Meronem Powder for Solution for Intravenous Injection or Infusion 1 gvial

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

Meropenem trihydrate 1140mg eqv anhydrous Meropenem

متاح من:

SUMITOMO PHARMA ASIA PACIFIC PTE. LTD.

ATC رمز:

J01DH02

جرعة:

1000 mg

الشكل الصيدلاني:

INJECTION, POWDER, FOR SOLUTION

تركيب:

Meropenem trihydrate 1140mg eqv anhydrous Meropenem 1 g/vial

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Sumitomo Pharma Co., Ltd. (BULK BLEND MANUFACTURER)

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1996-12-06

نشرة المعلومات

Page 1 of 13 

MERONEM IV 
Trademark 

FOR INTRAVENOUS ADMINISTRATION 

QUALITATIVE AND QUANTITATIVE COMPOSITION 

Meronem IV is presented as a sterile white powder
containing meropenem; 500 mg or 1g as the 
trihydrate blended with anhydrous sodium carbonate
for constitution. Meronem IV injection 
contains 208 mg sodium carbonate
for each gram of meropenem (anhydrous potency). 

VIAL FOR I.V. INJECTION OR INFUSION 
MERONEM 500 MG 
MERONEM 1000 MG 
Active ingredient: 
Meropenem trihydrate  
equivalent to anhydrous meropenem 

570 mg 
500 mg 

1140 mg 
1000 mg 
Excipient: 
Anhydrous sodium carbonate 

104 mg 

208 mg 

For each gram of meropenem (anhydrous potency) the vial contains 90 mg (3.9 mmol) of 
sodium. 

PHARMACEUTICAL FORM 

Powder for solution for intravenous injection or infusion. 

THERAPEUTIC INDICATIONS 

Meronem IV is indicated for treatment, in adults and
children, of the following infections caused 
by single or multiple bacteria sensitive to meropenem. 

-  
Pneumonias and Nosocomial Pneumonias 
-  
Urinary Tract Infections  
-  
Intra-abdominal Infections 
-  
Gynaecological Infections, such as endometritis and pelvic inflammatory disease 
-  
Skin and Skin Structure Infections 
-  
Meningitis 
-  
Septicaemia   
-  
Empiric treatment,
for presumed infections in adult patients with febrile neutropenia, used 
as monotherapy or in combination with anti-viral or anti-fungal agents. 

Meronem IV has proved efficacious
alone or in combination with other antimicrobial agents in 
the treatment of polymicrobial infections. 

There is no experience in paediatric patients with neutropenia or primary or secondary 
immunodeficiency. 

POSOLOGY AND METHOD OF ADMINISTRATION 

Page 2 of 13 

ADULTS 

The dosage and duration
of t

خصائص المنتج

Page 1 of 14
MERONEM IV
Trademark
FOR INTRAVENOUS ADMINISTRATION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meronem IV is presented as a sterile white powder containing
meropenem; 500 mg or 1g as the
trihydrate blended with anhydrous sodium carbonate for constitution.
Meronem IV injection
contains 208 mg sodium carbonate for each gram of meropenem (anhydrous
potency).
VIAL FOR I.V. INJECTION OR INFUSION
MERONEM 500 MG
MERONEM 1000 MG
Active ingredient:
Meropenem trihydrate
equivalent to anhydrous meropenem
570 mg
500 mg
1140 mg
1000 mg
Excipient:
Anhydrous sodium carbonate
104 mg
208 mg
For each gram of meropenem (anhydrous potency) the vial contains 90 mg
(3.9 mmol) of
sodium.
PHARMACEUTICAL FORM
Powder for solution for intravenous injection or infusion.
THERAPEUTIC INDICATIONS
Meronem IV is indicated for treatment, in adults and children, of the
following infections caused
by single or multiple bacteria sensitive to meropenem.
-
Pneumonias and Nosocomial Pneumonias
-
Urinary Tract Infections
-
Intra-abdominal Infections
-
Gynaecological Infections, such as endometritis and pelvic
inflammatory disease
-
Skin and Skin Structure Infections
-
Meningitis
-
Septicaemia
-
Empiric treatment, for presumed infections in adult patients with
febrile neutropenia, used
as monotherapy or in combination with anti-viral or anti-fungal
agents.
Meronem IV has proved efficacious alone or in combination with other
antimicrobial agents in
the treatment of polymicrobial infections.
There
is
no
experience
in
paediatric
patients
with
neutropenia
or
primary
or
secondary
immunodeficiency.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Page 2 of 14
The dosage and duration of therapy shall be established depending on
type and severity of
infection and the condition of the patient.
The recommended daily dosage is as follows:
500 mg IV every 8 hours in the treatment of pneumonia, UTI,
gynaecological infections such as
endometritis, skin and skin structure infections.
1 g IV every 8 hours in the treatment of nosocomial pneumonias,
peritonitis, pr