Pen & Strep suspension for injection

Држава: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

DIHYDROSTREPTOMYCIN SULPHATE; PROCAINE PENICILLIN

Доступно од:

Borneosew Medical Trading (M) Sdn Bhd

INN (Међународно име):

DIHYDROSTREPTOMYCIN SULPHATE; PROCAINE PENICILLIN

Јединице у пакету:

100.00 mcg/mL; 50.00 mcg/mL

Произведен од:

Norbrook Laboratories Limited

Карактеристике производа

Page 1 of 5
PATIENT INFORMATION LEAFLET
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen & Strep Suspension for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE – EACH ML PRODUCT CONTAINS:
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)
_Streptococcus_ spp
_Salmonella_ spp
and for the control of secondary bacterial infection with sensitive
organisms in
diseases primarily associated with viral infection.
Page 2 of 5
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following
injection, inhalation, ingestion or skin contact. Hypersensitivity to
penicillins
may lead to cross-reactions to cephalosporins and vice versa. Allergic
reaction
to these substances may occasionally be serious.
1.
Do not handle this product if you know you are sensitised, or if you
have been advised not to work with such preparations.
2.
Handle this product with great care to avoid exposure taking all
recommended precautions.
3.