NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PROTAMINE SULFATE®
Injection 1%
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about PROTAMINE SULFATE. 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 or pharmacist has weighed the risks of giving you PROTAMINE SULFATE 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 PROTAMINE SULFATE is used for
The active ingredient of PROTAMINE SULFATE is the protein protamine sulfate. Protamine sulfate is used in hospitals to counteract the effect of heparin given before and after surgery and after dialysis. Heparin is used to prevent blood clots from forming. Protamine sulfate is given when there is excessive bleeding from heparin administration.
Your doctor may have prescribed PROTAMINE SULFATE for another reason.Ask your doctor if you have any questions about why
PROTAMINE SULFATE has been prescribed for you.
This medicine is available only with a doctor’s prescription.
PROTAMINE SULFATE is not recommended for use in children.
Before you are given PROTAMINE SULFATE
When you must not be given it
You must not receive PROTAMINE SULFATE if you have a severe allergy to PROTAMINE SULFATE or an allergy to any of the ingredients listed at the end of this leaflet under Product Description.
Your doctor, nurse and pharmacist will ensure that you are not given PROTAMINE SULFATE after the expiry date (EXP) printed on the pack.
If you are given this medicine after the expiry date has passed, it may not work as well.
Your doctor, nurse and pharmacist will ensure that you are not given PROTAMINE SULFATE if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start being given PROTAMINE SULFATE, contact your doctor or pharmacist.
Before you are given it
Tell your doctor, nurse or pharmacist if you have allergies to:
any other medicines
any other substances, such as foods, in particular fish, preservatives or dyes
Tell your doctor, nurse or pharmacist if you are pregnant or intend to become pregnant.
Your doctor or pharmacist will discuss the possible risks and benefits of using PROTAMINE SULFATE during pregnancy.
Tell your doctor, nurse or pharmacist if you are breast-feeding or plan to breast-feed.
Your doctor or pharmacist will discuss the possible risks and benefits of using PROTAMINE SULFATE during breast-feeding.
Tell your doctor, nurse or pharmacist if you have or have had any medical conditions, especially the following:
Heart surgery
Diabetes and you have received protamine insulin
You are male and have had a vasectomy or are infertile.
Taking other medicines
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
How PROTAMINE SULFATE is given
PROTAMINE SULFATE is injected or infused into a blood vessel. The dose your doctor gives you of PROTAMINE SULFATE will depend on the amount of heparin that needs to be neutralised
While you are receiving PROTAMINE SULFATE
Things you must do
If you develop itching with swelling or skin rash, difficulty breathing, dizziness or abnormal heart beats while you are receiving PROTAMINE SULFATE tell your doctor or nurse immediately.
Side effects
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while receiving PROTAMINE SULFATE.
All medicines have side effects. Sometimes they may be serious, most of the time they are not. You may need urgent treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or nurse immediately if you notice any of the following:
Red or itchy skin with swelling, skin rash or difficulty breathing.
Tell your doctor or nurse if you notice any of the following and they worry you:
Abnormal heart beats
Dizziness
Flushing and/or a feeling of warmth
Back pain
Stomach disturbances
Weakness or generally feeling unwell
Other side effects not listed above may occur in some patients.Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by the list of possible side effects.
You may not experience any of them.
After using PROTAMINE SULFATE
Storage
PROTAMINE SULFATE should be stored in the pharmacy or on the ward.The injection should be kept where the temperature stays below 25°C.
Product description
What it looks like
A clear, colourless solution in a clear glass ampoule.
Ingredients
Each 5mL ampoule contains protamine sulfate 50mg, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Distributor
sanofi-aventis australia pty ltd
12-24 Talavera Road,
Macquarie Park, NSW 2113
Australia
Australian registration number:
AUST R 27971
This leaflet was prepared in May 2016.
protamine-ccsiv1-cmiv4-may16
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