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LOTEMAX Eye-drops, suspension (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lotemax 0.5% w/v Eye Drops, Suspension.

Qualitative and quantitative composition

The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml). Each drop contains 0.19 mg loteprednol etabonate. Excipient with known effect: Benzalkonium Chloride (0.01%). For the full list of excipients, ...

Pharmaceutical form

Eye-drops, suspension. Milky-white.

Therapeutic indications

Treatment of post-operative inflammation following ocular surgery.

Posology and method of administration

Posology Adults and elderly One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period. The duration of treatment should not exceed 2 weeks. ...

Contraindications

Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection ...

Special warnings and precautions for use

Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. ...

Interaction with other medicinal products and other forms of interaction

Since loteprednol etabonate is not detected in plasma following the topical administration of Lotemax, it is not expected to affect the pharmacokinetics of systemically administered medicinal products. ...

Pregnancy and lactation

Pregnancy For Lotemax no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown and Lotemax ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. If there are any transient effects on vision, the patient should be advised to wait until these subside before driving ...

Undesirable effects

Reactions associated with ophthalmic steroids include elevated intraocular pressure in steroid responsive patients, which may be associated with optic nerve damage, visual acuity and field defects, posterior ...

Overdose

No case of overdose has been reported. Acute overdosage is unlikely to occur via the ophthalmic route.

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroid ATC code: S01BA14 Mechanism of action Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No ...

Pharmacokinetic properties

Results from oral and ocular administration of Lotemax in normal volunteers have shown that there are low or undetectable concentrations of either unchanged material or the metabolite. Results from a bioavailability ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity. Embryotoxicity and teratogenic effects were observed in reproductive toxicity ...

List of excipients

Disodium edetate Glycerol Povidone Purified water Tyloxapol Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster) Benzalkonium chloride

Incompatibilities

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

Shelf life

Shelf life: 2,5 mL: 15 months (unopened). 5 mL, 10 mL: 2 years (unopened). Discard any unused contents 28 days after first opening the bottle.

Special precautions for storage

Do not store above 25°C. Do not freeze. Store the container in an upright position.

Nature and contents of container

Lotemax is available in the following packaging configurations: 2.5 mL and 5 mL supplied in a white low density polyethylene bottle (7.5 mL) with a white control drop tip and a pink polypropylene cap. ...

Special precautions for disposal and other handling

Store the container in an upright position.

Marketing authorization holder

Bausch & Lomb GmbH, Brunsbütteler Damm 165-173, 13581, Berlin, Germany

Marketing authorization number(s)

PL 17947/0001

Date of first authorization / renewal of the authorization

31/03/2008

Date of revision of the text

October 2017

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