AMOXICRID LA,

150 mg/ml,

Injection suspension for cattle, sheep, goats and pigs

Qualitative and quantitative composition:

Composition of each 1 ml:

Active substance:
Amoxicillin (as amoxicillin trihydrate) ………… 150 mg
Excipients:methyl parahydroxybenzoate …………..……1 mg
Propyl parahydroxybenzoate ……….………0.4 mg

Target animal species.
Cattle, sheep, goats and pigs.

Indications for use, specifying the target animal species.
Amoxicrid LA is used in cattle, sheep, goats and pigs for the treatment of respiratory tract infections caused by microorganisms (gram-positive and gram-negative bacteria, especially Pasteurella spp.) sensitive to amoxicillin.

Contraindications:
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in rabbits, rodents or horses.

Special precautions for use in animals.
Special precautions for use in animals.

The use of the product should be based on susceptibility testing of bacteria obtained from the animal. If this is not possible, therapy should be based on local epidemiological (regional, farm level) information on the susceptibility of the target bacteria.
Official, national and regional antimicrobial regulations should be taken into account when using the product.
Use of the product deviating from the requirements of the instructions for use may increase the risk of the development and selection of bacteria resistant to amoxicillin and may reduce the effectiveness of treatment with other penicillins due to the possibility of cross-resistance.

Special precautions to be taken by persons administering the medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to amoxicillin should avoid contact with this veterinary medicinal product.

Adverse reactions (frequency and seriousness)
In cattle, local tissue reactions may occasionally occur after injection. These reactions are transient and resolve rapidly. Adverse reactions are rare in pigs.
The frequency of adverse reactions is defined using the following convention:
 very common (more than 1 in 10 animals treated displaying adverse reaction(s));
 common (more than 1 but less than 10 animals in 100 animals treated displaying adverse reaction(s));

 uncommon (more than 1 but less than 10 animals in 1000 treated animals experienced adverse reaction(s));
 rare (more than 1 but less than 10 animals in 10,000 treated animals experienced adverse reaction(s))
 very rare (more than 1 but less than 10 animals in 10,000 treated animals experienced adverse reaction(s), including isolated cases).

Use during pregnancy, lactation or lay:
The product can be used during pregnancy and lactation.
Due to the reduced excretion of amoxicillin in milk, young animals may be given milk from treated animals during treatment with this product.

Interaction with other medicinal products and other forms of interaction:
Do not use with bacteriostatic antibiotics.

Injection doses and routes of administration of the drug
Intramuscular use.
The recommended dose is 15 mg amoxicillin/kg body weight, equivalent to 1 ml of the drug/10 kg body weight. The dose can be repeated after 48 hours.
Shake well before use.
Each subsequent injection into the animal must be carried out at a different injection site.
In cattle, the veterinary medicinal product should not be administered in an amount exceeding 20 ml at a single injection site. In pigs, the veterinary medicinal product should not be administered in an amount exceeding 6 ml at a single injection site.

The usual aseptic precautions should be observed when using the product.
In order to select the correct dosage, it is essential to determine the body weight of the animal as accurately as possible in order to avoid giving an insufficient dose.

Overdose (symptoms, emergency measures, antidotes, if necessary).
The recommended dosage should be observed.

Withdrawal period:
Pigs:
Meat and offal: 16 days.
Cattle:
Meat and offal: 14 days.
Milk: 5 lactations.
Sheep and goats:
Meat and offal: 10 days.
Milk: 4 lactations.

ATC veterinary code: QJ01CA04

Special storage precautions:
Do not store above 25°C.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing Authorisation Holder.
S.C. CRIDA PHARM S.R.L.
Str. Intrarea Vagonetului, Nr. 2, Bloc 101, Ap. 47, Parter, Sector 6, Bucharest, Romania.
Tel./Fax: +4021 4304399
E-mail: office@cridapharm.ro