Heparinum Vzf

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Heparinum WZF, 5,000 IU/ml, solution for injection

Heparinum natricum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or 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 to flush intravenous catheters and cannulas to ensure their patency before administering intravenous injections.

• in the treatment of thrombotic diseases: deep vein thrombosis, pulmonary artery embolism, unstable angina, acute peripheral arterial embolism;
• in procedures involving 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 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: peptic ulcer, tumor sites, hemorrhoids;
• if the patient has had intracranial bleeding, thrombosis of cerebral blood vessels, threatened abortion, bacterial endocarditis (the innermost layer of the heart), retinopathy;
• 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 surgery).

Warnings and precautions

Before starting treatment with Heparinum WZF, you should discuss it with your doctor.

• 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 medications, as heparin may increase potassium levels in the blood;
• if the patient has had a decrease in platelet count (when heparin is used for a long time);
• if the patient has severe kidney and/or liver function disorders;
• 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.

You should immediately tell your doctor if you experience symptoms such as:

• back pain, sensory, motor, or bowel/bladder function disorders after spinal or epidural anesthesia.

During long-term use of Heparinum WZF, your doctor may recommend monitoring your platelet count. If a decrease in platelet count is found, your doctor will recommend stopping heparin use.

Heparinum WZF and other medicines

You should tell your doctor about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.

• Heparinum WZF and other medicines used at the same time may affect each other's action, in particular the following medicines:
• acetylsalicylic acid, phenylbutazone, indomethacin (anti-inflammatory medicines);
• dipyridamole, antithrombin III (anticoagulant medicines);
• cefamandole, cefoperazone (antibiotics - medicines used in bacterial infections);
• dextran (used as a blood substitute);
• nitroglycerin, especially when administered intravenously (a medicine that dilates blood vessels, mainly veins);
• digitalis glycosides (used in heart diseases);
• tetracyclines (antibiotics - medicines used in bacterial infections);
• nicotine (found in tobacco);
• quinine (an antimalarial medicine);
• antiallergic medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.

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 in each milliliter, which corresponds to 45 mg/5 ml. Benzyl alcohol may cause allergic reactions.

3. How to use Heparinum WZF

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.

• 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.
• Your doctor will determine the dosage and 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, you should immediately consult your doctor.

Missing a dose of Heparinum WZF

You should not take a double dose to make up for a missed dose. Heparinum WZF should be used as directed by your doctor.

Stopping treatment with Heparinum WZF

Only your doctor can decide to stop treatment with Heparinum WZF.

4. Possible side effects

Like all medicines, Heparinum WZF can cause side effects, although not everybody gets them.

You should immediately tell your doctor:

• if bleeding occurs, which may indicate that you have received more medicine than necessary;
• if you experience the first symptoms of an allergic reaction (e.g. facial swelling, lip swelling, tongue swelling, throat swelling, causing difficulty breathing or swallowing, hives, itching, conjunctivitis). Such symptoms are rare after heparin use.

After intravenous administration, the following may occur:

• 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 (anaphylactic shock has been reported sporadically).
• Burning feet, tearing. Such symptoms have occurred rarely.
• Decreased platelet count (thrombocytopenia) - most often occurs between 6 and 12 days after starting treatment and is usually mild and asymptomatic. The platelet count usually returns to normal within 48-72 hours after stopping heparin use. However, it may recur with repeated heparin administration.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.

5. How to store Heparinum WZF

Store in a temperature below 25°C.

Medicines should be kept out of the sight and reach of children.

After the first dose has been taken, the vials should be stored in the refrigerator (2°C - 8°C) for no longer 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 month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

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.

Marketing authorization holder in Bulgaria, the country of export:

Warszawskie Zakłady Farmaceutyczne Polfa S.A.

Manufacturer:

Warszawskie Zakłady Farmaceutyczne Polfa S.A.

Parallel importer:

InPharm Sp. z o.o.

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

Marketing authorization number in Bulgaria, the country of export: 20011026

Parallel import authorization number: 49/23 Date of approval of the leaflet: 20.03.2023

[Information about the trademark]

Information intended only 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, and 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: "Method of administration of Heparinum WZF".
• Heparinum WZF can be diluted:
• 0.9% NaCl solution in a concentration range of 1 IU/ml to 1000 IU/ml,
• 5% glucose solution in a concentration range of 100 IU/ml to 1000 IU/ml.

Dosage

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

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: 1,000 to 2,000 IU/h in intravenous infusion or 5,000 to 10,000 IU in intravenous injections repeated every 4 hours.