1400 anti-heparin IU / ml (equivalent to 10 mg / ml) solution for injection and infusion
protamine sulphate
What Protamine Sulfate LEO Pharma is and what it is used for
The active ingredient is protamine sulfate which is used as anti- heparin to counteract the effects of heparin and low molecular weight heparins and reduce the effect of these substances in the body.
Heparin is used to prevent blood clots and can cause bleeding.
You may have been prescribed this medicine:
- to stop bleeding that has been caused by heparin / low molecular weight heparin
- to prevent bleeding if you have been treated with heparin / low molecular weight heparin and need to undergo surgery
- to cancel the effect of heparin used in certain types of heart surgery
What you need to know before you use Protamine Sulfate LEO Pharma
Do not use Protamine Sulfate LEO Pharma
- if you are allergic to protamine sulfate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Protamine Sulfate LEO Pharma.
- if you are diabetic and use insulin (especially protamine insulin)
- if you are allergic to fish
- if you are a man and are infertile (unable to have children) or if you have undergone vasectomy (surgery that makes the man sterile )
- if you have been previously treated with protamine sulfate, protamine insulin, or protamine chloride
If you have already received your injection, inform the hospital staff if any of the above apply to you. If you are not sure, talk to your doctor.
Children and young people
Protamine sulfate LEO Pharma is not intended for the treatment of children and adolescents.
Other medicines and Protamine sulfate LEO Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
There is no information on the use of this medicine in pregnant women. Protamine sulfate LEO Pharma should only be used during pregnancy if necessary.
Breast-feeding
If you are breastfeeding, talk to your doctor, nurse, or pharmacist before using this medicine.
There is no information on the use of this medicine in breastfeeding women.
If treatment with Protamine Sulfate LEO Pharma is necessary, breastfeeding should be discontinued during treatment.
Driving and using machines
Protamine sulfate LEO Pharma has no or negligible influence on the ability to drive and use machines.
Protamine sulfate LEO Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 5 ml, ie essentially ‘sodium-free’.
How to use Protamine Sulfate LEO Pharma
Your doctor will decide on the dose of Protamine Sulphate LEO Pharma you need. Dose one depends on the results of blood tests performed to determine which heparin dose to counteract. Protamine sulfate LEO Pharma is for intravenous use and can be given as a slow injection (for about 10 minutes) into a vein or by drip.
Dose one may need to be repeated, especially if low molecular weight heparin is to be counteracted, or if the operation will take a long time.
A maximum of 5 ml of this medicine will be given within 10 minutes.
If you use more Protamine Sulphate LEO Pharma than you should
This can affect the coagulation process by prolonging the time it takes for the blood to coagulate (clot).
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are :
If you get any of these side effects, talk to your doctor, nurse, or nearest hospital immediately.
- Severe allergic reaction. With symptoms such as severe breathing problems, wheezing or wheezing, swelling of the face and lips, heart problems, collapse (fainting due to low blood pressure )
- High blood pressure in the lungs. With symptoms such as severe breathing problems
- Severe and persistent low blood pressure. With symptoms such as slow heartbeat, bluish skin, fainting, or collapse (especially if Protamine Sulphate LEO Pharma was given too quickly)
The following minor side effects have been observed with Protamine Sulfate LEO Pharma:
- Low blood pressure. With symptoms such as dizziness
- Vomiting
- Back hurts
- Bleeding
- Allergic reaction, similar to hives or other rashes. With symptoms such as feeling hot, redness of the skin, shortness of breath, and swelling of the deeper layers of the skin (sometimes with swelling of the tongue and airways).
How to store Protamine Sulphate LEO Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Use immediately after opening the ampoule.
All remaining solutions must be discarded.
May only be used if the solution is clear and the ampoule is intact.
When the solution is diluted to be given as a slow infusion, the mixture should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is protamine sulfate. 1 ml contains 1400 anti- heparin IU protamine sulfate (equivalent to 10 mg), 5 ml contains 7000 anti- heparin IU protamine sulfate (equivalent to 50 mg)
- The other ingredients are: Sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections
What the medicine looks like and the contents of the pack
This medicine is supplied as a clear, colorless solution for injection and infusion in 5 ml ampoules.
Pack size: 5 or 50 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
LEO Pharma A / S,
Industriparken 55,
DK-2750 Ballerup,
Denmark.
Local representative :
LEO Pharma AB,
Box 404,
201 24 Malmö.
Tel. 040-35 22 00.
Manufacturer
CENEX SAS
52, rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France
Further information about this medicine is available on the Medical Products Agency’s website www.lakemedelsverket.se.