VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G [SIN17224P]
Active ingredients: VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G
Product Info
VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G
[SIN17224P]
Product information
Active Ingredient and Strength | MEROPENEM TRIHYDRATE EQV MEROPENEM - 1 G |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | ACS DOBFAR S.P.A. - ITALY |
Registration Number | SIN17224P |
Licence Holder | A. MENARINI SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J01DH52 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Vaborem is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):
Complicated urinary tract infection (cUTI), including pyelonephritis
Complicated intra-abdominal infection (cIAI)
Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosing
4.2 Posology and method of administration
Posology
Table 1 shows the recommended intravenous dose for patients with a creatinine clearance (CrCl) ≥40 ml/min (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations
Elderly
No dose adjustment based on age is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Renal impairment
Table 2 shows the recommended dose adjustments for patients with a CrCl ≤39 ml/min.
Meropenem and vaborbactam are removed by haemodialysis (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Doses adjusted for renal impairment should be administered after a dialysis session.

Hepatic impairment
No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
The safety and efficacy of meropenem/vaborbactam in children and adolescents younger than 18 years of age have not yet been established. No data are available.
Method of administration
Intravenous use.
Vaborem is administered by intravenous infusion over 3 hours.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Hypersensitivity to any carbapenem antibacterial agent.
Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, cephalosporins or monobactams).
