MEROPENEM

Main information

  • Trade name:
  • MEROPENEM APOTEX meropenem (as trihydrate) 500 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEROPENEM APOTEX meropenem (as trihydrate) 500 mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218843
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218843

MEROPENEM APOTEX meropenem (as trihydrate) 500 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

18/12/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MEROPENEM APOTEX meropenem (as trihydrate) 500 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

9/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10 vials

(S4) Prescription Only Medicine

Components

1. MEROPENEM APOTEX meropenem (as trihydrate) 500 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

White to slightly yellow powder

Active Ingredients

Meropenem trihydrate

570.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:21:18 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Meropenem IV APOTEX

Contains the active ingredient meropenem (as trihydrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

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.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

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.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Meropenem IV APOTEX powder for

injection. It contains the active

ingredient meropenem trihydrate.

It is used to treat:

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.

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.

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).

There is no evidence that this

medicine is addictive.

Use in children

This medicine 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

this medicine

When you must not be given

it

Do not take this medicine if:

You are hypersensitive to, or

have had an allergic reaction to,

meropenem or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

tell your doctor immediately.

The expiry date (EXP) printed

on the pack has passed.

MEROPENEM IV APOTEX POWDER FOR INJECTION

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines,

any other antibiotics such as other

carbapenems, penicillins,

cephalosporins or monobactams

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

gastrointestinal or stomach

problems, particularly colitis.

liver or kidney problems,

including dialysis.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breastfeed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

meropenem. These include:

probenecid - a medicine used to

treat gout

sodium valproate - a medicine

used to treat epilepsy or mania.

These medicines may be affected by

meropenem or may affect how well it

works. If you are taking any of these

you may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with meropenem.

How this medicine is

given

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much will you be given

Your doctor will decide what dose of

meropenem you will need depending

on certain factors such as your type

of infection and your age. The usual

dose is 500mg to 1g injected every 8

hours. If you have meningitis you

may require more, while a lower

dose may be used for children or if

you have kidney problems.

How it is given

Meropenem is injected into your

vein. It must always be given by a

doctor or nurse.

Many people who get meropenem in

hospital will have a drip (intravenous

line). Meropenem can be given

directly into the vein or the drip

without any need for an injection

through the skin. It is given either as

a slow injection over approximately

5 minutes or as a slow drip over 15 to

30 minutes.

Your doctor will decide which is best

for you.

How long will you be given

Your doctor will decide how many

days you will need to have

meropenem for.

If you take too much

(overdose)

If you think that you or anyone

else may have been given too much

of this medicine, immediately tell

your doctor or nurse.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are using

this medicine

Things you must do

Tell your doctor that you are using

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell your doctor if you develop

severe diarrhoea, even if it occurs

several weeks after you have been

given meropenem. It may mean that

you have a serious bowel condition

and you may need urgent medical

attention. Do not take any medicine

for your diarrhoea without checking

with your doctor first.

Your doctor may do tests to monitor

your liver function if you have pre-

existing liver disorders.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you are given this medicine.

Things to be careful of

Meropenem has been associated with

headache, tingling or prickling skin

and convulsions / seizures (fits). Any

of these could affect your ability to

drive or operate machines.

MEROPENEM IV APOTEX POWDER FOR INJECTION

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking meropenem or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

pain, swelling or redness around

the injection site

nausea and/or vomiting

diarrhoea

skin rash

itchiness

tingling, 'pins and needles'

sensation.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

severe diarrhoea, even if it occurs

several weeks after you have been

given meropenem

convulsions / seizures (fits)

unexpected breathlessness and/or

red/brown urine - this may

indicate damage to your red blood

cells.

Occasionally, meropenem may be

associated with changes in your

blood that may require your doctor to

do certain blood tests.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to meropenem, do

not take any more of this medicine

and tell your doctor immediately.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

The hospital staff will store

meropenem in a safe place at a

temperature below 25°C. They will

also check that the expiry date has

not passed.

Disposal

The hospital staff will dispose of any

unused meropenem.

Product description

What Meropenem IV

APOTEX powder for

injection or infusion looks

like

500mg: white to slightly yellow

powder in a 20 mL glass vial

1000mg: white to slightly yellow

powder in a 30 mL glass vial

Meropenem vials come in a pack size

of 10 vials.

* Not all strengths may be available.

Ingredients

Each vial contains 500 mg or

1000mg of meropenem (as

trihydrate) as the active ingredient.

It also contains sodium carbonate as

the inactive ingredient.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Meropenem IV APOTEX 500mg

powder for injection (20mL glass

vial) AUST R 218843.

Meropenem IV APOTEX 1000mg

powder for injection (30mL glass

vial) AUST R 218840

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

January 2015.

MEROPENEM IV APOTEX POWDER FOR INJECTION

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