PEN & STREP VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DIHYDROSTREPTOMYCIN SULFATE; PROCAINE BENZYLPENICILLIN

متاح من:

COMEX LTD

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

PROCAINE BENZYLPENICILLIN 200 MG/ML; DIHYDROSTREPTOMYCIN SULFATE 250 MG/ML

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

الخصائص العلاجية:

Treatment of infection caused orassociated with organisms sensitive to penicillin and/or streptomycin in cattle, horses, pigs and sheep.

تاريخ الترخيص:

2021-04-30

نشرة المعلومات

VETERINARY MEDICINE USER LEAFLET
Veterinarian Prescription Only Medicine
For Animal Use Only
1.
NAME AND FORM OF THE VETERINARY MEDICINE:
_PEN & STREP VETERINARY, SUSPENSION FOR INJECTION _
2.
ACTIVE INGREDIENTS:
Each 1 ml of the medicine contains:
_Procaine Penicillin _
_200 mg _
_ _
_Dihydrostreptomycin Sulphate _
_250 mg _
The medicine also contains the excipients:
Hydroxybenzoate Esters (as Nipasept Sodium) 1.5mg as antimicrobial
preservative.
Sodium Formaldehyde Sulphoxylate dihydrate 1.25mg as antioxidant.
For a full list of excipients, see section 13 “Further
Information”.
3.
INDICATIONS FOR USE:
Treatment of infection caused by or associated with organisms
sensitive to
penicillin and/or streptomycin in cattle, horses, pigs and sheep.
THERAPEUTIC GROUP: Antibacterials for systemic use.
4.
CONTRAINDICATIONS:
Contraindicated in known cases of hypersensitivity to penicillins.
5.
ADVERSE REACTIONS:
In rare cases, hypersensitivity reactions can occur and very rarely,
these can
be fatal.
Very rarely, in sucking and fattening pigs, administration may cause a
transient
pyrexia, vomiting, shivering, listlessness and incoordination.
A palpable but transient local reaction may occur at the site of
intramuscular
administration in horses.
Side effects can be reported to the Ministry of Health by clicking on
the link
“Reporting adverse events due to drug treatment” found on the home
page of
the Ministry of Health website (www.health.gov.il), which refers to
the online
form for reporting adverse events, or by entering the link:
https://sideeffects.health.gov.il
6.
TARGET SPECIES:
Cattle, horses, pigs, sheep.
7.
AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE:
Administer by deep intramuscular injection.
Recommended dosage rate is 8 mg/kg bodyweight procaine penicillin with
10 mg/kg bodyweight dihydrostreptomycin sulphate equivalent to 1 ml /
25 kg
bodyweight.
Treatment should be given once daily for up to 3 consecutive days.
8.
HOW TO USE THE PRODUCT:
Shake the vial before use.
The maximum dose volume administe

خصائص المنتج

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen & Strep Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCES _
Procaine Penicillin
200 mg
Dihydrostreptomycin Sulphate
250 mg
_EXCIPIENTS _
The
product
also
contains
1.5mg
Hydroxybenzoate
Esters
(as
Nipasept
Sodium)
as
antimicrobial
preservative
and
1.25mg
sodium
formaldehyde
sulphoxylate dihydrate as antioxidant.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for Injection
A white to off-white aqueous suspension for injection.
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:
_Arcanobacterium pyogenes _
_Erysipelothrix rhusiopathiae _
_Klebsiella pneumoniae _
_Listeria _spp
_Mannheimia haemolytica _
_Pasteurella multocida _
_Staphylococcus _spp (non-penicillinase producing)
Page 2 of 6
_Streptococcus _spp
_Salmonella _spp
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:
Care
should
be
taken
not
to
exceed
the
recommended
dosage.
Aminoglycosides have a narrower margin of safety than beta lactam
antibiotics.
ii.
Special precautions to be taken by the person administering the
product to the animals:
Care should be taken to avoid accidental self-injection. In the case
of
accidental self-injection, seek medical advice immediately.
Penicillins
and cephalosporins
may cause
hypersensitivity (allergy)
following injection, inhalation, ingestion or skin contact.
Hypersensitivity
to penicillins may lead to cross-reactions to cephalosporins