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SPC, UK: TOBRADEX Susp. (Drops) (2015)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Alcon Laboratories UK Ltd.
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
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Name of the medicinal product

TOBRADEX 3mg/ml/1mg/ml Eye Drops, Suspension.

Qualitative and quantitative composition

Each ml contains: Tobramycin 3mg, Dexamethasone 1mg. For full list of excipients, see section 6.1

Pharmaceutical form

Eye Drops, Suspension. White to off-white suspension.

Therapeutic indications

Prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults and children aged 2 years and older.

Posology and method of administration

Adults One drop instilled into the conjunctival sac(s) every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the ...

Contraindications

Hypersensitivity to tobramycin or dexamethasone or to any of the excipients listed in section 6.1 Herpes simplex keratitis Vaccinia, varicella and other viral disease of the cornea and conjunctiva Mycobacterial ...

Special warnings and precautions for use

TOBRADEX is for topical use only and not for injection or oral use. Prolonged use of topical ophthalmic corticosteroids (i.e., longer than the maximum duration used in clinical trials [24 days]) may result ...

Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions have been described with topical ocular dosing. Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems.

Fertility pregnancy and lactation

Pregnancy There are no adequate data from the use of TOBRADEX in pregnant women. Animal studies with subcutaneous administration of tobramycin have not revealed any teratogenic effects. High systemic doses ...

Effects on ability to drive and use machines

TOBRADEX has no or negligible influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed. As with any eye drop, temporarily ...

Undesirable effects

Summary of the safety profile In clinical studies involving over 1600 patients, TOBRADEX was administered up to six times daily. No serious ophthalmic or systemic adverse reactions related to TOBRADEX ...

Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one bottle or tube. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory agents and anti-infectives in combination, corticosteroids and anti-infectives in combination ATC code: S01CA01 Dexamethasone The efficacy of corticosteroids ...

Pharmacokinetic properties

Tobramycin Animal studies have shown that tobramycin is absorbed into the cornea following ocular administration. Following systemic administration to patients with normal renal function, a plasma half-life ...

Preclinical safety data

The systemic toxicity profile of the individual actives is well established. Preclinical effects of tobramycin and dexamethasone were observed only at exposures considered sufficiently in excess of the ...

List of excipients

Disodium edetate Hydroxyethylcellulose Benzalkonium chloride Purified water Sodium chloride Sodium sulphate anhydrous Sulphuric acid for pH adjustment and / or Sodium hydroxide for pH adjustment Tyloxapol ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years. After the first opening of the container, the sterile ophthalmic suspension should not be used longer than four weeks.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

5ml dropper container (LDPE) and screw cap (polypropylene). Pack size: 1 5ml.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Alcon Laboratories UK, Ltd. Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom

Marketing authorization number(s)

PL 00649/0119

Date of first authorization / renewal of the authorization

31/01/2001 / 30/04/2010

Date of revision of the text

07 May 2015