Crystapen 5 Mega Units 3g Powder for Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benzylpenicillin Sodium

Available from:

MSD Animal Health UK Limited

ATC code:

QJ01CE01

INN (International Name):

Benzylpenicillin Sodium

Pharmaceutical form:

Powder for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

1990-12-05

Summary of Product characteristics

Revised: January 2014
AN: 01162/2013
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Crystapen 5 Mega Units 3g
Powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
PER VIAL
Benzylpenicillin
3.00g*
(as Benzylpenicillin Sodium
95.7 % w/w)
*equivalent to 5 mega-units of benzylpenicillin
EXCIPIENTS
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution for Injection.
White crystalline powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE
For the treatment and control of acute and severe systemic infections
caused by
or associated with organisms sensitive to penicillin including: _
Arcanobacterium _
_pyogenes, _
_Erysipelothrix _
_rhusiopathiae, _
_Klebsiella _
_pneumoniae, _
_Listeria _
spp_, _
_Mannheimia haemolytica, P multocida, Proteus _ spp_, Pseudomonas
aeruginosa, _
_Rhodococcus equi, Staphylococcus aureus, Streptococcus
zooepidemicus,_ some
_Salmonella_ spp.
4.3
CONTRA-INDICATIONS
Do not use in known cases of hypersensitivity to penicillins. Do not
use in small
mammals (eg. gerbils, rabbits).
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. Do not use in animals known to be
sensitive to
penicillin.
4.5
SPECIAL PRECAUTIONS FOR USE
(I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The usual aseptic precautions should be followed when administered the
product. Not for intrathecal administration.
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
Revised: January 2014
AN: 01162/2013
Page 2 of 4
local (regional, farm level) epidemiological information about
susceptibility
of the target bacteria.
(II)
SPECIAL
PRECA