Duphacillin 150 mg Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ampicillin

Available from:

Pfizer Ltd

ATC code:

QJ01CA01

INN (International Name):

Ampicillin

Authorization status:

Expired

Summary of Product characteristics

Revised: February 2010
AN: 01781/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphacillin 150 mg Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains 150 mg Ampicillin as Ampicillin Trihydrate.
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
An off white oily suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Sheep
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of systemic infections caused by or associated with
organisms sensitive to ampicillin including:
_Bordetella bronchiseptica_
_Arcanobacterium pyogenes_
_Erysipelothrix rhusiopathiae_
_Mannheimia haemolytica_
_Pasteurella multocida_
_Salmonella _spp
_Staphylococcus _spp (non-penicillinase producing)
_Streptococcus _spp
The product will also have some effect in the treatment of enteritis
caused by _Salmonella spp. _
_ _As Salmonella species show variable
sensitivity to ampicillin, sensitivity testing is recommended prior to
treatment_._
Revised: February 2010
AN: 01781/2009
4.3
CONTRAINDICATIONS
Do not administer to penicillin sensitive animals.
Do not administer to small herbivores such as gerbils, guinea pigs,
hamsters and rabbits.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
To ensure that the product is administered by deep intramuscular
injection, a needle of the appropriate length should be used.
Although normally non-irritant, the product may occasionally cause
local reaction at the site of injection.
ii. 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-reactions
to
cephalosporins and vice versa. Allergic reactions to these substances
may occasionally be