Posology : מינונים

2      DOSAGE AND ADMINISTRATION
2.1Instructions for Use in All Patients For Intravenous or Intramuscular Use
DO NOT MIX OR CO-INFUSE Ertapenem S.K.WITH OTHER MEDICATIONS.
DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
Ertapenem S.K. may be administered by intravenous infusion for up to 14 days     or   intramuscular    injection    for   up   to   7   days.   When      administered intravenously, Ertapenem S.K. should be infused over a period of 30 minutes.
Intramuscular administration of Ertapenem S.K. may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.


2.2 Treatment Regimen
13 years of age and older
The dose of Ertapenem S.K.in patients 13 years of age and older is 1 gram (g) given once a day [see Clinical Pharmacology (12.3)].


2.3    3 months to 12 years of age
The dose of Ertapenem S.K.in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).
Table 1 presents treatment guidelines for Ertapenem S.K..
Table 1
Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function* and Body Weight Daily Dose              Daily Dose            Recommended
Infection†                     (IV or IM)             (IV or IM)            Duration of Total Adults and Pediatric   Pediatric Patients 3        Antimicrobial
Patients 13 years of   months to 12 years of         Treatment age and older               age


Complicated intra-abdominal                  1g                   15 mg/kg               5 to 14 days infections                                           twice daily‡


Complicated skin and skin                  1g                   15 mg/kg              7 to 14 days¶ structure infections, including                                 twice daily‡ diabetic foot infections§


Community acquired pneumonia                   1g                  15 mg/kg               10 to 14 days# twice daily‡


Complicated urinary tract                  1g                   15 mg/kg              10 to 14 days# infections, including pyelonephritis                              twice daily‡ 

Acute pelvic infections including                                                         3 to 10 days 1g                   15 mg/kg postpartum endomyometritis,
twice daily‡ septic abortion and post-surgical gynecologic infections
*   defined as creatinine clearance   90 mL/min/1.73 m2
†   due to the designated pathogens [see Indications and Usage (1)] ‡   not to exceed 1 g/day
§
Ertapenem S.K.has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14.1)].
¶ adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral switch therapy)
# duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.



2.4  Patients with Renal Impairment
Ertapenem S.K. may be used for the treatment of infections in adult patients with renal impairment. In patients whose creatinine clearance is 30 mL/min/1.73 m2, no dosage adjustment is necessary. Adult patients with severe renal impairment (creatinine clearance 30 mL/min/1.73 m2) and end- stage renal disease
(creatinine clearance 10 mL/min/1.73 m2) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.
2.5 Patients on Hemodialysis
When adult patients on hemodialysis are given the recommended daily dose of 500 mg of Ertapenem S.K.within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If Ertapenem S.K.is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.


When only the serum creatinine is available, the following formula1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males:         (weight in kg) x (140-age in years)
(72) x serum creatinine (mg/100 mL)

Females: (0.85) x (value calculated for males)
2.6    Patients with Hepatic Impairment
No dose adjustment recommendations can be made in patients with hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
2.7 Preparation and Reconstitution for
Administration Vials
Adults and pediatric patients 13 years of age and older
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE Ertapenem S.K.WITH OTHER
MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (-D-
GLUCOSE).
Ertapenem S.K.MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO
ADMINISTRATION.
1.   Reconstitute the contents of a 1 g vial of Ertapenem S.K. with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21- gauge or smaller diameter needle. NOTE: Use with a needleless IV system is not recommended.
2.   Shake     well     to   dissolve   and    immediately    transfer   contents   of   the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection.
3. Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
Ertapenem S.K.MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
1. Reconstitute the contents of a 1 g vial of Ertapenem S.K. with 3.2 mL  of 1.0% lidocaine HCl injection2 (without epinephrine). Shake vial thoroughly to form solution.
2.   Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
3. The reconstituted IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE
ADMINISTERED INTRAVENOUSLY.
Pediatric patients 3 months to 12 years of age
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE Ertapenem S.K.WITH OTHER
MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (-D-
GLUCOSE).
Ertapenem S.K.MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO
ADMINISTRATION.
1. Reconstitute the contents of a 1 g vial of Ertapenem S.K.with 10 mL of  one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21- gauge or smaller diameter needle. NOTE: Use with a needleless IV system is not recommended.
2.   Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and dilute in 0.9%
Sodium Chloride Injection to a final concentration of 20 mg/mL or less.
Discard     vial   with   unused    portion   of Ertapenem      S.K.    reconstituted solution.
3. Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
Ertapenem S.K.MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
1. Reconstitute the contents of a 1 g vial of Ertapenem S.K. with 3.2 mL of 
1.0%    lidocaine       HCl   injection    (without     epinephrine).    Shake      vial thoroughly to form solution.
2.   Immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). Discard vial with unused portion of Ertapenem S.K. reconstituted solution.
1
Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976 2
Refer to the prescribing information for lidocaine HCl.



The reconstituted IM solution should be used within 1 hour after
3.
preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE
ADMINISTERED INTRAVENOUSLY.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Solutions of Ertapenem S.K. range from white to light yellow. Variations of color within this range do not affect the potency of the product.