Dormostart 1 mg/ml Solution for Injection for Dogs and Cats

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Medetomidine Hydrochloride

可用日期:

Alfasan Nederland B.V.

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:

2024-02-13

产品特点

Issued: February 2024
AN: 01697/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dormostart 1 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Medetomidine hydrochloride……………………………..…1.0 mg
(equivalent to 0.85 mg of medetomidine)
Excipients:
Methyl parahydroxybenzoate (E218) ............................... 1.0
mg
Propyl parahydroxybenzoate ...........................................
0.2 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
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.
Issued: February 2024
AN: 01697/2022
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 medetomidine 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 lev