Duphapen + Strep Procaine Penicillin 200 mg & Dihydrostreptomycin Sulphate 250 mg Suspension for Injection

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin

Dostopno od:

Zoetis UK Limited

Koda artikla:

QJ01RA01

INN (mednarodno ime):

Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin

Farmacevtska oblika:

Suspension for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle, Horses, Pigs, Sheep

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Expired

Datum dovoljenje:

1992-04-07

Lastnosti izdelka

Revised: April 2014
AN: 01718/2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphapen + Strep Procaine Penicillin 200 mg & Dihydrostreptomycin
Sulphate
250 mg Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Procaine Benzylpenicillin (procaine penicillin)
200 mg/ml
Dihydrostreptomycin Sulphate
250 mg/ml
EXCIPIENT(S):
Nipasept sodium
1.5 mg
Sodium formaldehyde sulphoxylate dihydrate
1.25 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
A white to off-white suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Horses
Sheep
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of systemic infections in cattle, horses, sheep and
pigs
caused by or associated with organisms sensitive to penicillin and/or
streptomycin including:
_Corynebacterium pyogenes_
_Erysipelothrix rhusiopathiae_
_Klebsiella pneumoniae_
_Listeria _spp
_Mannheimia haemolytica_
_Pasteurella multocida_
_Staphylococcus _spp (non penicillinase producing)
_Streptococcus _spp
_Salmonella _spp
And for the control of secondary bacterial infection with sensitive
organisms in
diseases primarily associated with viral infection.
Revised: April 2014
AN: 01718/2013
Page 2 of 5
4.3
CONTRAINDICATIONS
Contraindicated in known cases of hypersensitivity to penicillins.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use with care in animals known to have kidney disease or defective
renal
function.
Do not exceed the recommended dosage or duration of treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Not for intravenous or intrathecal administration.
Care should be taken not to exceed the recommended dosage.
Aminoglycosides have a narrower margin of safety than beta-lactam
antibiotics.
Use with care in animals known to have kidney disease or defective
renal
function.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animal