QUOFENIX Powder for concentrate for solution for infusion Ref.[28025] Active ingredients: Delafloxacin

Posology

The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion. Switch to delafloxacin 450 mg tablet orally every 12 hours is possible at the discretion of the physician. The total duration of treatment is 5 to 14 days for ABSSSI and 5 to 10 days for CAP.

Special population

Elderly

No dose adjustment is required. As per fluoroquinolone class patients aged over 60 years are at increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and 5.2).

Renal impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min). Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2). Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).

Hepatic impairment

No dosage adjustment is necessary (see section 5.2).

Paediatric population

Quofenix is contraindicated in children and adolescents (see section 4.3).

Method of administration

Intravenous use.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study. Treatment of overdose with delafloxacin should consist of observation and general supportive measures.

4 years.

Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25°C or at 2 to 8°C. From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

Do not freeze.

This medicinal product does not require any special storage conditions.

For storage conditions after dilution of the medicinal product, see section 6.3.

20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.

Pack-size: 10 vials.

Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg vial.

• The vial should be vigorously shaken until contents are completely dissolved. The reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution.
• The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
• Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial.
• The required dose of Quofenix reconstituted solution should be aseptically transferred from the vial to a 250 mL intravenous bag. (Any unused portion of the reconstituted solution should be discarded).
• After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using a total infusion time of 60 minutes.

Quofenix must not be co-infused with other medications. If a common intravenous line is being used to administer other medicinal products in addition to Quofenix the line should be flushed before and after each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W. This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements