Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
INVANZ is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):
INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dose of INVANZ is 1 gram (g) given once a day by the intravenous route (see section 6.6).
The dose of INVANZ is 15 mg/kg given twice daily (not to exceed 1 g/day) by the intravenous route (see section 6.6).
To prevent surgical site infections following elective colorectal surgery, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
The safety and efficacy of INVANZ in children below 3 months of age have not yet been established. No data are available.
INVANZ may be used for the treatment of infections in adult patients with mild to moderate renal impairment. In patients whose creatinine clearance is >30 mL/min/1.73 m², no dosage adjustment is necessary. There are inadequate data on the safety and efficacy of ertapenem in patients with severe renal impairment to support a dose recommendation. Therefore, ertapenem should not be used in these patients (see section 5.2). There are no data in children and adolescents with renal impairment.
There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation. Therefore, ertapenem should not be used in these patients.
No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
The recommended dose of INVANZ should be administered, except in cases of severe renal impairment (see Renal impairment).
Intravenous administration: INVANZ should be infused over a period of 30 minutes.
The usual duration of therapy with INVANZ is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s). When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
For instructions on preparation of the medicinal product before administration, see section 6.6.
No specific information is available on the treatment of overdose with ertapenem. Overdosing of ertapenem is unlikely. Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity. In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions. In paediatric clinical studies, a single intravenous (IV) dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
However, in the event of an overdose, treatment with INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.
Ertapenem can be removed to some extent by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
2 years.
After reconstitution: Diluted solutions should be used immediately. If not used immediately, in use storage times are the responsibility of the user. Diluted solutions (approximately 20 mg/mL ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2 to 8°C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator. Do not freeze solutions of INVANZ.
Do not store above 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
15 mL Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal.
Supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.
For single use only.
Reconstituted solutions should be diluted in sodium chloride 9 mg/mL (0.9%) solution immediately after preparation.
Preparation for intravenous administration: INVANZ must be reconstituted and then diluted prior to administration.
Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9%) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve. (See section 6.4.) Dilution
For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9%) solution; or
For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9%) solution and discard. Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 mL vial of sodium chloride 9 mg/mL (0.9%) solution.
Infuse over a period of 30 minutes.
Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9%) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve. (See section 6.4.) Dilution
For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9%) solution for a final concentration of 20 mg/mL or less; or
For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9%) solution for a final concentration of 20 mg/mL or less.
Infuse over a period of 30 minutes.
Compatibility of INVANZ with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits. Solutions of INVANZ range from colourless to pale yellow. Variations of colour within this range do not affect potency.
Any unused product or waste material should be disposed of in accordance with local requirements.
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