Heparinum Vzf

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Heparinum WZF

5,000 IU/ml, solution for injection

Heparinum natricum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist, or nurse.
• This medicine has been prescribed specifically for a particular person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Heparinum WZF and what is it used for

Heparinum WZF contains unfractionated heparin, an anticoagulant substance. It reduces the blood's ability to clot, thereby preventing the formation of clots in blood vessels. Heparinum WZF can also be used for flushing intravenous catheters and cannulas to ensure their patency before administering intravenous injections.

• Heparinum WZF is used in the treatment of thrombotic diseases: deep vein thrombosis, pulmonary embolism, unstable angina, acute peripheral arterial thrombosis;
• in procedures performed in so-called extracorporeal circulation and hemodialysis (used to remove toxic substances from the blood in cases of severe kidney function disorders);
• in the diagnosis and treatment of acute and chronic coagulation disorders, such as, for example, disseminated intravascular coagulation;
• to flush intravenous catheters and cannulas to ensure their patency before administering intravenous injections.

2. Important information before using Heparinum WZF

When not to use Heparinum WZF:

• if the patient is allergic to heparin or benzyl alcohol, or any of the other ingredients of this medicine (listed in section 6).

For intravenous administration:

• if the patient has uncontrolled bleeding from sites such as, for example: peptic ulcer, areas affected by a tumor, hemorrhoids;

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• if the patient has had intracranial bleeding, thrombosis of cerebral blood vessels, threatened abortion, bacterial endocarditis (the innermost layer of the heart), retinal changes;
• if the patient has hemophilia, bleeding disorders (except for disseminated intravascular coagulation);
• if the patient has or has had a decreased platelet count;
• if the patient has severe liver disease;
• if the patient has purpura (skin changes in the form of single or merging bruises);
• if the patient has active tuberculosis;
• if the patient has severe hypertension;
• if the patient has increased capillary permeability, manifested by the formation of skin bruises and edema;
• if the patient has suffered extensive injuries;
• before ophthalmic and neurosurgical operations (brain operations).

Warnings and precautions

Before starting treatment with Heparinum WZF, it should be discussed with a doctor.
The doctor will exercise particular caution when using Heparinum WZF and will take appropriate action:

• if the patient has been found to be hypersensitive to low molecular weight heparins;
• if the patient has diabetes;
• if the patient has had metabolic acidosis (the appearance of acidic metabolic products in the blood, e.g. carbohydrates);
• if the patient has conditions that increase potassium levels in the blood or is taking potassium-sparing drugs, as heparin may increase potassium levels in the blood;
• if the patient has a decreased platelet count (when heparin is used for a long time);
• if the patient has severe kidney or liver dysfunction;
• if the patient is over 60 years old and is taking heparin for a long time, as there is a risk of bleeding complications;
• if the patient is elderly.

The patient should immediately tell their doctor if, after undergoing a procedure with spinal or epidural anesthesia, they experience symptoms such as: back pain, sensory disturbances, motor disturbances, disturbances of bowel or bladder function

(e.g. urinary incontinence).
During long-term use of Heparinum WZF, the doctor may recommend monitoring the platelet count. If a decrease in platelet count is found, the doctor will recommend discontinuing heparin use.
Precautions for use in flushing intravenous catheters and cannulas to ensure their patency:

• Caution should be exercised when using the medicine in patients with hypersensitivity to low molecular weight heparins.
• Aseptic techniques should be strictly followed when using.
• The doctor will recommend a blood test if the patient has been using Heparinum WZF to flush a catheter or cannula for more than five days. Repeated flushing with heparin may cause anticoagulant activity.

Heparinum WZF and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Heparinum WZF and other medicines used at the same time may affect each other's action, in particular, the following medicines.

• The anticoagulant effect of heparin is enhancedby:
• acetylsalicylic acid, phenylbutazone, indomethacin (anti-inflammatory drugs);
• dipyridamole, antithrombin III (anticoagulant drugs);
• cefamandole, cefoperazone (antibiotics - drugs used in bacterial infections);
• dextran (used as a blood substitute).
• The anticoagulant effect of heparin is weakenedby:
• nitroglycerin, especially when administered intravenously (a drug that dilates blood vessels, mainly veins);
• digitalis glycosides (used in heart diseases);
• tetracyclines (antibiotics - drugs used in bacterial infections);
• nicotine (found in tobacco);
• quinine (an antimalarial drug);
• antihistamines.
• The use of heparin and angiotensin-converting enzyme inhibitors (e.g. enalapril, captopril) may cause increased potassium levels in the blood.
• The use of heparin and thrombolytic drugs (which cause clot dissolution, e.g. streptokinase) increases the risk of bleeding complications.
• The concurrent administration of heparin and aprotinin (a drug that reduces bleeding) may cause prolonged bleeding time.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
The doctor may recommend the use of Heparinum WZF during pregnancy in strictly justified cases, after careful consideration of the risk and benefit to the woman. The medicine should be administered with particular caution in the third trimester of pregnancy and during the perinatal period due to the risk of bleeding.
If the patient is pregnant and plans to undergo epidural anesthesia during childbirth, they should not use heparin. They should discuss this with their doctor.
The safety of using Heparinum WZF for flushing intravenous catheters and cannulas in pregnant women has not been established, but it is not expected to pose a risk due to the small doses of heparin used for this purpose.
Heparin does not pass into breast milk.
See also below - "Heparinum WZF contains benzyl alcohol and sodium".

