Pen & Strep Suspension for Injection

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin

זמין מ:

Norbrook Laboratories Limited

קוד ATC:

QJ01RA01

INN (שם בינלאומי):

Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cattle, Horses, Pigs, Sheep

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

1991-03-12

מאפייני מוצר

Amended Pages: September 2022
AN: 01906/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen & Strep Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE_
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)
Amended Pages: September 2022
AN: 01906/2021
Page 2 of 6
_Streptococcus_ spp
_Salmonella_ spp
and for the control of secondary bacterial infection with sensitive
organisms in
diseases primarily associated with viral infection.
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 medic