MEROPENEM GH meropenem (as trihydrate) 1 g powder for injection vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

meropenem trihydrate, Quantity: 1140 mg (Equivalent: meropenem, Qty 1000 mg)

Disponibbli minn:

Lupin Australia Pty Limited

INN (Isem Internazzjonali):

Meropenem trihydrate

Għamla farmaċewtika:

Injection, powder for

Kompożizzjoni:

Excipient Ingredients: sodium carbonate

Rotta amministrattiva:

Intravenous

Unitajiet fil-pakkett:

10 X 20 mL vials

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Visual Identification: Before reconstitution : White to yellowish powder,,After reconstitution: Clear solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2014-06-19

Fuljett ta 'informazzjoni

CONSUMER MEDICINE INFORMATION
MEROPENEM GH
(MEROPENEM TRIHYDRATE) POWDER FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Meropenem GH. 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 taking
Meropenem GH 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 need to read it again.
WHAT MEROPENEM GH IS
USED FOR
Meropenem GH is an antibiotic
used in adults and children to
treat certain serious infections
caused by bacteria, 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 GH belongs to a
group of medicines called
carbapenem antibiotics. These
medicines work by killing the
bacteria that are causing your
infection.
Meropenem GH will not work
against fungal or viral infections
(such as colds or flu).
Meropenem GH is an injection
and is usually only used in
hospitals. It is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
Meropenem GH is not addictive.
MEROPENEM GH IS NOT
RECOMMENDED FOR USE IN
CHILDREN UNDER THE AGE OF
3 MONTHS.
Safety and effectiveness in
children younger than 3 months
have not been established.
BEFORE YOU ARE GIVEN
MEROPENEM GH
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE MEROPENEM GH IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
meropenem;
•
any other carbopenems,
penicillins or other beta-
lactam antibiotics;
•
any of th

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION – MEROPENEM GH
(MEROPENEM (AS TRIHYDRATE)) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Meropenem (as meropenem trihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MEROPENEM GH
500 MG
1 G
_ACTIVE INGREDIENT _
Meropenem (as trihydrate)
570 mg
1.14 g
Equivalent to anhydrous meropenem
500 mg
1 g
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Meropenem GH: sterile powder with a white to yellow appearance.
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 (polymicrobial) 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.
Meropenem GH v5.0
Page 2 of 13
(meropenem (as trihydrate)) powder for injection
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.
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