BACQURE 500 INJECTION

Land: Sydafrika

Sprog: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgængelig fra:

Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort

Dosering:

See ingredients

Lægemiddelform:

INJECTION

Sammensætning:

EACH VIAL CONTAINS CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mg IMIPENEM 500,0 mg

Autorisation status:

Registered

Autorisation dato:

2010-04-06

Indlægsseddel

APPLICANT/PHCR:
Ranbaxy Pharmaceuticals (Pty) Ltd
PRODUCT PROPRIETARY NAME:
BACQURE 500
DOSAGE FORM AND STRENGTH:
Powder for injection; Each bottle contains Imipenem 500 mg and
Cilastatin sodium equivalent to Cilastatin 500 mg
DATE OF AMENDMENT:
June 2021
Page 1 of 8
1.5.5 PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
BACQURE 500 POWDER FOR INJECTION
Imipenen and Cilastatin
Sugar free
Contains sodium: 36,14 mg per bottle
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE BACQURE 500
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
WHAT IS IN THE LEAFLET
1.
What BACQURE 500 is and what it is used for
2.
What you need to know before you take BACQURE 500
3.
How to take BACQURE 500
4.
Possible side effects
5.
How to store BACQURE 500
6.
Contents of the pack and other information
1. WHAT BACQURE 500 IS AND WHAT IT IS USED FOR
APPLICANT/PHCR:
Ranbaxy Pharmaceuticals (Pty) Ltd
PRODUCT PROPRIETARY NAME:
BACQURE 500
DOSAGE FORM AND STRENGTH:
Powder for injection; Each bottle contains Imipenem 500 mg and
Cilastatin sodium equivalent to Cilastatin 500 mg
DATE OF AMENDMENT:
June 2021
Page 2 of 8
BACQURE 500 belongs to a group of medicines called thienamycins. It
kills a wide range of
bacteria (germs) that cause infections in various parts of the body.
BACQURE 500 is used for the treatment of several bacterial infections,
except meningitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE BACQURE 500
YOU SHOULD NOT RECEIVE BACQURE 500:
•
if you have had an allergic reaction to imipenem and cilastatin or
similar antibiotics (including
penicillin or cephalosporin) or to any of the ingredients (listed in
section 6). (An allergic
reaction may include rash, itching, swelling of
face/lips/tongue/hands/feet or breathing
difficulties.)
•
if you are pregnant or planning to become pregnant or breastfeeding.
•
if you are suffering from meningitis (which is inflammation of the
membranes surrounding
the brain and

Produktets egenskaber

APPLICANT/PHCR:
Ranbaxy Pharmaceuticals (Pty) Ltd
PRODUCT PROPRIETARY NAME:
BACQURE 500
DOSAGE FORM AND STRENGTH:
Powder for injection; Each bottle contains Imipenem 500 mg and
Cilastatin sodium equivalent to Cilastatin 500 mg
DATE OF AMENDMENT:
June 2021
Page 1 of 27
1.5.5 PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
BACQURE 500 Powder for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains imipenem (sterile) equivalent to anhydrous
imipenem 500 mg and
cilastatin sodium (sterile) equivalent to cilastatin 500 mg.
Sugar free
Contains sodium: 36,14 mg per bottle
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder for injection
White to pale yellow powder filled in 100 ml moulded clear glass
infusion bottle sealed with
rubber plug and flip off seal. After reconstitution a clear, pale
yellow to yellow coloured solution
is formed.
4. CLINICAL PARTICULARS
APPLICANT/PHCR:
Ranbaxy Pharmaceuticals (Pty) Ltd
PRODUCT PROPRIETARY NAME:
BACQURE 500
DOSAGE FORM AND STRENGTH:
Powder for injection; Each bottle contains Imipenem 500 mg and
Cilastatin sodium equivalent to Cilastatin 500 mg
DATE OF AMENDMENT:
June 2021
Page 2 of 27
4.1 THERAPEUTIC INDICATIONS
BACQURE 500 is indicated for the treatment of the following infections
caused by susceptible
strains of the designated micro-organisms in the conditions listed
below:
INTRA-ABDOMINAL INFECTIONS
_Enterococcus _
_faecal _
_is, _
_Staphylococcus _
_aureus _
_(penicillinase-producing _
_strains)*, _
_Staphylococcus epidermidis, Citrobacter species, Enterobacter
species, Escherichia coli, _
_Klebsiella _
_species, _
_Morganella _
_morganii*, _
_Proteus _
_species, _
_Pseudomonus _
_aeruginosa, _
_Bifidobacterium species, Clostridium species, Eubacterium species,
Peptococcus species, _
_Peptostreptococcus species, Propionibacterium species*, Bacteroides
species including B. _
_fragilis, Fusobacterium species. _
_ _
LOWER RESPIRATORY TRACT INFECTIONS
_Staphylococcus aureus (penicillinase-producing strains