2. What should I know before I am given INVANZ?
You should not be given INVANZ if you have ever had an allergic reaction to INVANZ
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with INVANZ and affect how it works.
4. How will I be given INVANZ?
INVANZ can be given in two ways:
as a slow injection into a vein, known as an intravenous infusion
as a deep injection into a large muscle, known as an intramuscular injection.
INVANZ must only be given by a doctor or nurse.
5. What should I know while being given INVANZ?
|
Things you should do
|
Call your doctor straight away if you:
Develop severe diarrhoea
Develop a severe skin reaction such as painful red areas, fluid filed bumps, large
blisters, or peeling layers of skin whilst being given INVANZ
|
|
Driving or using machines
|
INVANZ may cause dizziness or sleepiness in some patients. Make sure you know how
you react to INVANZ before you drive a car, operate machinery or do anything else
that could be dangerous if you are dizzy or sleepy.
|
|
Looking after your medicine
|
INVANZ will usually be stored in the pharmacy or on the ward.
The powder for injection should be kept in a cool dry place where the temperature
stays below 25°C.
|
6. Are there any side effects?
Common side effects of INVANZ include diarrhoea, inflammation of the vein, nausea,
and headache.
Active ingredient:
Ertapenem
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INVANZ. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using INVANZ.
Where to find information in this leaflet:
1. Why am I being given INVANZ?
INVANZ contains the active ingredient Ertapenem.
INVANZ belongs to a class of antibiotics called carbapenems. It works by killing the
bacteria causing your infection.
INVANZ is used to treat infections caused by bacteria (germs). These infections include:
- infections within the abdomen (stomach)
- pelvic infections
- diabetic foot infections in patients without osteomyelitis
INVANZ may also be used in patients not responding to, or unable to tolerate, other
antibiotics.
Your doctor may have prescribed INVANZ for another reason.
Ask your doctor if you have any questions about why INVANZ has been prescribed for
you.
2. What should I know before I am given INVANZ?
Warnings
INVANZ should not be given if:
you are allergic to Ertapenem, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
you have an allergy to other antibiotics in the same class as INVANZ
you have had a serious allergic reaction (anaphylaxis) to beta-lactam antibiotics,
including penicillins or cephalosporins
the vial cap shows signs of tampering
the expiry date printed on the pack has passed.
INVANZ should not be given by injection into a muscle if:
you have an allergy to amide-type local anaesthetics, particularly lidocaine
you are in severe shock
you have heart block
Check with your doctor if you:
have or have had any medical conditions, especially the following:
seizures or fits, or a predisposition to seizures (eg brain scarring)
kidney disease, or are undergoing dialysis
bowel problems while using antibiotics or after finishing them, including severe abdominal
or stomach cramps, or watery and severe diarrhoea
have allergies to other antibiotics, in particular penicillins and cephalosporins.
If you are allergic to any of them you may be allergic to INVANZ.
are pregnant or intend to become pregnant
are breast-feeding or intend to breast-feed
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes
are taking a medicine containing valproic acid
If you have not told your doctor about any of the above, tell them before you are
given INVANZ.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
Check with your doctor if you are pregnant or intend to become pregnant.
Like most medicines, INVANZ is generally not recommended during pregnancy. However,
if there is a need to consider using INVANZ during pregnancy, your doctor will discuss
the possible risks and benefits to you and your unborn baby.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Like most medicines, the use of INVANZ is generally not recommended while breast-feeding.
INVANZ is secreted into human milk.
Children
Do not use INVANZ in children under 3 months of age.
The safety and effectiveness in children younger than 3 months of age have not been
established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and INVANZ may interfere with each other. These include:
Sodium valproate, used to control different types of epilepsy and mania
These medicines may be affected by INVANZ, or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Your doctor will decide whether you should use INVANZ in combination with this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect INVANZ.
4. How will I be given INVANZ?
How is it given
INVANZ can be given in two ways:
as a slow injection into a vein, known as an intravenous infusion
as a deep injection into a large muscle, known as an intramuscular injection.
INVANZ will be prepared and given to you by a doctor or other healthcare professional.
When is it given
Your doctor will decide what dose and how long you will receive INVANZ. This depends
on your condition and other factors, such as your kidney function. No dose adjustment
is necessary if you are elderly.
If you are given too much INVANZ
As this product is administered by a doctor or healthcare professional, it is unlikely
you will be given too much INVANZ.
However, if you have any concerns you should immediately:
contact a healthcare professional, your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given INVANZ?
Things you should do
Call your doctor straight away if you:
Develop severe diarrhoea
Do this even if it occurs several weeks after INVANZ has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care.
This is because antibiotics such as INVANZ can change the type of bacteria in the
bowel. As a result, this allows bacteria, normally present in the bowel and normally
harmless, to multiply and cause the above symptoms.
Do not take any diarrhoea medicine without first checking with your doctor.
develop a severe skin reaction such as painful red areas, fluid filled bumps, large
blisters, or peeling layers of skin whilst being given INVANZ. You may need urgent
medical care.
Remind any doctor, dentist or pharmacist you visit that you are using INVANZ.
Driving or using machines
INVANZ may cause dizziness or sleepiness in some patients. Make sure you know how
you react to INVANZ before you drive a car, operate machinery or do anything else
that could be dangerous if you are dizzy or sleepy.
Looking after your medicine
It is unlikely that you will be asked to store INVANZ yourself. It will usually be
stored in the pharmacy or on the ward.
Getting rid of any unwanted medicine
A doctor, nurse or pharmacist will dispose of any unused INVANZ.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are not serious. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Common side effects
|
Common side effects
|
What to do
|
|
Tell your doctor or nurse if you notice any of the following and they worry you:
discomfort of the vein where you had the injection, for example pain, tenderness,
redness, swelling or firm swelling.
swelling, clotting, tenderness, swelling and inflammation
headache
nausea, vomiting
diarrhoea
vaginal itching or redness
alterations in some laboratory blood tests, and a combination of high fever, feeling
unwell, and skin rash
|
Speak to your doctor if you have any of these common side effects and they worry you.
|
These are the more common side effects of INVANZ. For the most part, these have been
mild.
Rare side effects
Very Rare side effects
If you have these, you may have had a serious allergic reaction to INVANZ. You may
need urgent medical attention. These side effects are very rare.
Rare side effects after finishing INVANZ
These are rare but serious side effects. You may have a serious condition affecting
your bowel.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What INVANZ contains
|
Active ingredient
(main ingredient)
|
ertapenem 1 g
|
|
Other ingredients
(inactive ingredients)
|
sodium bicarbonate
sodium hydroxide
|
Do not receive this medicine if you are allergic to any of these ingredients.
What INVANZ looks like
INVANZ is a white to off-white powder in a glass vial. (AUST R 81449).
Who distributes INVANZ
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113 Australia
This leaflet was prepared in September 2023
RCN: 000024561-AU, 000026129-AU
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.