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SPC, UK: Ozurdex (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Allergan Ltd
Διεύθυνση :
Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
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Δωρεάν εγγραφή

Name of the medicinal product

OZURDEX 700 micrograms intravitreal implant in applicator.

Qualitative and quantitative composition

One implant contains 700 micrograms of dexamethasone. For a 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 macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1). OZURDEX is ...

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

OZURDEX is contraindicated in: 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 ...

Special warnings and precautions for use

Any intravitreous injection can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment. Proper aseptic injection techniques must always be used. ...

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

Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see section 4.8). They should not drive or use machines until this has resolved.

Undesirable effects

BRVO/CRVO a) The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled ...

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, 6-month efficacy studies prior to dosing and on day 7, 30, 60, and 90 following the intravitreal implant containing 350 µg or ...

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.

Ημερομηνία λήξης

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

1 pack contains: 1 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, do not use. Once the foil pouch is ...

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

27/07/2010

Date of revision of the text

09/2012
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