Siarhan protamini 1%

Package Leaflet: Information for the User

Protamine sulfate 1%,10 mg/ml, solution for injection
Protamini sulfas

Read the package leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, 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.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Protamine sulfate 1% and what is it used for
• 2. Important information before using Protamine sulfate 1%
• 3. How to use Protamine sulfate 1%
• 4. Possible side effects
• 5. How to store Protamine sulfate 1%
• 6. Contents of the pack and other information

1. What is Protamine sulfate 1% and what is it used for

Protamine sulfate 1% contains the active substance protamine sulfate. Protamine is a mixture of
low molecular weight, strongly basic peptides rich in arginine.
Protamine forms complexes with heparin, thereby neutralizing its anticoagulant effect.

Indications

Protamine sulfate 1% is used to counteract the anticoagulant effect of heparin.
After intravenous administration of the appropriate dose of protamine sulfate, neutralization of heparin's anticoagulant effect occurs within 5 minutes.

2. Important information before using Protamine sulfate 1%

When not to use Protamine sulfate 1%

Do not use in patients who have:

• hypersensitivity to protamine sulfate or any of the other ingredients of this medicine (listed in section 6);
• symptoms of intolerance after injection of the medicine;
• presence of antibodies against protamine in the blood serum;
• hypersensitivity to fish.

This medicine should not be used in patients with diabetes who have received or are receiving protamine-containing insulin products, due to the risk of acute adverse reactions, including anaphylactic reactions (severe allergic reactions).

Protamine sulfate 1% and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Protamine sulfate 1% is incompatible with some antibiotics, mainly penicillin and cephalosporin derivatives, amidotrizoic acid and ioxaglate and their derivatives used in diagnostics.

Pregnancy and breastfeeding

There are insufficient data on the use of Protamine sulfate 1% in pregnant and breastfeeding women.
The doctor should exercise caution when prescribing Protamine sulfate 1% to pregnant and breastfeeding women.

Driving and using machines

This does not apply, as patients receiving Protamine sulfate 1% are hospitalized after cardiovascular surgery.

3. How to use Protamine sulfate 1%

The use of the medicine is decided by the doctor.
The medicine is for use in a hospital setting.
Route of administration:intravenous.

Medicine for intravenous use only.

Protamine sulfate 1% administered by a route other than intravenous does not neutralize heparin.
Neutralization of heparin's anticoagulant effect should be carried out under close medical and laboratory control, especially the partial thromboplastin time (APTT) or coagulation time (ACT), in order to achieve a normal, physiological level of blood coagulation, i.e. blood clotting.
In case of doubt, consult your doctor again.

Usual doses

The dose of protamine sulfate depends on the time elapsed since intravenous administration of heparin and its amount.
It is assumed that 1 mg of protamine sulfate neutralizes the anticoagulant effect of approximately 100 IU of heparin. This neutralization usually occurs within 5 minutes after intravenous injection of protamine sulfate. Regardless of the route of heparin administration (intravenous, subcutaneous, intradermal), 5 ml (1 ampoule) of Protamine sulfate 1% is administered intravenously. If necessary, this procedure can be repeated once or several times at 10-15 minute intervals. Excessive excess of protamine sulfate may enhance anticoagulant effect.
After 3 hours of subcutaneous or intramuscular administration of heparin, when its prolonged anticoagulant effect occurs, the administration of protamine should be repeated.

Caution

Do not exceed the rate of administration of the medicine:
10 mg/ml should be administered no faster than 3 minutes,
50 mg/5 ml should be administered no faster than 10 minutes.

Too rapid administration of the medicine may cause intensification or occurrence of acute adverse reactions.

The medicine should be administered slowly: too rapid injection intensifies adverse reactions. It is recommended to administer the average dose of 50 mg over 10 minutes (no faster).
Intervals between subsequent doses of 50 mg of protamine sulfate in 5 ml should be from 10 to 15 minutes.
Additional doses should be calculated and administered based on the result of the patient's blood coagulation tests (APTT, ACT), which are recommended to be performed within 5 to 15 minutes after administration of Protamine sulfate 1%.

Use of a higher than recommended dose of Protamine sulfate 1%

In case of use of a higher than recommended dose of the medicine, immediately consult a doctor or pharmacist.

Missed administration of Protamine sulfate 1%

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

Discontinuation of Protamine sulfate 1%

In case of any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After administration of Protamine sulfate 1%, short-term and moderate side effects may occur, usually from the cardiovascular system:

• decrease in blood pressure; usually slight and transient;
• decrease in blood pressure with bradycardia (slow heart rate), usually slight and transient;
• transient slowing of heart rate;
• flushing, feeling of heat;
• transient circulatory disorders (hemodynamics).

Very rare: (occurring in less than 1 in 10,000)

Protamine sulfate, the size of which is determined based on the laboratory test of the patient's blood coagulation.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, phone and fax number of the above Department}
e-mail: adr@urpl.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Protamine sulfate 1%

Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Protamine sulfate 1% contains

• The active substance is protamine sulfate 10 mg/ml. 1 ampoule contains 50 mg of protamine sulfate.
• The excipient is water for injections.

What Protamine sulfate 1% looks like and contents of the pack

The medicine is a solution for injection.
5 ml glass ampoules containing the solution for injection, in a cardboard box.
The pack contains 1 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

BIOMED Serum and Vaccine Plant Ltd.
Chełmska 30/34 Street
00-725 Warsaw
phone: 22 841 40 71

Date of last revision of the leaflet: