Lucentis 10 mg/ml solution for injectionRanibizumab - Ireland[爱尔兰药品]

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Lucentis 10 mg/ml solution for injectionRanibizumab

2014-02-08 22:19:07 来源: 作者: 【大中小】浏览:812次评论:0条

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

Lucentis 10 mg/ml solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains 10 mg ranibizumab. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.

Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

Sterile, clear, colourless to pale yellow aqueous solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Lucentis is indicated in adults for:

the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).

the treatment of visual impairment due to diabetic macular oedema (DME) (see section 5.1).

the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1).

4.2 Posology and method of administration

Single-use vial for intravitreal use only.

Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Treatment of wet AMD

In wet AMD the recommended dose for Lucentis is 0.5 mg given monthly as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.

Treatment is given monthly and continued until maximum visual acuity is achieved i.e. the patient`s visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment.

Thereafter patients should be monitored monthly for visual acuity.

Treatment is resumed when monitoring indicates loss of visual acuity due to wet AMD. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.

Treatment of visual impairment due to either DME or macular oedema secondary to RVO (see also section 5.1)

The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.

Treatment is given monthly and continued until maximum visual acuity is achieved i.e the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment. If there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended.

Thereafter patients should be monitored monthly for visual acuity.

Treatment is resumed when monitoring indicates loss of visual acuity due to DME or to macular oedema secondary to RVO. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.

Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO

There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1). When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be admin