OFTAQUIX Eye drops, solution (2020)

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Περιεχόμενα

1. Name of the medicinal product

Oftaquix 5 mg/ml eye drops, solution.

2. Qualitative and quantitative composition

One 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 ...

3. Pharmaceutical form

Eye drops, solution. Clear, light yellow to light greenish-yellow solution, practically free of visible particulate matter. Isotonic solution adjusted to physiological pH-value range.

4.1. Therapeutic indications

Oftaquix 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 ...

4.2. 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 ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Oftaquix 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. As with other anti-infectives, prolonged use may ...

4.5. Interaction with other medicinal products and other forms of interaction

Specific drug interaction studies have not been conducted with Oftaquix 5 mg/ml eye drops. Since maximum plasma concentrations of levofloxacin after ocular administration are at least 1000 times lower ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

Oftaquix 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 ...

4.8. 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

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

5.2. 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 ...

5.3. Preclinical safety data

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

6.1. List of excipients

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

6.2. Incompatibilities

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

6.3. Shelf life

3 years. After first opening: to be used within 28 days.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions. Keep the container tightly closed.

6.5. Nature and contents of container

5 ml of solution is supplied in a 5 ml white low-density polyethylene (LDPE) bottle with a LDPE dropper tip and a tan high-density polyethylene (HDPE) screw cap. Pack size: 1 5 ml.

6.6. 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.

7. Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

8. Marketing authorization number(s)

PL 16058/0006

9. Date of first authorization / renewal of the authorization

Date of latest renewal: 29 July 2006

10. Date of revision of the text

26 November 2020

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