Pen & Strep Suspension for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

Verfügbar ab:

Norbrook Laboratories (Ireland) Limited

ATC-Code:

QJ01RA01

INN (Internationale Bezeichnung):

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

Dosierung:

200, 200 milligram(s)/millilitre

Darreichungsform:

Suspension for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

penicillins, combinations with other antibacterials

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

1987-10-01

Fachinformation

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 _
_ _
_Staphylococcus_
_spp._
(non-penicillinase producing)
_Streptococcus_
_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 PRECAUTIONS FOR USE IN ANIMALS
Administer by deep intramuscular injection only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICI