Xydalba

2). Paediatric patients The recommended dose of dalbavancin is a single dose based on the age and weight of the patient. 2). 3 Renal impairment Dose adjustments are not required for adult and paediatric patients with mild or moderate renal impairment (creatinine clearance  30 to 79 ml/min).

Dose adjustments are not required for adult patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis. 2). 5 mL/kg/h, or requirement for dialysis.

2, but no recommendation on a posology can be made. Hepatic impairment No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A). 2). Method of administration Intravenous use Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period.

6.

Summary of the safety profile In Phase 2/3 clinical studies, 2 473 adult patients received dalbavancin administered as either a single infusion of 1 500 mg or as 1 000 mg followed one week later by 500 mg. 3 %) and were generally of mild or moderate severity.

Tabulated list of adverse reactions (Table 1) The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin. Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000).

6 Table 1. System Organ Class Common Uncommon Rare Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis Blood and lymphatic system disorders anaemia, thrombocytosis, eosinophilia, leucopenia, neutropenia Immune system disorders anaphylactoid reaction Metabolism and nutrition disorders decreased appetite Psychiatric disorders insomnia Nervous system disorders headache dysgeusia, dizziness Vascular disorders flushing, phlebitis Respiratory, thoracic and mediastinal disorders cough bronchospasm Gastrointestinal disorders nausea, diarrhoea constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting Skin and subcutaneous tissue disorders pruritus, urticaria, rash Reproductive system and breast disorders vulvovaginal pruritus General disorders and administration site conditions infusion-related reactions Investigations blood lactate dehydrogenase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl transferase increased Description of selected adverse reactions Class adverse reactions Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk.

Hypersensitivity reactions Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.

Clostridioides (formerly Clostridium) difficile-associated diarrhoea Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening.

8). In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered. These patients must never be treated with medicinal products that suppress the peristalsis.

Infusion-related reactions Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions. Rapid intravenous infusions of glycopeptide 4 antibacterial agents can cause reactions including flushing of the upper body, urticaria, pruritus, and/or rash.

Stopping or slowing the infusion may result in cessation of these reactions. Renal impairment Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited. 2). 5 mL/kg/h, or requirement for dialysis.

1). Non-susceptible organisms The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken. Limitations of the clinical data There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart).

In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only. There is no experience with dalbavancin in the treatment of severely immunocompromised patients.

1.