Driving and using machines

Heparinum WZF does not affect the ability to drive and use machines.

Heparinum WZF contains benzyl alcohol and sodium

The medicine contains 9 mg of benzyl alcohol per milliliter, which corresponds to 45 mg/5 ml. Benzyl alcohol may cause allergic reactions. The administration of benzyl alcohol to small children is associated with the risk of serious side effects, including respiratory disorders (so-called "gasping syndrome").
Do not administer to newborns (under 4 weeks of age) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's recommendation.
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Pregnant or breastfeeding women should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine contains 26.65 mg of sodium (the main component of table salt) per 5 ml, which corresponds to 1.33% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine can be diluted - see below: "Information intended exclusively for medical personnel". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used to dilute the medicine, you should consult the leaflet of the diluent used.

3. How to use Heparinum WZF

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the doctor should be consulted.

• Heparinum WZF is usually administered by medical personnel.
• The medicine is administered intravenously - by injection directly into a vein or by infusion.
• After dilution, the medicine can be used to flush intravenous catheters and cannulas to ensure their patency before administering intravenous injections.
• The doctor will determine the dosage of the medicine and the duration of treatment individually for each patient.

Using a higher dose of Heparinum WZF than recommended

A symptom of an overdose of Heparinum WZF is bleeding - if it occurs, the doctor should be consulted immediately.

Missing a dose of Heparinum WZF

A double dose should not be used to make up for a missed dose. Heparinum WZF should be used in accordance with the doctor's recommendation.

Stopping treatment with Heparinum WZF

The decision to stop treatment with Heparinum WZF will be made by the doctor.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.

The doctor should be told immediately:

• -if bleeding occurs, which may indicate that the patient has received more medicine than needed;
• -if the patient experiences the first symptoms of an allergic reaction (e.g. swelling of the face, lips, tongue, throat, causing difficulty breathing or swallowing, hives, itching, conjunctivitis). Such symptoms are rare after heparin administration.

The doctor will decide on further action.

After intravenous administration, the following may occur:
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• Skin and generalized hypersensitivity reactions (noted especially in people who have had allergic reactions to low molecular weight heparin in the past). These include: hives, conjunctivitis, rhinitis, asthma, cyanosis, dyspnea, feeling of threat, fever, chills, angioedema, and anaphylactic shock (rarely reported). See the information provided above.
• Burning of the feet, tearing. Such symptoms have occurred rarely.
• Decreased platelet count (thrombocytopenia) - most often occurs between the 6th and 12th day of treatment and is usually mild and asymptomatic. The platelet count usually returns to normal within 48-72 hours after discontinuing heparin use. However, it may recur when heparin is administered again. Severe cases have also been reported, so-called white clot syndrome, with symptoms such as skin necrosis or gangrene of the limbs.
• Deficiency of a hormone called aldosterone, which causes an increase in potassium levels in the blood and may occur after 5 to 27 days of heparin use. The increase in potassium levels is reversible and usually occurs in patients with diabetes or kidney failure.
• increased activity of liver enzymes (aminotransferases) and free fatty acid levels in serum - is asymptomatic and usually reversible.
• Osteoporosis - observed in women taking more than 10,000 IU per day for six months.
• Transient alopecia occurred after long-term heparin use, usually in high doses.

It is very unlikely that Heparinum WZF used to flush intravenous catheters and cannulas will have a systemic effect, due to the small concentration of heparin in the blood. However, rare cases of immunologically dependent thrombocytopenia and thrombosis have been reported in patients who have used heparin to flush catheters. Hypersensitivity reactions to heparin are rare, symptoms - see above.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be told. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Heparinum WZF

Store at a temperature below 25°C.
The medicine should be stored in a place that is invisible and inaccessible to children.
Note: after the first dose is taken, the vials should be stored in the refrigerator (2°C - 8°C) for no more than 3 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

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What Heparinum WZF contains

• The active substance of the medicine is sodium heparin. Each milliliter of the solution contains 5,000 IU of sodium heparin.
• The other ingredients are: sodium chloride, benzyl alcohol, sodium hydroxide 10% (to adjust pH), water for injections.

