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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

HEXVIX Powder and solvent for intravesical solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hexvix 85 mg, powder and solvent for intravesical solution.

Qualitative and quantitative composition

Each vial of powder contains 85 mg hexaminolevulinate (as hexaminolevulinate hydrochloride). After reconstitution in 50 ml of solvent, 1 ml of the solution contains 1.7 mg hexaminolevulinate, which corresponds ...

Pharmaceutical form

Powder and solvent for intravesical solution. Powder: white to off-white or pale yellow. Solvent: clear, colourless solution.

Therapeutic indications

This medicinal product is for diagnostic use only. Hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of ...

Posology and method of administration

Hexvix cystoscopy should only be performed by healthcare professionals trained specifically in Hexvix cystoscopy. The bladder should be drained before the instillation. Adults (including the elderly) ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Porphyria.

Special warnings and precautions for use

The possibility of hypersensitivity including serious anaphylactic/anaphylactoid reactions should always be considered (see section 4.8). Advanced life support facilities should be readily available. ...

Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed with hexaminolevulinate.

Fertility, pregnancy and lactation

Pregnancy There are no or limited data on the use of hexaminolevulinate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to the reproductive toxicity (see ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Most of the reported adverse reactions were transient and mild or moderate in intensity. The most frequently reported adverse reactions from clinical studies were bladder spasm, reported by 2.4% of the ...

Overdose

No case of overdose has been reported. No adverse events have been reported with prolonged instillation times exceeding 180 minutes (3 times the recommended instillation time), in one case 343 minutes. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other diagnostic agents ATC code: V04CX In vitro studies have shown a considerable build-up of porphyrin fluorescence in malignant urothelium after exposure to hexaminolevulinate. ...

Pharmacokinetic properties

In vivo autoradiography studies in rats after intravesical administration have shown high concentrations of hexaminolevulinate in the bladder wall. After intravesical instillation of radiolabelled hexaminolevulinate ...

Preclinical safety data

Studies in rats and dogs have not indicated any risks for systemic toxicity. Seven-day intravesical tolerance studies, without light exposure, were performed in rats and dogs. The study in rats showed ...

List of excipients

Powder: None Solvent: Disodium phosphate dihydrate Potassium dihydrogen phosphate Sodium chloride Hydrochloric acid Sodium hydroxide Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 4 years. After dilution with the solvent: Chemical and physical stability of the solution has been demonstrated for 2 hours at 2°C-8°C. From a microbiological point of view, the product should ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

Pack of one 10 ml Type I colourless glass vial with butyl rubber stopper containing powder and one 50 ml cyclic olefin copolymer syringe with plunger stopper (bromobutyl rubber) and plunger rod, containing ...

Special precautions for disposal and other handling

No special requirements for disposal. Hexaminolevulinate may cause sensitisation by skin contact. Handling instructions for the pharmacist or other healthcare professionals: All steps should be performed ...

Marketing authorization holder

Ipsen Limited, 190 Bath Road, Slough, SL1 3XE, UK

Marketing authorization number(s)

PL 34926/0017

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 September 2004 Date of latest renewal: 10 September 2009

Date of revision of the text

2 January 2019

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