Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
ertapenem sodium
Merck Sharp & Dohme B.V.
J01DH03
ertapenem
Antibacterials for systemic use,
Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial
TreatmentTreatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:intra-abdominal infections;community-acquired pneumonia;acute gynaecological infections;diabetic foot infections of the skin and soft tissue.PreventionInvanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 26
Authorised
2002-04-18
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INVANZ 1 g powder for concentrate for solution for infusion 2. QUALITATIVE AND QUAN T ITATIVE COMPOSITION Each vial contains 1.0 g ertapenem. Excipient(s) with known effect Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg). For the full list of excipients, see section 6.1. 3. PHA RMACEUTICAL FORM Powder fo r concentrate for solution for infusion. White to off-white powder. 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment INVANZ is indicated in paediatri c patients (3 months to 17 years of age ) and in adults for t he treatment of the follow i ng infections when caused by bacteria kno wn or very likely to be susceptible to e rtapenem and w hen parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdo minal infections Community acquired pneumonia Acute gynaecol ogical infections Diabetic foot infections of the skin and soft tiss ue (see section 4.4) Prevention INVANZ is indicated in adults for the prophylaxis of surgical site infection following electiv e colorectal surgery (see section 4.4). Consideration shoul d be given to official gui d ance on the appropriate use of antibacter ial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment Adults and adolescents (13 to 17 years of age): The dose of INVANZ is 1 gram (g) given once a day by the intrave nous route ( see section 6.6). Infants and children (3 months to 12 years of age): The dose of INVANZ is 15 mg/kg given tw ice daily (not to exceed 1 g/day) by the intravenous route (see section 6.6). 3 Prevention Adults: To prevent surgical site infections following elective colore ctal surgery , the recommended dosage is 1 g administered as a single intravenous d ose to be comp leted within 1 hour prior to the surgical incision. Paediatric population The safety and efficacy of INVANZ in children below 3 month s of age have not yet been established. No data are available. Renal impairment INVANZ may be us Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INVANZ 1 g powder for concentrate for solution for infusion 2. QUALITATIVE AND QUAN T ITATIVE COMPOSITION Each vial contains 1.0 g ertapenem. Excipient(s) with known effect Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg). For the full list of excipients, see section 6.1. 3. PHA RMACEUTICAL FORM Powder fo r concentrate for solution for infusion. White to off-white powder. 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment INVANZ is indicated in paediatri c patients (3 months to 17 years of age ) and in adults for t he treatment of the follow i ng infections when caused by bacteria kno wn or very likely to be susceptible to e rtapenem and w hen parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdo minal infections Community acquired pneumonia Acute gynaecol ogical infections Diabetic foot infections of the skin and soft tiss ue (see section 4.4) Prevention INVANZ is indicated in adults for the prophylaxis of surgical site infection following electiv e colorectal surgery (see section 4.4). Consideration shoul d be given to official gui d ance on the appropriate use of antibacter ial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment Adults and adolescents (13 to 17 years of age): The dose of INVANZ is 1 gram (g) given once a day by the intrave nous route ( see section 6.6). Infants and children (3 months to 12 years of age): The dose of INVANZ is 15 mg/kg given tw ice daily (not to exceed 1 g/day) by the intravenous route (see section 6.6). 3 Prevention Adults: To prevent surgical site infections following elective colore ctal surgery , the recommended dosage is 1 g administered as a single intravenous d ose to be comp leted within 1 hour prior to the surgical incision. Paediatric population The safety and efficacy of INVANZ in children below 3 month s of age have not yet been established. No data are available. Renal impairment INVANZ may be us Baca dokumen lengkapnya