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Prosulf 10mg/ml Solution for Injection

Active Ingredient:
protamine sulfate
Company:  
Wockhardt UK Ltd See contact details
About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 21 Nov 2022
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0180.

{printer} Print patient leaflet as text only

Prosulf 10mg/ml Solution for Injection

Package leaflet: Information for the user

PROSULF® 10mg/ml Solution for Injection

(PROTAMINE SULFATE)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • This medicine has been prescribed for you only.
    Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Prosulf®10mg/ml Solution for Injection. In the rest of this leaflet, it is called Prosulf®.

What is in this leaflet

1. What Prosulf® is and what it is used for
2. What you need to know before you use Prosulf®
3. How to use Prosulf®
4. Possible side effects
5. How to store Prosulf®
6. Contents of the pack and other information

1. What Prosulf® is and what it is used for

The name of your medicine is Prosulf®. The active ingredient in Prosulf® is protamine sulfate.

Prosulf® contains protamine sulfate which is a heparin antidote which neutralises the anti blood-clotting effect of heparin and prevents it from thinning the blood too much.

It is used before surgery, after kidney dialysis, after open-heart surgery, if you bleed during heparin treatment or if too much heparin has been given to you by accident.

2. What you need to know before you use Prosulf®

Prosulf® should only be given as an antidote to heparin. It is not suitable for use as an antidote to other medicines that are used to thin the blood that are taken by mouth.

Do not use Prosulf®:
  • if you are allergic to protamine sulfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Prosulf® if you:

  • are allergic to fish, because you may also be allergic to Prosulf® as protamine sulfate comes from fish.
  • have ever had heart surgery
  • are an insulin dependent diabetic because Prosulf® may cause problems if you have previously used protamine insulin
  • are a man and you have had a vasectomy or are infertile.

If you are undergoing a long operation, where repeated doses of Prosulf® are necessary, you may occasionally experience bleeding up to 18 hours after your operation, which will stop when you are given further doses of Prosulf®.

If any of the above apply to you, speak to your doctor or nurse before Prosulf® is given to you.

Other medicines and Prosulf®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription.

Pregnancy and breast-feeding

You should let your doctor know if you are pregnant or breast-feeding before Prosulf® is administered.

Driving and using machines

Prosulf® has not been reported to affect ability to drive or operate machines.

Prosulf® contains sodium

This medicine contains less than 1 mmol sodium (23mg) per 10mg/ml, that is to say essentially ‘sodium- free’.

3. How to use Prosulf®

Do not use in children aged 12 years or younger.

  • Blood clotting tests should be carried out to check on the effects of Prosulf® to see if you need further doses.
  • Prosulf® should be given slowly by infusing into a vein over a period of about ten minutes.
  • The dose of Prosulf® you will be given depends on the amount and type of heparin to be neutralised, the way the heparin was given to you, and the amount of time that has passed since your last heparin injection.
  • No more than 50 milligrams protamine sulfate should be given to you in one dose. Your doctor will decide the dose that is best for you.

If you do not understand, or are in any doubt, ask your doctor or nurse.

If you forget to use Prosulf®

If you think that an injection has been missed, speak to your doctor or nurse.

Do not use a double dose to make up for a forgotten dose.

If you use more Prosulf® than you should

If you think you have been given too much Prosulf®, speak to your doctor or nurse. Signs of an overdose include hypotension (a lowering of blood pressure), an abnormally slow heart rate, a shortness of breath, excessive/ unexplained bleeding and/or bruising, feeling sick, being sick, a feeling of weakness or facial flushing and/or a feeling of warmth.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side-effects particularly when it is first given, although not everybody gets them.

These include:

  • slowing of the pulse
  • low blood pressure (you may feel dizzy or faint or you may black out)
  • high blood pressure
  • shortness of breath
  • flushing and a feeling of warmth in the body
  • back pain
  • feeling sick
  • being sick
  • tiredness.

Rarely, allergic reactions occur resulting in breathing difficulties or a rash. This can sometimes be more serious with fainting and collapse, swelling of the lips and face, and a blue discoloration of the lips and tongue. The doctor treating you will be ready to treat these effects if they occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Prosulf®

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. The expiry date refers to the last day of that month.

Do not use this medicine if it is discoloured or has gone cloudy.

The injection should be stored between 15°C and 25°C in the package or container in which it was dispensed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Prosulf® contains

The active ingredient in Prosulf® is protamine sulfate.

The injection comes in one strength of 10mg/ml.

Other ingredients in Prosulf® injection are sodium chloride, water for injections and trace amounts of hydrochloric acid and sodium hydroxide.

What Prosulf® looks like and contents of the pack

Prosulf® is a clear and colourless solution for injection. It is available in packs of 10 glass ampoules. Each ampoule contains 5ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Other formats

To listen to or request a copy of this information in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Prosulf® 10mg/ml Solution for Injection 29831/0180

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 09/2022.

105005/6

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
WWW
www.wockhardt.co.uk
Medical Information e-mail
[email protected]