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SPC, New Zealand: DOTAREM Solution for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dotarem (bottles and pre-filled syringes) 0.5 mmol/mL solution for injection.

Qualitative and quantitative composition

Per 100 mL of solution: Gadoteric acid* 27.932 g corresponding to DOTA 20.246 g corresponding to gadolinium oxide 9.062 g * Gadoteric acid: complex gadolinium of 1, 4, 7, 10 tetraazacyclododecane-N,N',N' ...

Pharmaceutical form

Solution for injection in bottles and prefilled syringes. Clear, colourless to pale yellow solution. Osmolality: 1350 mOsm.kg -1 Viscosity at 20°C: 3.2 mPa.s Viscosity at 37°C: 2.0 mPa.s pH: 6.5 to 8.0 ...

Therapeutic indications

This medicinal product is for diagnostic use only. Magnetic resonance imaging for: cerebral and spinal disease, diseases of the vertebral column, and other whole body pathologies (including angiography ...

Posology and method of administration

Dose The lowest effective dose should be used. Adult population The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults. In angiography, depending on the results of the examination being performed, ...

Contraindications

Hypersensitivity to gadoteric acid, to meglumine or to any medicinal products containing gadolinium.

Special warnings and precautions for use

Do not use by intrathecal route. Take care to maintain strictly intravenous injection: extravasation may result in local intolerance reactions, requiring the usual local care. The usual precaution measures ...

Interaction with other medicinal products and other forms of interaction

No interactions with other medicinal products have been observed. Formal drug interaction studies have not been carried out. Concomitant medications to be taken into account Beta-blockers, vasoactive substances, ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of gadoteric acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Ambulant patients while driving vehicles or operating machinery should take into account that nausea may incidentally ...

Undesirable effects

Side effects in association with the use of gadoteric acid are usually mild to moderate in intensity and transient in nature. Injection site reactions, nausea and headache are the most frequently observed ...

Overdose

Gadoteric acid can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF). For advice on the management of overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: paramagnetic contrast media for MRI ATC code: V08CA02 Gadoteric acid has paramagnetic properties allowing MRI contrast enhancement. It has no specific pharmacodynamic activity ...

Pharmacokinetic properties

Following intravenous injection, gadoteric acid is mainly distributed in the extracellular fluid. It is not bound to plasma albumin. In patients with normal renal function, the plasma half-life is about ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction. In acute toxicity studies ...

List of excipients

Meglumine Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 30°C. Do not freeze.

Nature and contents of container

Bottles: Single bottles containing 5 mL, 10 mL, 15 mL, 20 mL, 60 mL and 100 mL, closed by an elastomeric stopper. Pre-filled syringes: Single disposable syringes containing 10 mL, 15 mL and 20 mL with ...

Special precautions for disposal and other handling

Pre-filled syringes: Screw the piston rod onto the syringe and intravenously inject the quantity of the product required for the examination. Bottles: Prepare a syringe with a needle. Remove the plastic ...

Marketing authorization holder

Manufactured by: Guerbet, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, FRANCE, www.guerbet.com Distributed in NZ by: Obex Medical Limited, P O Box 26511, Epsom, AUCKLAND, Telephone: (09) 630 3456, Toll ...

Date of first authorization / renewal of the authorization

Date of first approval: 06 November 1997

Date of revision of the text

10 October 2017

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