What Heparinum WZF looks like and what the packaging contains

Heparinum WZF is a colorless, light yellow or light green transparent liquid.
The packaging contains 10 vials of 5 ml each.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Warsaw Pharmaceutical Works Polfa S.A., ul. Karolkowa 22/24, 01-207 Warsaw

Manufacturer:

Warsaw Pharmaceutical Works Polfa S.A., ul. Karolkowa 22/24, 01-207 Warsaw

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20011026

Parallel import authorization number: 14/22 Date of leaflet approval: 11.01.2022

[Information about the trademark]
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Information intended exclusively for medical personnel:

Heparinum WZF

5,000 IU/ml, solution for injection

Heparinum natricum

Method of administration of Heparinum WZF

• Heparinum WZF is intended for intravenous administration in repeated injections or after prior dilution with 5% glucose solution or 0.9% NaCl solution in continuous infusion, as well as for use in flushing intravenous catheters and cannulas.
• Heparinum WZF for use in flushing intravenous catheters and cannulas should be diluted before use - see above, section: "Method of administration of Heparinum WZF".
• Heparinum WZF can be diluted:
• with 0.9% NaCl solution in a concentration range of 1 IU/ml to 1000 IU/ml,
• with 5% glucose solution in a concentration range of 100 IU/ml to 1000 IU/ml. Chemical and physical stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the diluted medicine should be used immediately. If it is not used immediately, the user is responsible for the conditions and storage time. If necessary, the prepared solution can be stored for a maximum of 24

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hours at a temperature below 25°C, provided that the dilution is prepared in controlled and validated aseptic conditions. The unused solution within 24 hours should be discarded.

• All operations related to diluting the medicine should be performed in controlled and validated aseptic conditions. Aseptic techniques should be observed for both Heparinum WZF and the equipment used during administration.
• After the first dose is taken, the vials should be stored in the refrigerator (2°C - 8°C) for no more than 3 days.
• The doses and infusion rate of the medicine should be determined individually based on the results of coagulation function tests - it is recommended to achieve 1.5-2.5 times the prolongation of activated partial thromboplastin time (APTT) compared to the average normal value or the value before treatment. The medicine is usually used for 7 to 10 days.
• Penicillin, tetracycline, erythromycin, gentamicin, kanamycin, colistin, novobiocin, vancomycin, chlordiazepoxide, hydroxyzine, prochlorperazine, hydrocortisone succinate, dobutamine hydrochloride, and morphine and its derivatives form insoluble complexes with heparin. Heparin and reteplase should not be combined in one solution.
• When a cannula is permanently attached and used for multiple blood sampling for laboratory analysis, the presence of heparin or saline may potentially disrupt or change the results of blood tests; before taking blood for analysis, the heparin solution in situshould be removed from the cannula by aspiration and discarded.

Dosage

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina, acute peripheral arterial thrombosis

Adults:
Initial dose: intravenously 5,000 IU (1 ml of solution), in severe pulmonary embolism the dose can be increased to 10,000 IU (2 ml of solution).
Maintenance doses: from 1,000 to 2,000 IU/h in intravenous infusion or from 5,000 to 10,000 IU in intravenous injections repeated every 4 hours.
Elderly patients:
It may be necessary to reduce the dose in elderly patients.
Children and adults with low body weight:
Initial dose: intravenously 50 IU/kg body weight.
Maintenance doses: from 15 to 25 IU/kg body weight/h in intravenous infusion or 100 IU/kg body weight in intravenous injections repeated every 4 hours.

Patients undergoing extracorporeal circulation and hemodialysis

Adults:
Extracorporeal circulation:
Initial dose: 300 IU/kg body weight, then we continue administration trying to maintain the activated clotting time (ACT) in the range of 400-500 seconds.
Hemodialysis:
Initial dose: from 1,000 to 5,000 IU.
Maintenance doses: from 1,000 to 2,000 IU/h to maintain the coagulation time above 40 minutes.
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To flush intravenous catheters and cannulas to ensure their patency before administering intravenous injections.

The medicine should be diluted before use - see above, section: "Method of administration of Heparinum WZF".
Usually, flushing should be performed using a dose of 200 IU of heparin (e.g. 2 ml of solution containing 100 IU/ml), once every 4 hours or as needed.
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