Pen & Strep Suspension for Injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Procaine benzylpenicillin; Dihydrostreptomycin

Disponible des:

Norbrook Laboratories Limited

Codi ATC:

QJ01RA01

Designació comuna internacional (DCI):

Procaine benzylpenicillin; Dihydrostreptomycin

Dosis:

200, 200 milligram(s)/millilitre

formulario farmacéutico:

Suspension for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

penicillins, combinations with other antibacterials

Estat d'Autorització:

Authorised

Data d'autorització:

1987-10-01

Fitxa tècnica

Health Products Regulatory Authority
15 November 2018
CRN008Q6S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen & Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances
Procaine Benzylpenicillin
200
mg
Dihydrostreptomycin Sulphate
equivalent to Dihydrostreptomycin
200
mg
Excipients
Methyl, ethyl, and propyl parahydroxybenzoates
as sodium salts (as preservative)
1.5
mg
Sodium formaldehyde sulfoxylate (as antioxidant)
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, 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 penicillin and/or streptomycin including:
_Corynebacterium pyogenes_
_Erysipelothrix rhusiopathiae_
_Klebsiella pneumoniae_
_Listeria spp_
_Pasteurella haemolytica_
_Pasteurella multocida_
Health Products Regulatory Authority
15 November 2018
CRN008Q6S
Page 2 of 5
_Staphylococcus spp_. (non-penicillinase producing)
_Streptococccus spp._
Pen & Strep will therefore be effective in the treatment of infections
caused by
susceptible organisms including: erysipelas; navel/joint ill;
respiratory tract infections,
including pneumonia and atrophic rhinitis; listeriosis, meningitis;
septicaemia;
toxaemia associated with mastitis; urogenital tract infections;
enteritis and the control
of secondary bacterial invaders in diseases of primary viral origin.
4.3 CONTRAINDICATIONS
Not for intravenous administration.
Not for use in sheep producing milk for human consumption.
Contra-indicated in known cases of hypersensitivity to penicillins.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs, administration of Pen &
Strep may cause
transient pyrexia, vomiting, shivering, listlessness and
inco-ordination.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL