Geepenil vet 300 mg/ml Powder and Solvent for Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benzylpenicillin Sodium

Available from:

Orion Corporation

ATC code:

QJ01CE01

INN (International Name):

Benzylpenicillin Sodium

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2020-10-21

Summary of Product characteristics

Issued: October 2020
AN: 01724/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Geepenil vet 300 mg/ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Powder vial contains:_
ACTIVE SUBSTANCE:
Benzylpenicillin sodium
24 g
_Solvent vial contains 64 ml of sterile water_
_Each ml of the reconstituted product contains:_
ACTIVE SUBSTANCE:
Benzylpenicillin sodium
300 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder vial: white or almost white crystalline powder
Solvent vial: clear, colourless liquid
Reconstituted solution for injection: clear, colourless liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections caused by micro-organisms sensitive to benzylpenicillin in
horse.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any
of the excipients.
Do not use this product in the treatment of diseases caused by
beta-lactamase
producing staphylococci.
Issued: October 2020
AN: 01724/2018
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Penicillins 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
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
This medicinal product must not be administered intramuscularly to
horses
because it causes local irritation.
Use of the product should be based on susceptibility testing of
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.
The usual aseptic precautions should be followed when administered the
product.
Not for intrathecal