Domitor 1 mg/ml Solution for Injection

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Medetomidine Hydrochloride

可用日期:

Orion Corporation

ATC代码:

QN05CM91

INN（国际名称）:

Medetomidine Hydrochloride

药物剂型:

Solution for injection

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Cats, Dogs

治疗领域:

Neurological Agent sedative

授权状态:

Authorized

授权日期:

1988-10-31

产品特点

Revised: June 2016
AN: 00139/2016
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMITOR 1 mg/ml Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
Medetomidine hydrochloride
1 mg/ml
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1 mg/ml
Propyl parahydroxybenzoate
0.2 mg/ml
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
DOGS:
For restraint, sedation and analgesia associated with clinical
examinations and procedures, minor surgery
and as premedication
prior to general anaesthesia
In combination with butorphanol for sedation and analgesia.
CATS:
For restraint and sedation.
In combination with ketamine for the induction of general anaesthesia
prior to surgical procedures
In combination with butorphanol for sedation and analgesia, and
combined with both butorphanol and ketamine for general anaesthesia.
As a premedicant before alfaxalone/alfadolone for general anaesthesia.
Revised: June 2016
AN: 00139/2016
Page 2 of 8
4.3
CONTRAINDICATIONS
Do not use in animals with heart failure, respiratory disease or
impaired liver or
kidney function, animals in shock, seriously debilitated animals, or
animals that
are stressed due extreme heat, cold or fatigue. Do not use in
conjunction with
sympathomimetic amines.
Do not use in dogs under 12 weeks of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
When Domitor is administered, the animal should be allowed to rest in
a
maximally quiet place. Before any procedure is started or other drugs
are
administered, sedation should be allowed to reach its peak effect,
which occurs at
about 10 to 30 min, depending on route of administration.
In extremely nervous, excited or agitated animals, the levels of
endogenous
catecholamines may be high. The pharmacological response elicited by
alpha-2
agonists (e.g. medetomidine) in such