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OZURDEX Intravitreal implant in applicator (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

OZURDEX 700 micrograms intravitreal implant in applicator.

Qualitative and quantitative composition

One implant contains 700 micrograms of dexamethasone. For the full list of excipients, see section 6.1.

Pharmaceutical form

Intravitreal implant in applicator. Disposable injection device, containing a rod-shaped implant. which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length.

Therapeutic indications

OZURDEX is indicated for the treatment of adult patients with: Visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable ...

Posology and method of administration

OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1. Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, ...

Special warnings and precautions for use

Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment. Proper aseptic injection ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Systemic absorption is minimal and no interactions are anticipated.

Fertility, pregnancy and lactation

Pregnancy Studies in animals have shown teratogenic effects following topical ophthalmic administration (see section 5.3). There are no adequate data from the use of intravitreally administered dexamethasone ...

Effects on ability to drive and use machines

OZURDEX may have a moderate influence on the ability to drive and use machines. Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see section 4.8). They ...

Undesirable effects

Summary of the safety profile The most commonly-reported adverse events reported following treatment with OZURDEX are those frequently observed with ophthalmic steroid treatment or intravitreal injections ...

Overdose

If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, antiinflammatory agents ATC code: S01BA01 Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting oedema, fibrin deposition, ...

Pharmacokinetic properties

Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single intravitreal ...

Preclinical safety data

Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the maximum dose for human indicating little relevance to clinical use. No mutagenicity, carcinogenicity, ...

List of excipients

Ester terminated 50:50 poly D,L-lactide-co-glycolide Acid terminated 50:50 poly D,L-lactide-co-glycolide

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Each pack contains: One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator. The applicator ...

Special precautions for disposal and other handling

OZURDEX is for single use only. Each applicator can only be used for the treatment of a single eye. If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used. ...

Marketing authorization holder

Allergan Pharmaceuticals Ireland, Castlebar Road, Co. Mayo, Westport, Ireland

Marketing authorization number(s)

EU/1/10/638/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 27/07/2010 Date of latest renewal: 23/03/2015

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