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OPTIRAY Solution for injection or infusion (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Optiray 350 mg I/ml Solution for injection or infusion.

Qualitative and quantitative composition

1 ml solution contains 741 mg ioversol equivalent to 350 mg Iodine. Osmolality: 780 mosmoles/kg Viscosity: 14.3 mPa·s (at 25°C) Viscosity: 9 mPa·s (at 37°C) Contains Iodine per ml: 350 mg For the full ...

Pharmaceutical form

Solution for injection or infusion. Clear, colourless to faint yellow solution.

Therapeutic indications

This medicinal product is for diagnostic use only. Optiray 350 is a non-ionic X-ray contrast medium that is indicated in adults for use in coronary, peripheral, visceral, and renal arteriography, aortography ...

Posology and method of administration

Adults Recommended dosage schedule: Procedure Dosage* Maximum Total Dose Peripheral Arteriography 10-90 ml 250 ml Venography 50-100 ml 250 ml Left Ventriculography 30-50 ml 250 ml Coronary ...

Contraindications

Hypersensitivity to iodine-containing contrast media, the active substance, or to any of the excipients listed in section 6.1. Manifest hyperthyroidism

Special warnings and precautions for use

Serious or fatal reactions have been associated with the administration of iodinated X-ray contrast media. It is of utmost importance to be completely prepared to treat any contrast medium reaction. Procedures ...

Interaction with other medicinal products and other forms of interaction

The following interactions have been reported after the administration of other iodinated contrast media. They are generally accepted as being attributable to this class of contrast media. Renal toxicity ...

Fertility, pregnancy and lactation

Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. There are, however, no adequate ...

Effects on ability to drive and use machines

There is no known effect on the ability to drive and operate machines. However, because of the risk of early reactions driving or operating machinery is not advisable for 1 hour following the time of injection. ...

Undesirable effects

Frequencies for adverse drug reactions are defined as follows: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000) Not known (cannot ...

Overdose

As with all iodinated X-ray contrast media, overdoses of Optiray are potentially fatal and may affect the respiratory and cardiovascular system. Treatment should be symptomatic. Dialysis can be used to ...

Pharmacodynamic properties

Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar X-ray contrast media ATC code: V08AB07 Optiray 350 is a non-ionic X-ray contrast medium. Intravascular injection of Optiray opacifies ...

Pharmacokinetic properties

The pharmacokinetic profile of Optiray, together with its hydrophilic properties and a very low level of binding to serum and plasma proteins, indicate that Optiray is distributed within the extracellular ...

Preclinical safety data

There were no findings in the preclinical testing of Optiray which could be of relevance for the prescriber in recognising the safety of this product used for the authorised indications, and which are ...

List of excipients

Trometamol Trometamol hydrochloride Sodium calcium edetate Water for injections Sodium hydroxide and/or hydrochloric acid (for pH: 6.0 to 7.4)

Incompatibilities

No other medicinal product should be mixed with Optiray.

Shelf life

Shelf life: 3 years. Chemical and physical in-use stability has been demonstrated for 24 hours up to 37°C. After use, discard the remaining solution.

Special precautions for storage

Keep the container in the outer carton in order to protect from light. Protect from X-rays. Do not store above 30°C. Optiray can be stored for one month at 37°C in a contrast medium warmer with circulating ...

Nature and contents of container

Uncoloured vials and bottles composed of Type I Ph. Eur. glass. Vials are fitted with 20 mm latex-free bromobutyl rubber closures and aluminium cap seals. Bottles are fitted with 32 mm latex-free bromobutyl ...

Special precautions for disposal and other handling

ike all parenteral products, the vials and bottles of Optiray should be inspected visually for integrity of the container. Optiray vials and bottles are intended for single use only. Discard any unused ...

Marketing authorization holder

Guerbet, BP 57400, 95943, Roissy CdG cedex, France

Marketing authorization number(s)

PA0686/007/006

Date of first authorization / renewal of the authorization

Date of first authorisation: 22<sup>nd</sup> April 1993 Date of latest renewal: 22<sup>nd</sup> April 2008

Date of revision of the text

December 2016

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