MEROPENEM SANDOZ 500 mg INJECTION

البلد: جنوب أفريقيا

اللغة: الإنجليزية

المصدر: South African Health Products Regulatory Authority (SAHPRA)

متاح من:

Sandoz South Africa (Pty) Ltd

جرعة:

See ingredients

الشكل الصيدلاني:

INJECTION

تركيب:

EACH VIAL CONTAINS MEROPENEM TRIHYDRATE EQUIVALENT TO MEROPENEM 500,0 mg

الوضع إذن:

Canceled

تاريخ الترخيص:

2017-09-04

نشرة المعلومات

RANBAXY PHARMACEUTICALS (PTY) LTD
INJECTION, 500 MG & 1 G
MERCIDE 500/ MERCIDE 1 G (MEROPENEM)
DATE OF AMENDMENT: APRIL 2021
Page 1 of 11
1.5.5 CLEAN PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
MERCIDE 500 (Injection)
MERCIDE 1 G (Injection)
Meropenem
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN MERCIDE

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist,
nurse or other
health care provider.

MERCIDE has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours
WHAT IS IN THIS LEAFLET
1.
What MERCIDE is and what it is used for
2.
What you need to know before you are given MERCIDE
3.
How MERCIDE will be administered
4.
Possible side effects
5.
How to store MERCIDE
6.
Contents of the pack and other information
S4
RANBAXY PHARMACEUTICALS (PTY) LTD INJECTION, 500 MG & 1 G
MERCIDE 500/ MERCIDE 1 G (MEROPENEM)
DATE OF AMENDMENT: APRIL 2021
Page 2 of 11
1.
WHAT MERCIDE IS AND WHAT IT IS USED FOR
MERCIDE contains meropenem. Meropenem belongs to a group of medicines
known as
carbapenem antibiotics.
MERCIDE is used for treatment of a variety of infections caused by
susceptible bacteria.
MERCIDE is used to treat the following in adults and children aged 3
months and older:

Infection affecting the lungs (pneumonia)

Complicated urinary tract infections

Inflammatory infections affecting the pelvic area

Skin Infections

Acute bacterial infection of the brain (meningitis)

A serious bloodstream infection (Septicaemia)

Infections in the abdomen

MERCIDE may be used in the management of neutropenic patients
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE MERCIDE
MERCIDE SHOULD NOT BE ADMINISTERED TO YOU IF:

if you have ever had an allergic reaction to meropenem or to any of
the ingredient in
MERCIDE listed in section 6 of the leaflet (an allergic reaction may
include skin rash,
itching, swelling o

خصائص المنتج

RANBAXY PHARMACEUTICALS (PTY) LTD
INJECTION, 500 MG & 1 G
MERCIDE 500/ MERCIDE 1 G (MEROPENEM)
DATE OF AMENDMENT: APRIL 2021
Page 1 of 21
1.5.5 CLEAN PROPOSED PROFESSIONAL PRESCRIBING INFORMATION
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
MERCIDE 500 (Injection)
MERCIDE 1 G (Injection)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MERCIDE 500
Each vial contains:
Meropenem (sterile) equivalent to anhydrous meropenem 500 mg.
Sugar free
MERCIDE 1 G
Each vial contains:
Meropenem (sterile) equivalent to anhydrous meropenem 1g.
Sugar Free
3.
PHARMACEUTICAL FORM
White to pale yellow crystalline powder in clear glass vial. After
reconstitution a clear,
colourless to pale yellow coloured solution is formed.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
MERCIDE is indicated for treatment of the following infections caused
by single or
multiple susceptible bacteria and as empiric therapy prior to the
identification of the
causative organisms:
ACUTE EXACERBATION OF CHRONIC BRONCHITIS AND PNEUMONIA DUE TO:
_Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus spp,
Escherichia _
_coli, Haemophilus influenzae, Haemophilus parainfluenzae, Pseudomonas
aeruginosa, _
S4
RANBAXY PHARMACEUTICALS (PTY) LTD
INJECTION, 500 MG & 1 G
MERCIDE 500/ MERCIDE 1 G (MEROPENEM)
DATE OF AMENDMENT: APRIL 2021
Page 2 of 21
_Branhamella catarrhalis, Klebsiella pneumoniae, Klebsiella spp,
Enterobacter cloacae, _
_Enterobacter spp., Acinetobacter. _
PNEUMONIA IN CHILDREN DUE TO:
_Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus
influenzae, _
_Pseudomonas aeruginosa. _
URINARY TRACT INFECTIONS IN ADULTS AND CHILDREN, INCLUDING
COMPLICATING INFECTIONS
DUE TO:
_Escherichia coli, Haemophilus influenzae, Pseudomonas aeruginosa,
Enterobacter _
_cloacae, Morganella morganii, Proteus mirabilis, Serratia marcescens,
Citrobacter _
_freundii. _
PELVIC INFLAMMATORY DISEASE (INCLUDING TUBO-OVARIAN ABSCESS) AND
ENDOMETRITIS
DUE TO:
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
haemolyticus, _
_Staphylococcus spp., Staphy