AMPITRAS 20% W/V, SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
08-05-2024
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Active ingredient:
AMPICILLIN TRIHYDRATE
Available from:
Kela n.v.
ATC code:
QJ01CA01
INN (International Name):
AMPICILLIN TRIHYDRATE
Dosage:
20 %w/v
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Ampicillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1987-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ampitras 20% w/v, suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Ampicillin
200mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oily, white suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute infections of the gastrointestinal, urinary and respiratory tract; infections of the skin and soft
tissues; septicemia and polyarthritis in the new-born.
4.3 CONTRAINDICATIONS
Do not use in rabbits and other rodents.
Do not use in horses.
Do not use in animals with known hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2012_
_CRN 7012480_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Shake well before use.
Avoid the introduction of contamination before use.
Should any apparent growth or discolouration occur, the product should be discarded.
Transitory local swelling may occur. It is advisable not to inject too large a volume at the same injection site. It is advisable
to alternate injection sites for consecutive injections.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
Penicillin 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. Allergic reaction
to these substances can occasionally be serious.
1. Do not handle thi
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