Devomycin D Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Dihydrostreptomycin Sulphate, Streptomycin Sulphate

Available from:

Norbrook Laboratories Limited

ATC code:

sQJ01GA0

INN (International Name):

Dihydrostreptomycin Sulphate, Streptomycin Sulphate

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Horses, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2005-10-24

Summary of Product characteristics

Revised: April 2011
Amended pages
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Devomycin D Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains:
Streptomycin Sulfate 150 mg
Dihydrostreptomycin Sulfate 150 mg.
EXCIPIENTS:
Chlorocresol 1mg
Sodium Metabisulphate 1mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection
A clear pale yellow solution for Injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
Cattle
Sheep
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Devomycin D Injection is active against a wide range of Gram-negative
organisms
and some Gram-positive pathogens. It is indicated in the treatment of
organisms
sensitive to Streptomycin. Among the more sensitive to streptomycin
_in vitro_ are
_Actinobacillus _
_equuli_,
_A. _
_lignieresii_,
_Actinomyces _
_bovis_,
_Brucella_
spp,
_E. _
_coli_,
_Haemophilus_ spp,_ Klebsiella_ spp, _Leptospira canicola _and _L.
ictero-haemorrhagiae, _
_Pseudomonas _
_aeruginosa _
and
some
species
of
_Proteus_,
_Pasteurella _
and
_Salmonella_.
4.3
CONTRAINDICATIONS
Contraindicated in cases of known hypersensitivity to the active
ingredients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
Revised: April 2011
Amended pages
2
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of
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.
Take particular care when treating animals suffering from renal
damage.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Do not handle this product if you are sensitised (allergic) to
aminoglycoside
antibiotics.
Care should be taken to avoid accidental self-injection. In case of
accidental
injection seek medical a