Instruction for use of Amoxygard

I. General information

1. Tradename of the veterinary medicinal product: Amoxygard.

International nonproprietary name: amoxicillin, clavulanic acid.

2. Pharmaceutical form: suspension for injections.

1 ml of Amoxygard contains 140 mg of amoxicillin (in form of amoxicillin trihydrate) and 35 mg of clavulanic acid (in form of potassium clavulanate) as active substances, and excipients: buthylhydroxytoluene - 2 mg and propylene glycol dicaprylate/dicaprate – up to 1 ml.

3.  Amoxygard is a suspension from white to yellow color.

During the storage exfoliation is possible, which disappears after shaking.

Shelf-life of the medicinal product under the specified conditions is 2 years from the date of manufacture, after first opening – 28 days.

The use of the drug Amoxygard after the expiration date is prohibited.

4.  The drug is available in 100 ml glass vials, sealed with rubber stoppers and rolled with aluminum caps with first opening control clips.

5.  The veterinary medicinal product in sealed original package, separately from food and feed, in a dry place, protected from direct sunlight, storage temperature range: 5 °C to 25 °C.

6.  Amoxygard should be kept out of reach of children.

7. Unused drug should be disposed of in accordance with the applicable legislation.

8. The veterinary drug Amoxygard is available without veterinary prescription.

II. Сomposition

9.    Amoxygard is a combined antibacterial drug.

10.  The drug has a broad spectrum of bactericidal activity against most gram-positive and gram-negative bacteria, including strains producing β-lactamase: Staphylococci, Streptococci, Corynebacteria, Clostridia, Bacillus antracis, Actinomyces bovis, Peptostrepto-coccus spp., Escherichia coli, Salmonellae, Bordetella bronchiseptica, Campilobacter spp., Klebsiellae, Proteus spp., Pasteurellae, Fusobacterium necrophorum, Bacteroides, Haemophilus spp., Moraxella spp., Actinobacillus pleuropneumoniae and Actinobacillus ligneresi.

Resistance to β-lactam antimicrobial drugs, is usually conditioned by the ability of microorganisms to produce β-lactamase - enzyme that destroys the β-lactam ring of antibiotic before it can effect on the bacteria. Clavulanic acid, as a part of Amoxygard, inactivates the β-lactamase and thereby restores sensitivity of bacteria to the bactericidal action of amoxicillin at concentrations that are easily reached in animal tissues after a drug administration.

By the degree of its effect on the body, Ceftonit is classified as a low-risk substance (IV substance hazard category according to the GOST 12.1.007-76). In recommended doses, Amoxygard is well tolerated by animals, has no local irritant and sensitizing action.

III. Pharmacological properties

9.  Amoxygard is administered to cattle for the treatment of respiratory diseases of bacterial etiology, obstetric-gynecological diseases - metritis, mastitis, surgical diseases, including soft tissue infections (such as abscesses, phlegmon, etc.);

to swine - for the treatment of bacterial respiratory infections, colibacillosis, postpartum infections in sows (metritis, mastitis, agalactia);

to dogs and cats - for the treatment of respiratory diseases, urological infections, diseases of the skin and soft tissues (abscesses, pyoderma, inflammation of paraanal glands, gingivitis, etc.).

10.  Contraindications include individual sensitivity of animals to β-lactam antibiotics. At the development of allergic reactions, the drug administration should be cancelled and antihistamines should be prescribed.

11. Amoxygard is administered to animals in a dose of 1 ml per 20 kg of animal body weight. The drug is administered once a day, a duration of treatment course is usually 3 to 5 days. Before each use, a bottle of Amoxygard should be shaken thoroughly to obtain a homogeneous suspension. To dogs and cats drug is administered intramuscularly or subcutaneously, cattle and swine - only intramuscularly. The injection site after administration is recommended to massage. For administration are used only dry syringe and needle.

12. Symptoms of overdose of the drug are not established.

13.  No specific actions were reported at the first use and discontinuance of the drug.

14.  Amoxygard is allowed for administration to lactating animals. The drug should be administered to pregnant and young animals with caution, under the supervision of a veterinarian.

15.  Avoid missing prescribed dose administration as this may reduce treatment effectiveness. When a dose is missed, continue to administer the product in the same dose and according to the same schedule. It should not be given a double dose to compensate the missed.

16.  No adverse reactions were observed at the administration of Amoxygard if administered subject to the instructions for use.

17. Mixing Amoxygard with other drugs in the same syringe is prohibited.

18.  The slaughter of cattle for meat is permitted no earlier than 42 days, swine – 31 days after the last administration of Amoxygard. If the animals must be slaughtered earlier, their meat can be used to feed fur-bearing animals.

The milk obtained from animals while they are being treated with Amoxygard may be used for human consumption no earlier than 108 hours after the last administration.

 

IV. Administration procedure

21. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Amoxygard.

22. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.

If product accidentally comes in contact with mucous membranes, flush them with water. In the case of allergic reactions or accidental ingestion of the product, you should contact your medical facility (you should take the instructions for use of the product or the product label with you).

23. Use of the empty vials of Amoxygard for domestic purposes is prohibited; they must be disposed of along with household waste.