Description

1.GENERIC NAME Dalbavancin for Injection 500 mg (Lyophilized) 2.QUALITATIVE AND QUANTITATIVE COMPOSITION Each Vial Contains: Dalbavancin Hydrochloride Eq. to Dalbavancin 500 mg Excipients q.s. 3.DOSAGE FORM AND STRENGTH : Injection 500 mg (Lyophilized) 4.CLINICAL PARTICULARS Therapeutic indication Dalbavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin susceptible and methicillin resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus an ginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). Posology and method of administration Recommended Dosing The recommended dose of Dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg Special population: Elderly: No dose adjustment is necessary Renal impairment: Dose adjustments are not required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 to 79 ml/min). Dose adjustments are not required for patients receiving regularly scheduled haemodialysis (3 times/week), and Dalbavancin may be administered without regard to the timing of haemodialysis. In patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg Hepatic impairment: No dose adjustment of Dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A). Caution should be exercised when prescribing Dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing. Paediatric population: The safety and efffcacy of Dalbavancin in children aged from birth to < 18 years has not yet been established. Method of use Intravenous use. For instructions on reconstitution and dilution of the medicinal product before administration, Reconstitution Instructions: Aseptic technique must be used for reconstitution and dilution of Dalbavancin. ●The content of each vial must be reconstituted by slowly adding 25 ml of water for injections. ●Do not shake. To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes. ●The reconstituted concentrate in the vial contains 20 mg/ml Dalbavancin. ●The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles. ●The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion. ●To dilute the reconstituted concentrate, the appropriate volume of the 20 mg / ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5 %) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg Dalbavancin. ●After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml Dalbavancin ●The solution for infusion must be clear, colourless to yellow solution with no visible particles.