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PROTAMINE SULPHATE INJECTION BP

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Patient Information Leaflet: Protamine Sulphate Injection BP, 10 mg/ml
Solution for Injection Protamine sulphate

Read all of this leaflet carefully before you are given this
medicine.
• 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. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
• In this leaflet, Protamine Sulphate Injection BP 10
mg/ml Solution for Injection will be called Protamine
Sulphate.

1. What Protamine Sulphate is for

In this leaflet:
1. What Protamine Sulphate is for
2. Before you are given Protamine Sulphate
3. How Protamine Sulphate will be given to you
4. Possible side effects
5. How to store Protamine Sulphate
6. Further information.

2. Before you are given Protamine Sulphate

Protamine Sulphate belongs to a group of medicines
known as anti-haemorrhagics (drugs that stop bleeding).
Protamine Sulphate stops the effect of a medicine called
heparin by binding to it in the blood. Heparin is a
medicine that prevents unwanted blood clots. However, if
too much heparin is given, the blood will not clot, even
when it needs to (for example, if you cut yourself) and
excessive bleeding and bruising can occur.
Protamine sulphate is used to reverse the effects of
heparin when too much has been given.

You must not be given Protamine Sulphate Injection if:
• You are allergic to the active ingredient Protamine Sulphate
• You are allergic to any of the other ingredients of
Protamine Sulphate (listed in section 6).
If any of the above applies to you, you must not be given
this medicine, talk to your doctor or nurse.
Check with your doctor before you are given Protamine
Sulphate if:
• You are diabetic and using insulin
• You are allergic to fish
• You have had this medicine before
• You have recently had heart surgery
• You need to have kidney dialysis
• You are male and have had a vasectomy or are infertile
(unable to father children).
If any of the above applies to you, talk to your doctor or nurse.

Tell your doctor if you are taking any of the following
medicines:
• Tablets or other oral medicines (taken by the mouth) to
thin your blood
• Any antibiotics
• Any other medicine, including medicines obtained
without a prescription.
Tell your doctor if you are having blood tests to measure
the level of catecholamines (e.g adrenaline) in your blood.
Protamine Sulphate can affect the accuracy of these tests.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or
breastfeeding ask your doctor or nurse for advice before
you are given Protamine Sulphate.
Warnings about the ingredients in Protamine Sulphate
This medicinal product contains less than 1 mmol sodium
per dose, in other words, it is essentially ‘sodium-free’.

3. How Protamine Sulphate will be given to you
Important: Protamine Sulphate will be given to you by a
doctor or nurse in hospital. Your doctor will choose the
dose that is right for you.
Adults, the elderly and children
Protamine Sulphate is given by a slow injection into a
vein over about 10 minutes. Sometimes this is followed
by an intravenous infusion (a drip into a vein), or
separate injections every 2 hours, for up to 16 hours.
The dose of Protamine Sulphate you will be given is
between 0.25 – 1.5 mg per 100 International Units of
heparin you have received. The exact dose you need
depends on:
• Whether you have been given standard or what is
called ‘low molecular weight’ heparin
• How much heparin you have been given
• The type of injection used to give the heparin to you,
e.g. intravenous injection (into a vein), intravenous
infusion (a drip into a vein) or subcutaneous injection
(under the skin)
• How long ago you were given Heparin.
Your doctor or nurse will not give you more than 50 mg
of Protamine Sulphate over a 10-minute period.
Medical check-ups
While you are taking this medicine, your doctor may
check how well your blood can clot. These tests are to
make sure that your medicine is working properly and
that the dose you are taking is right for you.

If you think you may have been given too much
Protamine Sulphate
As this medicine will be given to you by a doctor or
nurse, it is unlikely that you will be given too little or too
much. However, tell your doctor or nurse if you have any
concerns.
An overdose of Protamine Sulphate may cause bleeding.
If you have any further questions about the use of this
medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines Protamine Sulphate can cause side
effects, although not everybody gets them.
Seek immediate medical help if you have any of the
following rare symptoms:
• Swelling of hands, feet, lips, mouth, tongue or throat
• Breathing difficulties
• Itchy skin rash
• Diarrhoea or stomach pains
• Feeling faint or unconsciousness.
These are the signs of a severe and sometimes lifethreatening allergic reaction.

Other side effects are:
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension)
• Being sick, feeling sick and tiredness
• A feeling of warmth
• Flushing of the skin (warmth and redness of the skin).
• Patients undergoing heart surgery or stent implantation
may suffer from blood clots.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or nurse.

6. Further information

5. How to store Protamine Sulphate

Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervägen 7, 136 50
Haninge, Sweden.

Keep out of the reach and sight of children.
Do not use Protamine Sulphate after the expiry date on
the label. The expiry date refers to the last day of that
month.
Store below 25ºC.
Your doctor or nurse will make sure your medicine is
correctly stored and disposed of.

What Protamine Sulphate Injection BP contains
The active substance is protamine sulphate. Each 1 ml of
solution contains 10 mg of protamine sulphate.
The other ingredients are sulphuric acid (E513), sodium
hydroxide (E524) and water for injections.
What Protamine Sulphate looks like
Protamine Sulphate Injection is a sterile solution for
injection and comes in 5 ml neutral glass containers
(ampoules) in packs of ten.

Manufacturer
Recipharm Ltd
Vale of Bardsley
Ashton-under-Lyne
OL7 9RR
UK.
This leaflet was last updated March 2010.

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact:
RPH Pharmaceuticals AB,
Lagervägen 7, 136 50 Haninge,
Sweden.

P1200D Protamine

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P1200D Protamine Sulphate
TECHNICAL SUPPORT APPROVAL
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POSITION
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REGULATORY APPROVAL*
SIGNATURE
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*AUTHORISED TO PRINT COMPONENT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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