Hipnoton 10 mg/ml Solution for Injection for Horses and Cattle

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: VMD (Veterinary Medicines Directorate)

Ակտիվ բաղադրիչ:

Detomidine Hydrochloride

Հասանելի է:

Vetpharma Animal Health, S.L

INN (Միջազգային անվանումը):

Detomidine Hydrochloride

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

POM-V - Prescription Only Medicine – Veterinarian

Թերապեւտիկ խումբ:

Cattle, Horses

Թերապեւտիկ տարածք:

Neurological Agent sedative

Լիազորման կարգավիճակը:

Authorized

Հաստատման ամսաթիվը:

2011-11-01

Ապրանքի հատկությունները

Revised: March 2018
AN: 02138/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hipnoton 10 mg/ml Solution for injection for horses and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Detomidine ...................................................8.36
mg
(as detomidine hydrochloride 10.00 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) ............1.0
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Horses and cattle
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the sedation and slight analgesia of horses and cattle, to
facilitate
physical examinations and treatments, such as minor surgical
interventions.
Detomidine can be used for:
-
Examinations (e.g. endoscopy, rectal and gynaecological examinations,
radiographs ).
-
Minor surgical procedures (e.g. treatment of wounds, dental treatment,
tendon treatment, excision of skin tumours, teat treatment).
-
Before treatment and medication (e.g. stomach tube, horse shoeing).
For premedication prior to the administration of injectable or
inhalational
anaesthesia. See section 4.5 before use.
4.3.
CONTRAINDICATIONS
Do not use in animals with cardiac abnormalities or respiratory
disease.
Do not use in animals with liver insufficiency or renal failure.
Revised: March 2018
AN: 02138/2017
Page 2 of 6
Do
not
use
in
animals
with
general
health
problems
(e.g.
dehydrated
animals).
Do not use in combination with butorphanol in horses suffering from
colic.
Do not use in cases of hypersensitivity to the active substance or to
any of
the excipients.
See also sections 4.7 and 4.8.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
To avoid ruminal bloat and aspiration of feed or saliva, cattle should
be
maintained in sternal recumbency during and following treatment and
the
head an