VABOREM Powder for concentrate for solution for infusion Ref.[51371] Active ingredients: Meropenem Meropenem and Vaborbactam

Vaborem should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see sections 4.4 and 5.1).

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).

Table 1. Recommended intravenous dose for patients with a creatinine clearance (CrCl) ≥40 ml/min¹:

¹ As calculated using the Cockcroft-Gault formula
² Treatment may continue up to 14 days

Special populations

Elderly

No dose adjustment based on age is required (see section 5.2).

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). Doses adjusted for renal impairment should be administered after a dialysis session.

Table 2. Recommended intravenous doses for patients with a CrCl ≤39 ml/min¹:

¹ As calculated using the Cockcroft-Gault formula
² Refer to Table 1 for the recommended duration of treatment

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).

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.

There is no experience with overdose of Vaborem.

Limited post-marketing experience with meropenem alone indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.

In the event of overdose, discontinue Vaborem and institute general supportive treatment. In individuals with normal renal function, rapid renal elimination will occur.

Meropenem and vaborbactam can be removed by haemodialysis. In subjects with end stage renal disease (ESRD) administered 1 g meropenem and 1 g vaborbactam, the mean total recovery in dialysate following a haemodialysis session was 38% and 53% for meropenem and vaborbactam, respectively.

4 years.

After reconstitution: The reconstituted vial should be further diluted immediately.

After dilution: The chemical and physical in-use stability has been demonstrated for up to 4 hours at 25°C or within 22 hours at 2-8°C.

From a microbiological point of view, the medicinal product should be used immediately upon reconstitution and dilution.

Do not store above 25°C.

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

50 ml clear glass vial (Type 1) closed with a rubber (bromobutyl) stopper and aluminium overseal with flip-off cap.

The medicinal product is supplied in packs of 6 vials.

Standard aseptic techniques must be used for solution preparation and administration.

The powder for concentrate for solution for infusion must be reconstituted and further diluted prior to use.

Reconstitution

20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) should be withdrawn from a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection for each vial and reconstituted with the appropriate number of vials of meropenem/vaborbactam for the corresponding

Vaborem dosage:

• Reconstitute 2 vials for the Vaborem 2 g/2 g dose
• Reconstitute 1 vial for the Vaborem 1 g/1 g and Vaborem 0.5 g/0.5 g doses

After mixing gently to dissolve, the reconstituted meropenem/vaborbactam solution will have an approximate meropenem concentration of 0.05 g/ml and an approximate vaborbactam concentration of 0.05 g/ml. The final volume is approximately 21.3 ml. The reconstituted solution is not for direct injection. The reconstituted solution must be diluted before intravenous infusion.

Dilution

To prepare the Vaborem 2 g/2 g dose for intravenous infusion: Immediately after reconstitution of two vials, the entire reconstituted vial contents should be withdrawn from each of the two vials and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline). The final infusion concentration of meropenem and vaborbactam will be about 8 mg/ml each.

To prepare the Vaborem 1 g/1 g dose for intravenous infusion: Immediately after reconstitution of one vial, the entire reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline). The final infusion concentration of meropenem and vaborbactam will be about 4 mg/ml each.

To prepare the Vaborem 0.5 g/0.5 g dose for intravenous infusion: Immediately after reconstitution of one vial,10.5 ml of the reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline). The final infusion concentration of meropenem and vaborbactam will be 2 mg/ml each.

The diluted solution should be inspected visually for particulate matter. The colour of the diluted solution is clear to light yellow.

Any unused product or waste material should be disposed of in accordance with local requirements.