Amoxycare La Suspension For Injection 15% W/V
Revised October 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Amoxycare LA Suspension for Injection 15% w/v
2. Qualitative and quantitative composition
Each ml contains
Active Substance(s) mg
(as Amoxicillin Trihydrate) 172.1
Butylated Hydroxytoluene 0.08 (as antioxidant)
Butylated Hydroxyanisole 0.08 (as antioxidant)
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Suspension for Injection
An off-white suspension
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
In vitroamoxicillin is effective against a wide range of Gram-positive and Gram-negative bacteria which include:
Not effective against beta-lactamase producing organisms.
Amoxycare LA Injection is suitable for the control of infections due to susceptible micro-organisms in cattle, sheep, pigs, dogs and cats where a single injection giving prolonged activity is required. It may also protect from secondary bacterial invasion due to sensitive organisms in cases where bacteria are not the initial cause of the disease.
Indications include infections of:
(a) Alimentary tract
(b) Respiratory tract
(c) Skin and soft tissue
(d) Urogenital tract and,
(e) In prevention of post-operative infection (treat before surgery).
This product should not be administered to rabbits, hamsters, gerbils or guinea pigs.
Not for use in known cases of hypersensitivity to penicillins or cephalosporins.
4.4 Special Warnings for each target species
No special warnings.
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 epidemiological information.
Shake well before use. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry sterile needle and syringe.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgentmedical attention.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Occasional local tissue reaction may occur with use of Amoxycare LA.
4.7 Use during pregnancy, lactation or lay
Amoxycare LA Injection can be safely administered during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Cattle, sheep and pigs - By intramuscular injection only.
Dogs and cats - By subcutaneous or intramuscular injection.
The recommended dosage rate is 15 mg per kg bodyweight, repeatable if necessary after 48 hours. Massage the injection site.
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
A separate injection site should be used for each administration.
Dosage volume (ml)
Dose volume is equivalent to 1 ml per 10 kg bodyweight. If dose volume exceeds 20 ml, it should be divided and injected into two sites. As with other injectable preparations normal aseptic precautions should be observed.
An appropriate graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Meat: 23 days
Milk: 84 hours
Meat: 16 days
Milk: contraindicated for use in sheep producing milk for human consumption.
Meat: 16 days
5. pharmacological properties
Pharmacotherapeutic group: Antibiotic
ATC Vet Code: QJ01CA04
Amoxicillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxicillin has a unique mode of action which directly and irreversibly disrupts existing cell wall peptidoglycan rather than newly forming peptidoglycan of the divisory septal wall as with other members of the penicillin family.
6. Pharmaceutical particulars
6.1 List of excipients
Propylene Glycol Dicaprylocaprate
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25ºC. Protect from light.
Following withdrawal of the first dose use the product within 28 days. Discard unused material.
Nature and composition of immediate packaging
Amoxycare LA Suspension for Injection 15% w/v is supplied in:
- 50 ml and 100 ml clear glass type II vials sealed with nitrile bungs and aluminium overseals.
- 50 ml, 100 ml, 250 ml and 500ml clear polyethylene terephthalate (PET) plastic vials sealed with nitrile bungs and aluminium overseals.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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