Zactran 250ml injectable solution for cattle, sheep and pigs

ZACTRAN 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Semisynthetic macrolide class antibiotic in injectable solution

Pharmaceutical form

Injectable solution (Sol.i.)

Composition per ml:

Gamithromycin 150 mg.

Pharmacological properties

Gamithromycin is an azalide, an antibiotic of the semisynthetic macrolide class, easily absorbed at physiological pH and with a long duration of action in the lungs. In vitro data show that gamithromycin acts as a bactericide. The broad spectrum of antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae, Haemophilus parasuis, and Bordetella bronchiseptica, the bacterial pathogens most commonly associated with bovine (ERB) and swine respiratory disease (PRD).

Interactions and incompatibilities

Cross-resistance with other macrolides may occur.

Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other medicinal products.

Indications

Cattle: Treatment and metaphylaxis of bovine respiratory disease (ERB) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Before metaphylactic use, the presence of the disease in the herd must be established.

Sheep: Treatment of infectious pododermatitis (pedero) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum, which requires systemic treatment.

Pigs: Treatment of swine respiratory disease (SRP) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.

Contraindications

Do not use in cases of hypersensitivity to macrolide antibiotics or to any excipient.

Do not use this veterinary medicinal product simultaneously with other macrolides or lincosamides.

Adverse reactions

Transient inflammation at the injection site was observed during clinical trials.

Bovine:

– Visible swelling at the injection site associated with occasional slight pain of a day's duration may very commonly be observed. Normally the inflammation disappears between 3 to 14 days, but in some animals it can persist up to 35 days after treatment.

Sheep and pigs:

– Mild to moderate swelling at the injection site, with occasional mild soreness lasting one day in sheep, has been commonly observed during clinical trials. These local reactions are temporary and usually resolve within 2 days (pigs) and 4 days (sheep).

Route of administration

Cattle and sheep: Subcutaneous.

Porcine: Intramuscular.

Posology

A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) in the neck (cattle and pigs) or in the anterior part of the scapular area (sheep).

Cattle and Sheep: subcutaneous injection. For the treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single injection site.

Pigs: Intramuscular injection. The injection volume should not exceed 5 ml per injection site.

To ensure the correct dose, body weight should be determined as accurately as possible to avoid underdosing.

The capsule can be safely punctured up to about 60 times. For multiple uses of the vial, an automatic dosing device is recommended to avoid excessive opening of the cap.

Special precautions

Special warnings for each target species:

Sheep: The efficacy of the antimicrobial treatment of the pedero can be reduced by other factors, such as humid environmental conditions, or an inadequate management of the farm. Foot rot treatment should therefore be instituted along with other herd management tools, such as providing a dry environment. Treatment of the benign form of foot rot with antibiotics is not considered appropriate.

Special precautions for use in animals:

The use of the veterinary medicinal product should be based on susceptibility testing and take into account local and official policies on the use of antimicrobials in farm animals.

Pregnancy and lactation:

Based on data in laboratory animals, gamithromycin has not demonstrated selective reproductive or developmental effects. The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle, sheep and pigs. Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

People with known hypersensitivity to the macrolide class should avoid all contact with the veterinary medicinal product. Gamithromycin may cause eye and/or skin irritation.

Avoid contact with skin or eyes. If eye exposure occurs, rinse immediately with clean water. If skin exposure occurs, immediately wash affected area with clean water.

In case of accidental self-injection, consult a doctor immediately and show him the package leaflet or the label.

Wash your hands after use.

Wait time

Meat:

– Cattle: 64 days.

– Sheep: 29 days.

– Pigs: 16 days.

Milk: Its use is not authorized in lactating animals whose milk is used for human consumption.

Do not use in pregnant animals intended for the production of milk for human consumption in the 2 months (cows, heifers) or 1 month (sheep) prior to the expected date of delivery.

conservation mode

This veterinary medicinal product does not require special storage conditions.

Comments

Medicine subject to a veterinary prescription.