Gadovist solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gadobutrol

Available from:

Bayer AG

ATC code:

V08CA09

INN (International Name):

gadobutrol

Dosage:

604,72mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(5) glass vials 15ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-03-18

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gadovist 1.0 mmol/ml solution for injection in prefilled
syringe/cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 604.72 mg gadobutrol
(equivalent to 1.0 mmol gadobutrol containing
157.25 mg gadolinium).
1 syringe with 5.0 ml contains 3023.6 mg gadobutrol,
1 syringe with 7.5 ml contains 4535.4 mg gadobutrol,
1 syringe with 10 ml contains 6047.2 mg gadobutrol,
1 syringe with 15 ml contains 9070.8 mg gadobutrol,
1 syringe with 20 ml contains 12094.4 mg gadobutrol.
Excipient with known effect: 1 ml contains 0.00056 mmol (equivalent to
0.013 mg) of sodium (see
section 4.4)._ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in prefilled syringe/cartridge
Clear, colourless to pale yellow liquid.
Physico-chemical properties:
Osmolality at 37 °C: 1603 mOsm/kg H
2
O
Viscosity at 37 °C: 4.96 mPa·s
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. Gadovist is
indicated in adults and children of all ages
(including term neonates) for:

Contrast enhancement in cranial and spinal magnetic resonance imaging
(MRI).

Contrast enhanced MRI of liver or kidneys in patients with high
suspicion or evidence of having focal
lesions to classify these lesions as benign or malignant.

Contrast enhancement in magnetic resonance angiography (CE-MRA).
Gadovist can also be used for MR Imaging of pathologies of the whole
body.
It facilitates visualisation of abnormal structures or lesions and
helps in the differentiation between healthy
and pathological tissue.
Gadovist should only be used when essential diagnostic information
cannot be obtained with non-contrast
enhanced magnetic resonance imaging (MRI).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GADOVIST SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS
EXPERIENCED IN THE FIELD OF CLINICAL
MRI PRACTICE.
Method of administration
This medicinal product is for i