MEROPENEM- meropenem injection, powder, for solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

MEROPENEM (UNII: FV9J3JU8B1) (MEROPENEM ANHYDROUS - UNII:YOP6PX0BAO)

Pieejams no:

Hospira, Inc.

SNN (starptautisko nepatentēto nosaukumu):

MEROPENEM

Kompozīcija:

MEROPENEM 500 mg in 10 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Meropenem for Injection I.V. is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species. Meropenem for Injection I.V. is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Bacteroides fragilis , B. thetaiotaomicron , and Peptostreptococcus species. Meropenem for Injection I.V. is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis, and penicillin-susceptible isolates of Streptococcus pneumoniae. Meropenem for Injection I.V. has been found to be effective in eliminating co

Produktu pārskats:

Meropenem for Injection I.V. is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20° to 25°C (68°–77°F) [see USP].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

MEROPENEM- MEROPENEM INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEROPENEM FOR INJECTION I.V. SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEROPENEM FOR
INJECTION I.V.
MEROPENEM FOR INJECTION, USP (I.V.)
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.2)
6/2018
INDICATIONS AND USAGE
Meropenem for Injection I.V. is a penem antibacterial indicated for
the treatment of:
Complicated skin and skin structure infections (adult patients and
pediatric patients 3 months of age and older only).
(1.1)
Complicated intra-abdominal infections (adult and pediatric patients).
(1.2)
Bacterial meningitis (pediatric patients 3 months of age and older
only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Meropenem for Injection I.V. and
other antibacterial drugs, Meropenem for Injection I.V. should only be
used to treat or prevent infections that are proven
or strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for
complicated skin and skin structure infections
(cSSSI) for adult patients. When treating infections caused by
_Pseudomonas aeruginosa_, a dose of 1 gram every 8
hours is recommended. (2.1)
1 gram every 8 hours by intravenous infusion over 15 minutes to 30
minutes for intra-abdominal infections for adult
patients. (2.1)
1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL)
over 3 minutes to 5 minutes for adult patients.
(2.1)
Dosage should be reduced in adult patients with renal impairment.
(2.2)
RECOMMENDED MEROPENEM FOR INJECTION I.V. DOSAGE SCHEDULE FOR ADULT
PATIENTS WITH RENAL IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
DO SE
(DEPENDENT ON TYPE OF INFECTION)
DOSING INTERVAL
Greater than 50
Recommended dose (500 mg cSSSI and 1 gram Intra-
abdominal)
Every 8 hours
26 to 50
R