VISUDYNE Powder for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Visudyne 15 mg powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains 15 mg of verteporfin. After reconstitution, 1 ml contains 2 mg of verteporfin. 7.5 ml of reconstituted solution contains 15 mg of verteporfin. For the full list of excipients, see section ...
Pharmaceutical form
Powder for solution for infusion. Dark green to black powder.
Therapeutic indications
Visudyne is indicated for the treatment of: adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or adults with subfoveal ...
Posology and method of administration
Visudyne should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia. Posology Adults, including the elderly ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Visudyne is also contraindicated in patients with porphyria and in patients with severe hepatic impairment (see ...
Special warnings and precautions for use
Photosensitivity and exposure to light Patients who receive Visudyne will become photosensitive for 48 hours after the infusion. During that period, patients should avoid exposure of unprotected skin, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed in humans. Other photosensitising agents It is possible that concomitant use of other photosensitising medicinal products (e.g. tetracyclines, sulphonamides, ...
Fertility, pregnancy and lactation
Pregnancy No clinical data on exposed pregnancies are available for verteporfin. Studies in animals have shown teratogenic effects in one species (rat) (see section 5.3). The potential risk for humans ...
Effects on ability to drive and use machines
Following Visudyne treatment, patients may develop transient visual disturbances such as abnormal vision, vision decrease, or visual field defects that may interfere with their ability to drive or use ...
Undesirable effects
Most adverse reactions were mild to moderate and transient in nature. Undesirable effects reported in patients with pathological myopia were similar to those reported in patients with AMD. The most frequently ...
Overdose
Overdose of the medicinal product and/or light in the treated eye may result in non-selective nonperfusion of normal retinal vessels, with the possibility of severe vision decrease. Overdose of the medicinal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, Antineovascularisation agents ATC code: S01LA01 Mechanism of action Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists ...
Pharmacokinetic properties
The two regioisomers of verteporfin exhibit similar pharmacokinetic properties of distribution and elimination and thus both isomers are considered verteporfin as a whole from the pharmacokinetic perspective. ...
Preclinical safety data
Single and repeated dose toxicity The acute and light-dependent toxicity of verteporfin was characterised by dose dependent localised deep-tissue damage as a consequence of the pharmacological effect of ...
List of excipients
Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Incompatibilities
Visudyne precipitates in sodium chloride solution. Do not use normal sodium chloride solutions or other parenteral solutions. In the absence of compatibility studies, this medicinal product must not be ...
Shelf life
Shelf-life in the sealed vial: 4 years. Shelf-life after reconstitution and dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, ...
Special precautions for storage
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap. Pack containing 1 vial.
Special precautions for disposal and other handling
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution. Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be ...
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
Marketing authorization number(s)
EU/1/00/140/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 July 2000 Date of latest renewal: 05 May 2010
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