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

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

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

זמין מ:

Lupin Australia Pty Limited

INN (שם בינלאומי):

Meropenem trihydrate

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: sodium carbonate

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

10 X 20 mL vials

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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

leaflet_short:

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

מצב אישור:

Licence status A

תאריך אישור:

2014-06-19

עלון מידע

1
Meropenem MaxRx CMI V 1 06/13
CONSUMER MEDICINE INFORMATION
Meropenem MaxRx
_Meropenem Powder for Injection _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Meropenem MaxRx. 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
MaxRx against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS, ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MEROPENEM MAXRX IS USED FOR
Meropenem MAxRx 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
MaxRx
belongs
to
a
group
of
medicines
called
carbapenem
antibiotics.
These
medicines work by killing the bacteria that are causing your
infection.
Meropenem MaxRx will not work
against fungal or viral infections (such as colds or flu).
Meropenem MaxRx is given by injection and is usually only used in
hospitals. It is available only
with a doctor's prescription.
2
Meropenem MaxRx CMI V 1 06/13
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 MaxRx is not addictive.
MEROPENEM MAXRX 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 MAXRX
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT TAKE MEROPENEM MAXRX IF YOU HAVE AN ALLERGY TO:
•
any medicine containing meropenem
•
any of the

מאפייני מוצר

1
Meropenem MaxRx PI V1 06/14
PRODUCT INFORMATION
MEROPENEM MAXRX
Meropenem Powder for Injection
NAME OF THE MEDICINE
Meropenem, as meropenem trihydrate.
Chemical Formula:
The chemical name of meropenem trihydrate is
(4_R_,5_S_,6_S_)‐3‐[[(3_S_,5_S_)‐5‐
[(Dimethylamino)carbonyl]pyrrolidin‐3‐yl]sulfanyl]‐6‐[(1_R_)‐1‐hydroxyphenolethyl]‐4‐methyl‐7‐oxo‐1‐
azabicyclo[3.2.0]hept‐2‐ene‐2‐carboxylic acid trihydrate.
Structural Formula:
Molecular formula: C
17
H
25
N
3
O
5
S.3H
2
O
Molecular weight: 437.52
CAS Number: 119478‐56‐7 meropenem trihydrate.
DESCRIPTION
Meropenem powder for injection is presented as a sterile white to
yellowish powder containing
meropenem trihydrate equivalent to meropenem, 500 mg or 1 g, blended
with sodium carbonate
anhydrous. Meropenem powder for injection contains 208 mg sodium
carbonate anhydrous for each
gram of meropenem (anhydrous potency).
MEROPENEM POWDER FOR INJECTION
500 MG 1 G
2
Meropenem MaxRx PI V1 06/14
_ACTIVE INGREDIENT _
Meropenem (as the trihydrate)
570 mg
1.14 g
Equivalent to anhydrous meropenem
500 mg
1 g
_EXCIPIENT _
Sodium carbonate anhydrous
104 mg
208 mg
PHARMACOLOGY
Meropenem is a carbapenem antibiotic for parenteral use, that is
stable to human dehydropeptidase‐
1 (DHP‐1).
Pharmacodynamics
Microbiology
Meropenem exerts its bactericidal action by interfering with vital
bacterial cell wall synthesis. The ease
with which it penetrates bacterial cell walls, its high level of
stability to all serine β‐lactamases and its
marked affinity for the Penicillin Binding Proteins (PBPs) explain the
potent bactericidal action of
meropenem against a broad spectrum of aerobic and anaerobic bacteria.
Bactericidal concentrations
are commonly the same as the minimum inhibitory concentrations (MICs).
Meropenem is stable in susceptibility tests and these tests can be
performed using normal routine
methods. _In vitro_ tests show that meropenem acts synergistically
with various antibiotics. It has been
demonstrated both _in vitro_ and _in vi