Denagard 200 mg/ml Solution for Injection

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Tiamulin Hydrogen Fumarate

제공처:

Elanco Europe Ltd

ATC 코드:

QJ01XQ01

INN (국제 이름):

Tiamulin Hydrogen Fumarate

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Pigs

치료 영역:

Antimicrobial

승인 상태:

Authorized

승인 날짜:

1985-07-31

제품 특성 요약

Revised: March 2022
AN: 02791/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Denagard 200 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml provides tiamulin base equivalent to 200 mg tiamulin hydrogen
fumarate.
Tiamulin hydrogen fumarate 200 mg/ml
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow oily solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Swine dysentery: For the treatment of swine dysentery caused by
_Brachyspira _
_hyodysenteriae _and complicated by _Bacteroides _spp and
_Fusobacterium _spp.
Enzootic pneumonia complex of pigs: For the treatment of enzootic
pneumonia complex, caused by _M. hyopneumoniae _and where the
secondary
bacteria are sensitive to tiamulin.
Mycoplasmal arthritis: For the treatment of arthritis caused by
_Mycoplasma _
_hyosynoviae, _to reduce lameness and restore growth performance.
4.3
CONTRAINDICATIONS
Animals should not receive products containing monensin, narasin or
salinomycin during or for at least seven days before and after
treatment with
Denagard 200 Solution for Injection. Severe growth depression or death
may
result.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For intramuscular use only in pigs.
Revised: March 2022
AN: 02791/2021
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
As Denagard 200 Solution for Injection 200 mg/ml is formulated with
sesame oil, it is important to ensure that the syringe used is dry.
The
admixture of oil and water may cause the plunger to stick.
ii.
Special precautions for the person administering the veterinary
medicinal product to animals
Avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or label to the physician.
Personal protective equipment consisting of gloves should be worn
when handling the veterinary medicinal produc