Meropenem-AFT

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Meropenem trihydrate 570mg equivalent to Meropenem 500mg;  

Boleh didapati daripada:

AFT Pharmaceuticals Ltd

INN (Nama Antarabangsa):

Meropenem trihydrate 570 mg (Equivalent to Meropenem 500 mg)

Dos:

500 mg

Borang farmaseutikal:

Powder for injection

Komposisi:

Active: Meropenem trihydrate 570mg equivalent to Meropenem 500mg   Excipient: Sodium carbonate

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Shenzhen Haibin Pharmaceutical Co Ltd

Tanda-tanda terapeutik:

Meropenem-AFT is indicated for treatment, in adults and children, of the following infections caused by multiple susceptible bacteria and as empiric therapy prior to the identification of the causative organisms: · Lower respiratory tract infections · Urinary tract infections, including complicated infections · Intra-abdominal infections · Gynaecological infections, including postpartum infections · Skin and skin structure infections · Meningitis · Septicaemia · Empiric treatment, including initial monotherapy, for presumed bacterial infections in host-compromised, neutropenic patients Because of its broad spectrum of bactericidal activity against gram positive and gram-negative aerobic and anaerobic bacteria, meropenem is effective for the treatment of polymicrobial infections.

Ringkasan produk:

Package - Contents - Shelf Life: Vial, glass, Type 1, 26 mL - 10 dose units - 3 years from date of manufacture stored at or below 30°C protect from light - Vial, glass, Type 1, 20 mL - 10 dose units - 3 years from date of manufacture stored at or below 30°C protect from light

Tarikh kebenaran:

2013-07-19

Ciri produk

Page 1 of 12
DATA SHEET
1
MEROPENEM-AFT (MEROPENEM TRIHYDRATE POWDER FOR INJECTION OR
INFUSION)
(Meropenem-AFT) Meropenem trihydrate powder for injection or infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem-AFT 500mg
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
Meropenem-AFT 1g
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients:
Each 500 mg vial contains 104 mg sodium carbonate.
Each 1 g vial contains 208 mg sodium carbonate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to light yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem-AFT is indicated for the treatment, in adults and children,
of the following infections
caused by single or multiple susceptible bacteria and as empiric
therapy prior to the identification of
the causative organisms (see sections 4.4 and 5.1):
•
Lower Respiratory Tract Infections
•
Urinary Tract Infections, including complicated infections
•
Intra-abdominal Infections
•
Gynecological Infections, including postpartum infections
•
Skin and Skin Structure Infections
•
Meningitis
•
Septicaemia
•
Empiric treatment, including initial monotherapy, for presumed
bacterial infections in host-
compromised, neutropenic patients
Because of its broad spectrum of bactericidal activity against
Gram-positive and Gram-negative
aerobic and anaerobic bacteria, meropenem is effective for the
treatment of polymicrobial infections.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS
Page 2 of 12
Dosage range is 1.5 g – 6 g daily in three divided doses.
Usual dose
500 mg to 1 g by intravenous administration every 8 hours depending on
type and severity of
infection, the known or expected susceptibility of the pathogen(s) and
the condition of the patient.
Exceptions
1.
Febrile episodes in neutropenic patients – the dose should be 1 g
every 8 hours.
2.
Meningitis – the dose should be 2 g every