Ketabel 100 mg/ml solution for injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ketamine hydrochloride

Disponibil de la:

Bela-Pharm GmbH & Co. KG

Codul ATC:

QN01AX03

INN (nume internaţional):

Ketamine hydrochloride

Dozare:

10 percent

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

ketamine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2020-07-03

Caracteristicilor produsului

Health Products Regulatory Authority
21 June 2021
CRN00CCVJ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketabel 100 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Ketamine
​100 mg
​
(equivalent to ketamine hydrochloride
​115.34 mg)
​
​
​
EXCIPIENTS:
​
​
Chlorobutanol hemihydrate
​5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, cattle, sheep, goats, horses, pigs, guinea pigs, hamsters,
rabbits, rats, and mice.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product may be used in combination with a sedative for:
- Immobilisation
- Sedation
- General anaesthesia
4.3 CONTRAINDICATIONS
Do not use in animals presenting with:
- severe hypertension,
- cardio-respiratory deficiency,
- hepatic or renal dysfunction.
Do not use in animals with glaucoma.
Do not use in animals with eclampsia or pre-eclampsia.
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
Do not use the product as a sole anaesthetic agent in any of the
target species.
Do not use for surgical intervention on pharynx, larynx, trachea or
bronchial tree, if sufficient relaxation is not ensured by
administration of a muscle relaxant (intubation obligatory).
Do not use in ocular surgical interventions;
Do not use in animals undergoing a myelogram procedure.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For very painful and major surgical interventions, as well as for
maintenance of anaesthesia, a combination with injectable or
inhalational anaesthetics is indicated.
Health Products Regulatory Authority
21 June 2021
CRN00CCVJ
Page 2 of 6
As muscle relaxation required for surgical procedures cannot be
achieved with ketamine alone, additional muscle-relaxants
should be used concomitantly.
For improvement of anaesthesia or prolongation o