Ketabel 100 mg/ml solution for injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Ketamine hydrochloride

זמין מ:

Bela-Pharm GmbH & Co. KG

קוד ATC:

QN01AX03

INN (שם בינלאומי):

Ketamine hydrochloride

כמות:

10 percent

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

ketamine

מצב אישור:

Authorised

תאריך אישור:

2020-07-03

מאפייני מוצר

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