SEPTOTRYL II SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-08-2015
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Active ingredient:
TRIMETHOPRIM, SULFADIAZINE
Available from:
Vetoquinol Ireland Limited
ATC code:
QJ01EW10
INN (International Name):
TRIMETHOPRIM, SULFADIAZINE
Dosage:
100 Millilitre
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Equine - Food, Feline, Porcine
Therapeutic area:
Sulfadiazine and trimethoprim
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1994-03-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Septotryl II Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, Cattle, Pigs, Dogs, Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Septotryl II Injection is indicated for the treatment of systemic infections caused by or associated with organisms sensitive
to Trimethoprim:Sulphadiazine combination. The spectrum of activity includes both Gram positive and Gram negative
organisms including:
_Actinobacilli_
_Bordetella _spp_._
_Corynebacteria_
_Escherichia coli_
_Haemophilus _spp_._
_Klebsiella _spp_._
_Pasteurella _spp_._
_Salmonella _spp_._
_Staphylococci_
_Streptococci_
Each ml contains:
ACTIVE SUBSTANCES
Trimethoprim
40
mg
Sulfadiazine
200 mg
EXCIPIENTS
Chlorocresol
1
mg
Sodium Formaldehyde Sulfoxylate 1
mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/08/2015_
_CRN 7021600_
_page number: 1_
4.3 CONTRAINDICATIONS
Septotryl II Injection should not be given by routes other than those recommended.
Do not use in cases of hypersensitivity to the active ingredients. Do not use in animals with severe liver parenchymal
damage or blood dyscrasias.
Do not use in horses exhibiting drug induced cardiac arrhythmias, such arrhythmias may be associated with the
administration of certain anaesthetic and sedative agents.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Intravenous injections should be administered slowly over as long a period as is reasonably practical in order to a
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