NAM PHUC THINH TRADING CO., LTD

CLOXAMED DC FORTE

Intramammary suspension

Composition: 1 syringe of 8 g suspension contains:

Cloxacillin sodium 1 H2O              200 mg

Cloxacillinbenzathine (2:1) 800 mg;

Excipient q.s8 g.

Pharmaceutical form:Intramammary white oily homogeneous suspension.

Target species: Dry cow

Indications for use:

For the treatment and prevention of intramammary infections at the beginning of dry period caused by cloxacillin-sensitive Streptococcus spp. and Staphylococcus spp. (including β-lactamase producing strains).

For the prevention of intramammary infections at the beginning of the dry period caused by cloxacillin-sensitive Arcanobacteriumpyogenes.

Amounts to be administered and administration route:

For intramammary administration.Single administration at the moment of drying off.

The content of one syringe should be infused into each quarter via the teat canal immediately after the final milking of lactation. Before infusion, the teats should be thoroughly cleaned and disinfected and care should be taken to avoid contamination of the injector nozzle. All four quarters have to be treated.

After application in the quarter, do not knead the drug upwards (risk of plugs).

Only to be used if the dry period is not shorter than 35 days.

Shake well before use.

Contraindications: Do not use in animals with known hypersensitivity to penicillins and cephalosporins. Do not use in case of resistance to isoxazolylpenicillins and cephalosporins. Do not use in lactating cows.

Adverse reactions (frequency and seriousness):Allergic reactions can occur. Adrenaline and glucocorticoids intravenously are indicated in case of anaphylaxis; antihistamines and/or glucocorticoids are indicated in case of allergic skin reactions.

Overdose (symptoms, emergency procedures, antidotes): After overdose, allergic symptoms, central nervous excitation and cramps could occur. Treatment should be discontinued immediately, and symptomatic treatment should be administered. For cramps: administer barbiturates.

Withdrawal period:

Cattle: meat and offal, milk:

1. Dry cows treated earlier than 35 days before parturition: until 5^th day (included) after the beginning of lactation.
2. Dry cows treated within 35 days before parturition or animals calving before the expected date: 40 days.

Special precautions for use:

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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. People with known hypersensitivity to penicillins or cephalosporins should avoid contact with the veterinary medicinal product.

Interaction with other medicinal products and other forms of interaction: Do not mix with bacteriostatic antimicrobials due to their potential antagonism. The combination with ampicillin will have synergistic effects.

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

Storage conditions: Do not store above 25⁰C.

Shelf-life: 2 years from the manufacturing date

Presentations: syringe 4 g (Boxes 4, 24 and 240 syringes)

FOR VETERINARY USE ONLY

Keep out of the reach of children

aniMedica GmbH

a LIVISTO company

ImSüdfeld 9, D-48308

Senden-Bösensell, Germany