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SPC: OPTIMARK Solution for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Optimark 500 micromol/ml solution for injection in pre-filled syringe. Optimark 500 micromol/ml solution for injection in vial.

Qualitative and quantitative composition

Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol. Each 15 ml syringe contains 4963.5 mg ...

Pharmaceutical form

Pre-filled syringe: Solution for injection in pre-filled syringe. Vial: Solution for injection in vial. Clear, colourless to pale yellow solution. pH: 6.0–7.5. Osmolality (37°C): 1000–1200 mOsm/kg.

Therapeutic indications

This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and ...

Posology and method of administration

Optimark should only be administered by physicians experienced in clinical MRI practice. To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, ...

Contraindications

Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1. Optimark is contraindicated: in patients with severe renal impairment ...

Special warnings and precautions for use

As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions. Some of these lesions may be seen on unenhanced, non-contrast MRI. Therefore, ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed. Optimark has been shown to cause interference in the measurement of serum calcium using the ortho- cresolphthalein complexone (OCP) colorimetric method. ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of gadoversetamide 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

Optimark has no or negligible influence on the ability to drive and use machines. Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly ...

Undesirable effects

Summary of the safety profile Most of the adverse reactions were of mild to moderate intensity and transient in nature. The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness. ...

Overdose

Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose). Clinical consequences of an overdose have not been reported. Acute toxicity symptoms are unlikely ...

Pharmacodynamic properties

Pharmacotherapeutic Group: MRI contrast media ATC code: V08CA06 Gadoversetamide is a chelate containing gadolinium which has paramagnetic properties and is responsible for the contrast enhancement effect ...

Pharmacokinetic properties

Distribution The pharmacokinetics of gadoversetamide conforms to a two compartment open-model. At the 100 micromol/kg dose, the mean distribution half life in normal subjects calculated by the method of ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity. No carcinogenicity ...

List of excipients

Versetamide Calcium hydroxide Calcium chloride dihydrate Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections

Incompatibilities

In the absence of compatibility studies, Optimark should not be mixed with other medicinal products.

Shelf life

Shelf-life: 3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...

Special precautions for storage

Pre-filled syringe: Keep the syringe in the outer carton in order to protect from light. Vial: Keep the vial in the outer carton in order to protect from light. Do not refrigerate or freeze. For storage ...

Nature and contents of container

Pre-filled syringe Optimark is filled in pre-filled syringes made of polypropylene. Syringe tip cap and piston are made of bromobutyl rubber. Pack sizes: 1 10 ml 10 10 ml 1 15 ml 10 15 ml 1 20 ml ...

Special precautions for disposal and other handling

Optimark is intended for single use only; any unused portions should be discarded. Do not use the solution if it is discoloured or particulate matter is present. If non-disposable equipment is used, scrupulous ...

Marketing authorization holder

Guerbet, 15, rue des Vanesses, 93420, Villepinte, France

Marketing authorization number(s)

Pre-filled syringe: 1 10 ml: EU/1/07/398/007 10 10 ml: EU/1/07/398/008 1 15 ml: EU/1/07/398/009 10 15 ml: EU/1/07/398/010 1 20 ml: EU/1/07/398/011 10 20 ml: EU/1/07/398/012 10 30 ml EU/1/07/398/014 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 July 2007 Date of latest renewal: 15 June 2012

Πηγαίο έγγραφο

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