CRYSTAPEN 5 MEGA 95.7% W/W POWDER FOR SOLUTION FOR
Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Данни за продукта
(SPC)
10-06-2024
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Активна съставка:
BENZYLPENICILLIN
Предлага се от:
Schering Plough Limited
АТС код:
QJ01CE01
дозиране:
95.7 %w/w
Лекарствена форма:
Pdr for Soln for Injection
Терапевтична група:
Antibacterial
Терапевтична област:
Equine - Food
Дата Оторизация:
1997-10-01
Данни за продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Crystapen 5 Mega 95.7% w/w Powder for Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
A white powder for solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of systemic infections caused by or associated with organisms sensitive to penicillin
including:
Gram-positive bacteria
_Arcanobacterium pyogenes_
_Erysipelothrix rhusiopathiae_
_Listeria _spp.
_Rhodococcus equi_
_Staphylococcus aureus_
_Streptococcus zooepidemicus_
Gram-negative bacteria
_Klebsiella pneumoniae_
_Mannheimia haemolytica_
_Pasteurella multocida_
_Proteus _spp.
_Pseudomonas aeruginosa_
Some _Salmonella _spp.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to penicillins.
Each vial contains
ACTIVE SUBSTANCE
Benzylpenicillin
3g*
(as Benzylpenicillin Sodium Ph. Eur.
95.7 % w/w)
*equivalent to 5 mega-units of benzylpenicillin
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/12/2010_
_CRN 7009860_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings are considered necessary.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The usual aseptic precautions should be followed when administering the product.
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 (regional, farm level) epidemiological information about
susceptibility of the target bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL
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