ratio of >264 indicates that Gamithromycin can be quickly absorbed into
the target tissue against respiratory diseases. Blood drug half-life is long (>2 days). The
drug is mainly excreted in the bile by its original form.
Single dose of porcine intramuscular injection of 6 mg/kg body weight of
Gamithromycin, The maximum plasma concentration was achieved within 5 to 10
minutes, nd the bioavailability was >92%.In vitro plasma protein binding assays
showed a free drug concentration of 77%. The apparent volume of distribution is
39L/kg. Gamithromycin can be quickly absorbed into target tissues to fight respiratory
diseases. The concentration of Gamithromycin in the lungs is much greater than that in
the blood. The half-life of the blood drug is long (about 4 days), and the drug is mainly
excreted in the bile by the prototype.
【Indications】
For the treatment of sensitive to Gamithromycin hemolysis Mann’s bacteria,
pasteurella multocida, Histophilus somni and mycoplasma which can cause bovine
respiratory disease (BRD). pleural pneumonia actinomycetes, pasteurella multocida
and haemophilus parasuis which can cause swine respiratory disease (SRD).
【Usage and Dosage】
Based on Gamithromycin. Subcutaneous injection: 1 dose, 6 mg per kg body
weight, for cattle (equivalent to 1 ml per 25 kg body weight). The volume of
administration at each injection site does not exceed 10 ml. Intramuscular injection: 1
dose, 6mg per kg body weight for pig, (equivalent to 1 ml per 25 kg body weight). The
volume of administration at each injection site does not exceed 5 ml.
【Adverse reaction】
Intradermal or intramuscular injections of this product may cause transient
swelling at the injection site with occasional minor pain.
【Warning/ Preventive Measures】
1. Disable animals that are allergic to macrolide antibiotics.
2. Ban with other macrolides or lincosamide antibiotics.
3. Disable cows during lactation.
4. Ban on pregnant cows with expected birth within 2 months.
5. This product has not been evaluated for safety of pregnant sows. Please use according
to the veterinarian's risk assessment.
6. Gamithromycin may be irritating to the eyes and/or skin and contact with skin and/or
eyes should be avoided. If in contact, wash immediately with water.
7. Inadvertent injection into the human body requires immediate medical attention and
provides the doctor with a label or instruction sheet.
8. Wash hands after use.
9. Keep out of reach of children.
10. Valid within 28 days after bottle opened, please abandoned expired unused parts.
【Withdrawal period】Cattle:64 days, Pigs: 27days.
【Specification】15%,20ml/vial,50ml/vial,100ml/vial.
【Packing】1 vial per box
【Storage】Sealed, Keep in a cool and dry place.
【Expiry date】36 months under the right preservation and transportation condition.
【License No.】
【Exporter】
【Manufacturer】
Enterprise Name: North China Pharmaceutical Group Corporation Veterinary Co.,
Ltd.
Address: No. 6 Huayao East Street Heping East Road, Shijiazhuang, Hebei, China