HEXVIX Powder and solvent for intravesical solution (2022)
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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. <u>Powder:</u> white to off-white or pale yellow. <u>Solvent:</u> 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 health care professionals trained specifically in Hexvix cystoscopy. The bladder should be drained before the instillation. Posology Adults (including the ...
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 2.0% 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
<b>Pharmacotherapeutic group:</b> Other diagnostic agents <b>ATC code:</b> V04CX06 Mechanism of Action After intravesical instillation of hexaminolevulinate, porphyrins will accumulate intracellularly ...
Pharmacokinetic properties
<em>In vivo</em> autoradiography studies in rats after intravesical administration have shown high concentrations of hexaminolevulinate in the bladder wall. After intravesical instillation of radiolabelled ...
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
<u>Powder:</u> None. <u>Solvent:</u> 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
4 years. <u>After dilution with the solvent:</u> 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 be ...
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
Photocure ASA, Hoffsveien 4, NO-0275 Oslo, N/A, Norway
Marketing authorization number(s)
PA1024/003/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23<sup>rd</sup> February 2007 Date of last renewal: 17<sup>th</sup> September 2009
Date of revision of the text
February 2022
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