XYDALBA 500 MG — DIN 02480522

What is XYDALBA?

XYDALBA 500 MG contains DALBAVANCIN (DALBAVANCIN HYDROCHLORIDE) : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02480522, held by ENDO OPERATIONS LTD., supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 01-May-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is XYDALBA used for?

XYDALBA (dalbavancin for injection) is indicated for: • treatment of adults and pediatric patients aged 3 months and older 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 anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains). XYDALBA is not active against gram-negative bacteria; therefore, combination therapy may be clinically indicated if the ABSSSI is polymicrobial and includes a suspected or documented gram- negative pathogen. XYDALBA has been studied in the treatment of cellulitis/erysipelas, major cutaneous abscesses, or wound infections. Other types of complicated skin infections (including diabetic foot ulcer, necrotizing fasciitis, or decubitus ulcer) have not been studied. To reduce the development of drug-resistant bacteria and maintain the effectiveness of XYDALBA and other antibacterial drugs, XYDALBA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Adults: The recommended dosage regimen for XYDALBA in adult patients with ABSSSI is 1500 mg, administered either as a single dose or 1000 mg followed one week later by 500 mg. XYDALBA should be administered over 30 minutes by intravenous infusion. Pediatrics (≥ 6 years of age to < 18 years of age): The recommended dosage regimen for XYDALBA in children (≥ 6 years of age) and adolescent patients with ABSSSI is a single dose of 18 mg / kg of body weight (maximum of 1500 mg). XYDALBA should be administered over 30 minutes by intravenous infusion. Pediatrics (≥ 3 months of age to < 6 years of age): The recommended dosage regimen for XYDALBA in infant and children patients (aged from 3 months to less than 6 years) with ABSSSI is a single dose of 22.5 mg / kg of body weight (maximum of 1500 mg). XYDALBA should be administered over 30 minutes by intravenous infusion. Renal Impairment in Adults: In patients with renal impairment whose known creatinine clearance is < 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended dose for XYDALBA should be reduced to either 1000 mg administered as a single infusion or 750 mg followed one week later by 375 mg. Administration: After reconstitution and dilution, XYDALBA is to be administered via intravenous infusion, using a total infusion time of 30 minutes. Do not co-infuse XYDALBA with other medications or electrolytes. Sodium chloride containing solutions may cause precipitation and should not be used. The compatibility of reconstituted XYDALBA with intravenous medications, additives, or substances other than 5% Dextrose Injection, has not been established. If a common intravenous line is being used to administer other drugs in addition to XYDALBA, the line should be flushed before and after each XYDALBA infusion with 5% Dextrose Injection. Reconstitution: XYDALBA must be reconstituted with either Sterile Water for Injection, or 5% Dextrose Injection, and subsequently diluted only with 5% Dextrose Injection, to a final concentration of 1 mg/mL to 5 mg/mL. For each 500 mg vial, reconstitute with 25 mL of either Sterile Water for Injection, or 5% Dextrose Injection. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

XYDALBA (dalbavancin for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin and telavancin.

Warnings and precautions

Infusion-Related Reactions: XYDALBA is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of XYDALBA can cause reactions that resemble “Red-Man Syndrome”, including flushing of the upper body, urticaria, pruritus and/or rash. Stopping or slowing the infusion may result in cessation of these reactions. Mixed Infections: In mixed infections in which gram-negative bacteria are suspected, patients should also be treated with an appropriate antibacterial agent(s) against gram-negative bacteria. Clostridium difficile-Associated Disease (CDAD): CDAD has been reported with use of many antibacterial agents, including XYDALBA. CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent. CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Hypersensitivity Reactions: Serious hypersensitivity (anaphylactic/anaphylactoid) and skin reactions have been reported in patients treated with XYDALBA. If an allergic reaction occurs, treatment with XYDALBA should be discontinued and appropriate therapy for the allergic reaction should be instituted. Before using XYDALBA, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy. Potential for Microbial Overgrowth: The use of any antibiotics, including XYDALBA, may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken.