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SPC: LUCENTIS Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lucentis 10 mg/ml solution for injection.

Qualitative and quantitative composition

One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult ...

Pharmaceutical form

Solution for injection. Clear, colourless to pale yellow aqueous solution.

Therapeutic indications

Lucentis is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative ...

Posology and method of administration

Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology Adults The recommended dose for Lucentis in adults is 0.5 mg given as a single intravitreal ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with active or suspected ocular or periocular infections. Patients with active severe intraocular inflammation. ...

Special warnings and precautions for use

Intravitreal injection-related reactions Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed. For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis in wet AMD and PM, see section 5.1. For the adjunctive use of laser photocoagulation ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception in females Women of childbearing potential should use effective contraception during treatment. Pregnancy For ranibizumab no clinical data on exposed pregnancies ...

Effects on ability to drive and use machines

The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8). Patients who experience these signs must not drive or use machines ...

Undesirable effects

Summary of the safety profile The majority of adverse reactions reported following administration of Lucentis are related to the intravitreal injection procedure. The most frequently reported ocular adverse ...

Overdose

Cases of accidental overdose have been reported from the clinical studies in wet AMD and post- marketing data. Adverse reactions associated with these reported cases were intraocular pressure increased, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents ATC code: S01LA04 Mechanism of action Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human ...

Pharmacokinetic properties

Following monthly intravitreal administration of Lucentis to patients with neovascular AMD, serum concentrations of ranibizumab were generally low, with maximum levels (C<sub>max</sub>) generally below ...

Preclinical safety data

Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects. ...

List of excipients

α,α-trehalose dihydrate Histidine hydrochloride, monohydrate Histidine Polysorbate 20 Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Prior to use, the unopened vial may be kept at room temperature (25°C) for up to 24 hours. ...

Nature and contents of container

Vial-only pack: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution. Vial + filter needle pack: One vial (type I glass) with a stopper (chlorobutyl rubber) containing ...

Special precautions for disposal and other handling

Vial-only pack The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed ...

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

EU/1/06/374/002 EU/1/06/374/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016

Πηγαίο έγγραφο

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