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SPC, UK: LEVOFLOXACIN Eye drops, solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Levofloxacin 5mg/ml Eye Drops Solution.

Qualitative and quantitative composition

1 ml of eye drops, solution, contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin. Excipient with known effect: One ml of eye drops, solution contains 0.05 mg benzalkonium chloride. ...

Pharmaceutical form

Eye drops, solution. Clear, pale yellow to pale greenish-yellow solution, practically free from visible particles. The pH of the solution is 6.0-6.8 and the osmolality is 270-320 mOsmol/kg.

Therapeutic indications

Levofloxacin 5 mg/ml eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms (see also sections ...

Posology and method of administration

Posology For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5. If different ...

Contraindications

Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in section 6.1, e.g. benzalkonium chloride.

Special warnings and precautions for use

Levofloxacin 5 mg/ml eye drops must not be injected sub-conjunctivally. The solution should not be introduced directly into the anterior chamber of the eye. Systemic fluoroquinolones have been associated ...

Interaction with other medicinal products and other forms of interaction

Specific drug interaction studies have not been conducted with levofloxacin eye drops. Since maximum plasma concentrations of levofloxacin after ocular administration are at least 1000 times lower than ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...

Effects on ability to drive and use machines

Levofloxacin has minor influence on the ability to drive and use machines. If there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating ...

Undesirable effects

Approximately 10% of patients can be expected to experience adverse reactions. The reactions are usually graded as mild or moderate, are transient, and are generally restricted to the eye. As the product ...

Overdose

The total amount of levofloxacin in a bottle of eye drops is too small to induce toxic effects after an accidental oral intake. If considered necessary, the patient can be observed clinically and supportive ...

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, antiinfectives, fluoroquinolones ATC code: S01AE05 Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin ...

Pharmacokinetic properties

After ocular instillation, levofloxacin is well maintained in the tear-film. In a healthy-volunteer study, mean tear-film concentrations of levofloxacin measured four and six hours after topical dosing ...

Preclinical safety data

Preclinical effects were observed only at exposures considerably in excess of the maximum human exposure after instillation of levofloxacin 5 mg/ml eye drops, indicating little relevance to clinical use. ...

List of excipients

Benzalkonium chloride (0.05 mg in 1 ml eye drops, solution) Sodium chloride Sodium hydroxide or hydrochloric acid (for pH adjustment) Water for injections

Incompatibilities

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

Shelf life

Shelf life Unopened bottle: 3 years. After first opening the bottle: 4 weeks.

Special precautions for storage

Unopened bottle: This medicinal product does not require any special storage conditions. Opened bottle: Do not store above 25°C. Keep bottle in the outer carton in order to protect from light.

Nature and contents of container

White LDPE 5 ml bottle with a white LDPE dropper and a white high density polyethylene (HDPE)/LDPE tamper-evident seal cap. Pack size: one bottle in a cardboard box.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/0946

Date of first authorization / renewal of the authorization

07/03/2016

Date of revision of the text

25/10/2018

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