Chan Pen Strep Suspension for Injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Procaine benzylpenicillin; Dihydrostreptomycin sulphate

متاح من:

Chanelle Pharmaceuticals Manufacturing Limited

ATC رمز:

QJ01RA01

INN (الاسم الدولي):

Procaine benzylpenicillin; Dihydrostreptomycin sulphate

جرعة:

200, 200 milligram(s)/millilitre

الشكل الصيدلاني:

Suspension for injection

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجموعة العلاجية:

Cattle, Pigs, Sheep

المجال العلاجي:

penicillins, combinations with other antibacterials

الخصائص العلاجية:

Antibacterial

الوضع إذن:

Authorised

تاريخ الترخيص:

2000-08-18

خصائص المنتج

Health Products Regulatory Authority
06 June 2018
CRN000XW4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Chan Pen Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Procaine Benzylpenicillin
200 mg
Dihydrostreptomycin Sulphate (as dihydrostreptomycin sulphate)
200 mg
EXCIPIENT
Sodium formaldehyde sulfoxylate
0.432 mg
Methyl Parahydroxybenzoate
1 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by bacteria sensitive to
penicillin and
dihydrostreptomycin in cattle, sheep and pigs.
4.3 CONTRAINDICATIONS
Not to be administered to animals known to be sensitive to penicillin.
Not to be used when it is known that penicillinase-producing
staphylococcus organisms are
present.
Health Products Regulatory Authority
06 June 2018
CRN000XW4
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs administration of products
containing procaine
penicillin may cause a transient pyrexia, vomiting, shivering,
listlessness and incoordinations.
In pregnant sows and gilts a vulval discharge which could be
associated with abortion has
been reported.
The maximum dose volume recommended at any one site for cattle is 20
ml.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated from the
animal. If this is not possible, therapy should be based on local
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Whenever possible the product should only be used on the basis on
susceptibility testing.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Penicillin and cephalosporins may cause hypersensitivity (