Protamine sulfate 1%

Package leaflet: Information for the user

Protamine sulfate 1%, 10 mg/ml, solution for injection
Protamini sulfas
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Protamine sulfate 1% is and what it is 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 Protamine sulfate 1% is and what it is 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 reverse the anticoagulant effect of heparin.
After intravenous administration of an appropriate dose of protamine sulfate,
heparin's antithrombotic effect is neutralized within 5 minutes.

2. Important information before using the medicine Siarczan protaminy 1%

When not to use the medicine Siarczan protaminy 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);
• intolerance symptoms after injection of the medicine;
• presence of anti-protamine antibodies in blood serum;
• allergy to fish.

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

Siarczan protaminy 1% and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Siarczan protaminy 1% is incompatible with certain antibiotics, mainly penicillin derivatives and cephalosporins, with amidotrizoic acid and ioxaglic acid and their derivatives used in diagnostics.

Pregnancy and breastfeeding
There is insufficient data on the use of Siarczan protaminy 1% in pregnant and breastfeeding women.
The doctor should exercise caution when prescribing Siarczan protaminy 1% to pregnant women and those who are breastfeeding.

Driving and operating machinery
Not applicable, as patients receiving Siarczan protaminy 1% are hospitalized following cardiovascular surgery.

3. How to use the medicine Protamine sulfate 1%

The decision on use of the medicine is made by a physician.
The medicine is intended for use in inpatient care only.
Route of administration: intravenous.
The medicine is strictly for intravenous use only.
Protamine sulfate 1% administered by any route other than intravenous does not neutralize heparin.
Neutralization of heparin's anticoagulant effect should be carried out under strict medical and laboratory supervision, particularly monitoring activated partial thromboplastin time (APTT) or activated clotting time (ACT), in order to achieve normal, physiological blood coagulation capacity.
In case of doubt, consult the physician again.
Typical doses
The dose of protamine sulfate depends on the time elapsed since intravenous administration of heparin and the amount of heparin given.
It is generally accepted that 1 mg of protamine sulfate neutralizes the anticoagulant effect of approximately 100 IU of heparin. This neutralization typically occurs within 5 minutes after intravenous injection of protamine sulfate. Regardless of the route of heparin administration (intravenous, subcutaneous, or intradermal), 5 ml (1 ampoule) of Protamine sulfate 1% should be administered intravenously. If necessary, this procedure may be repeated once or several times at 10–15 minute intervals. An excessive surplus of protamine sulfate may enhance anticoagulant effects.
Three hours after subcutaneous or intramuscular administration of heparin, when prolonged anticoagulant action may occur, protamine administration should be repeated.
Warning
Do not exceed the recommended rate of administration:
10 mg/ml should be administered over no less than 3 minutes,
50 mg/5 ml should be administered over no less than 10 minutes.
Rapid administration of the medicine may intensify or cause acute adverse reactions.
The medicine should be administered slowly: rapid injection intensifies adverse reactions. Administration of the usual dose of 50 mg over 10 minutes (not faster) is recommended.
Intervals between consecutive doses of 50 mg protamine sulfate in 5 ml should be 10 to 15 minutes.
Additional doses should be calculated and administered according to the patient's blood coagulation test results (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 administration of a higher than recommended dose, seek immediate advice from a physician or pharmacist.
Missed dose of Protamine sulfate 1%
Do not administer a double dose to make up for a missed dose.
Discontinuation of Protamine sulfate 1%
If you have any further doubts regarding the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
After administration of Protamine sulfate 1%, transient and moderately severe adverse symptoms may occur, usually affecting the cardiovascular system:

• decrease in blood pressure; usually mild and transient;
• decrease in blood pressure with bradycardia (slow heart rate), mild and transient;
• transient slowing of heart rate;
• skin flushing, sensation of warmth;
• transient circulatory disturbances (hemodynamic disturbances).

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

protamine, the dose of which is determined based on the patient's blood coagulation laboratory test.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above-mentioned Department}
e-mail: [email protected] .
Reporting of adverse reactions enables continuous monitoring of the safety of the medicinal product.

5. How to store Siarczan protaminy 1%

Store below 25°C. Do not store in the refrigerator or freeze.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Siarczan protaminy 1% contains

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

What Siarczan protaminy 1% looks like and contents of the pack
The medicine is a solution for injection.
Glass ampoules containing 5 ml of solution for injection, packed in a cardboard box.
The pack contains 1 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIOMED S.A. Institute of Serums and Vaccines
ul. Chełmska 30/34
00-725 Warsaw
tel. 22 841 40 71