Trimediazine Paste Oral Paste

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

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제품 특성 요약 제품 특성 요약 (SPC)
14-02-2023

유효 성분:

Sulfadiazine, Trimethoprim

제공처:

Vetoquinol UK Ltd

ATC 코드:

QJ01EW10

INN (International Name):

Sulfadiazine, Trimethoprim

약제 형태:

Oral paste

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Horses

치료 영역:

Antimicrobial

승인 상태:

Authorized

승인 날짜:

1993-08-04

제품 특성 요약

                                Revised: May 2018
AN: 00005/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimediazine Paste Oral Paste
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 45g syringe contains Trimethoprim 2.6g and Sulfadiazine 13.0g and
as
preservatives: Methyl hydroxybenzoate 81mg and Propyl Hydroxybenzoate
9mg.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Oral paste.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated in the treatment of bacterial infections in horses caused by
sensitive
micro-organisms including:
_Escherichia coli_
_Rhodococcus (Corynebacterium) equi_
_Staphylococcus_ spp.
_Streptococcus_ spp.
The product may be effective in alimentary tract infections including
diarrhoea;
respiratory infections including pneumonia, pleurisy and strangles;
wounds;
septicaemia and general infections
4.3
CONTRA-INDICATIONS
Do not use in known cases of hypersensitivity to the active substances
or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special precautions.
Revised: May 2018
AN: 00005/2018
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
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 about susceptibility of the
target bacteria.
Do not use the same syringe to treat more than one animal unless
horses
are running together or in direct contact with each other on the same
premises.
Not recommended in horses with known hypersensitivity, severe hepatic
dysfunction or cardiac arrhythmias.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Avoid direct contact with skin and eyes. If contact occurs, wash
affected
area with copious amounts of water.
Seek medical advice if irritation persists.
Gloves should be worn whilst handling this product
                                
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