MEROPENEM APOTEX meropenem (as trihydrate) 1000 mg powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
11-10-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
meropenem trihydrate, Quantity: 1141 mg (Equivalent: meropenem, Qty 1000 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Meropenem trihydrate
Pharmaceutical form:
Injection, powder for
Composition:
Excipient Ingredients: sodium carbonate
Administration route:
Intravenous
Units in package:
10 vials
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Meropenem is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics: Community acquired lower respiratory tract infection; Hospital acquired lower respiratory tract infection; Complicated urinary tract infection; Febrile neutropenia; Intra-abdominal and gynaecological (poly microbial) infections; Complicated skin and skin structure infections; Meningitis; Septicaemia
Product summary:
Visual Identification: White to slightly yellow powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-12-18
Patient Information leaflet
MEROPENEM IV APOTEX
_Meropenem trihydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about meropenem. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Meropenem is used to treat many
different types of infection, such as:
•
infections of the lungs
•
infections of the kidney or
bladder (urinary tract infection)
•
febrile neutropenia
•
infections around the stomach or
bowel
•
infections of the vagina and
womb
•
serious skin infections
•
infections in the lining of the
brain (meningitis)
•
infections in the blood stream
(septicaemia)
Meropenem is given by injection and
is usually only used in hospitals.
_HOW IT WORKS_
Meropenem belongs to a group of
medicines called carbapenem
antibiotics. These medicines work by
killing the bacteria that are causing
your infection.
Meropenem will not work against
fungal or viral infections (such as
colds or flu).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine is not recommended
for use in children under the age of 3
months.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
meropenem
•
any other antibiotics such as other
carbapenems, penicillins,
cephalosporins, or beta lactam
antibiotics
•
any of the ingredients listed at the
end of this leaflet
Some of the s
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –MEROPENEM
APOTEX (MEROPENEM AS MEROPENEM TRIHYDRATE)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Meropenem, as meropenem trihydrate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 ML VIAL
Contains meropenem trihydrate equivalent to meropenem 500 mg.
30 ML VIAL
Contains meropenem trihydrate equivalent to meropenem 1000 mg.
EXCIPIENTS WITH KNOWN EFFECT:
Sodium
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Meropenem powder for injection is presented as a sterile white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem is indicated for treatment of the following infections, in
adults and children (aged
3 months and over), when the causative organisms are known or
suspected to be resistant to
commonly used antibiotics:
•
Community acquired lower respiratory tract infection
•
Hospital acquired lower respiratory tract infection
•
Complicated urinary tract infection
•
Febrile neutropenia
•
Intra-abdominal and gynaecological (poly microbial) infections
•
Complicated skin and skin structure infections
•
Meningitis
•
Septicaemia
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Usual dose
500 mg to 1 g by intravenous administration every 8 hours depending on
type and severity of
infection, the known or suspected 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 8 hours.
2
As with other antibiotics, caution may be required in using meropenem
as monotherapy in
critically ill patients with known or suspected _Pseudomonas
aeruginosa_ lower respiratory
tract infection.
Regular sensitivity testing is recommended when treating _Pseudomonas
aeruginosa_
infection.
Meropenem should be given as an intravenous bolus injection over
approximately 5 minutes
or by intravenous infusion over approximately 15 to 30 minutes (see
Constitution and
compatibility). There is limited saf
Read the complete document
