PEN/STREP Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

זמין מ:

Chem-Pharm Limited

קוד ATC:

QJ01RA01

INN (שם בינלאומי):

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

כמות:

200,200 milligram(s)/millilitre

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cattle, Pigs, Sheep

איזור תרפויטי:

penicillins, combinations with other antibacterials

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

1997-10-01

מאפייני מוצר

ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PEN/STREP 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
incoordination.
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