Duphapen 300 mg/ml Suspension for Injection

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Procaine Benzylpenicillin

Saadav alates:

Zoetis UK Limited

ATC kood:

QJ01CE09

INN (Rahvusvaheline Nimetus):

Procaine Benzylpenicillin

Ravimvorm:

Suspension for injection

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Cattle, Pigs, Sheep

Terapeutiline ala:

Antimicrobial

Volitamisolek:

Expired

Loa andmise kuupäev:

2005-07-22

Toote omadused

Revised: April 2014
AN: 01718/2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphapen 300 mg/ml Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Procaine Penicillin 300 mg/ml
EXCIPIENT(S):
Methyl parahydroxybenzoate 1.1 mg/ml
Ethyl parahydroxybenzoate 0.23 mg/ml
Propyl parahydroxybenzoate 0.16 mg/ml
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.
_In _
_vitro_
tests
have
shown
the
following organisms to be sensitive:
_Arcanobacterium pyogenes_
_Erysipelothrix rhusiopathiae_
_Listeria _
_Mannheimia haemolytica_
_Pasteurella multocida_
_Staphylococcus_ spp. (non-penicillinase producing)
_Streptococcus_ spp.
Duphapen is recommended therefore to be effective in the treatment of
diseases
caused
by
susceptible
organisms
including:
erysipelas;
navel/joint ill; respiratory tract infections, including pneumonia and
atrophic rhinitis; listeriosis; septicaemia; urogenital tract
infections and
the control of secondary bacterial invaders in diseases of primary
viral
origin.
Revised: April 2014
AN: 01718/2013
Page 2 of 5
4.3
CONTRAINDICATIONS
Do not inject intravenously or intrathecally.
Do not use in known cases of hypersensitivity to penicillin.
Not to be used on very small herbivores such as guinea pigs, gerbils
and hamsters.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Shake the container before use.
Care should be taken not to overdose.
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 epidemiological information.
ii)
Special precautions to be taken b