Ampisol 2g, powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ampicillin (as ampicillin sodium ph.eur.)

Available from:

Acravet Limited

ATC code:

QJ01CA01

INN (International Name):

Ampicillin (as ampicillin sodium ph.eur.)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ampicillin

Authorization date:

1991-12-18

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ampisol 2 g , powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains
ACTIVE SUBSTANCE:
Ampicillin (as ampicillin sodium Ph. Eur) 2g
After reconstitution with 8 ml of Water for Injection, 1 ml of
solution contains 200 mg of ampicillin.
White crystalline powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment and control of respiratory tract, alimentary tract
and urogenital tract infections.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Use of the product should be based on identification and
susceptibility testing of the target
pathogen(s). If this is not possible, therapy should be based on
epidemiological information and
knowledge of susceptibility of the target pathogens at farm level, or
at local/regional level. Use of the
product should be in accordance with official, national and regional
antimicrobial policies. Avoid
introduction of contamination during use. Use immediately after
reconstitution.
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 penicillins may lead to
cross reaction with
cephalosporins and vice versa. Allergic reaction to these substances
may occasionally be serious. Do
not handle this product if you know you are sensitised, or if you have
been advised not to work with
such preparations. Handle this product with care to avoid exposure. If
you develop symptoms
following exposure, such as a 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
may require urgent medical att