Heparinum Vzf

Leaflet attached to the packaging: patient information

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

Sodium heparin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 to flush intravenous catheters and cannulas to ensure their patency before administering intravenous injections.

Heparinum WZF is used:

• to treat thrombotic diseases: deep vein thrombosis, pulmonary embolism, unstable angina, acute peripheral arterial occlusions;
• in procedures involving extracorporeal circulation and hemodialysis (used to remove toxic substances from the blood in cases of severe kidney dysfunction);
• 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 a cerebral hemorrhage, thrombosis of cerebral 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 petechiae);
• 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 petechiae 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, the patient should discuss it with their doctor.

The doctor will exercise particular caution when using Heparinum WZF and will take appropriate action:

• if the patient has hypersensitivity 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 and/or liver dysfunction;
• if the patient is over 60 years old and is using 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 they experience symptoms such as back pain, sensory disturbances, motor disturbances, disturbances of bowel or bladder function after spinal or epidural anesthesia

(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:

It is recommended to use the medicine with caution in patients with hypersensitivity to low molecular weight heparins.

Aseptic principles must be strictly followed when using the medicine.

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 action.

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 anticoagulant action of heparin is enhancedby:
• acetylsalicylic acid, phenylbutazone, indomethacin (anti-inflammatory drugs);
• dipyridamole, antithrombin III (anticoagulant drugs);
• cefamandole, cefoperazone (antibiotics used in bacterial infections);
• dextran (used as a blood substitute).
• The anticoagulant action of heparin is weakenedby:
• nitroglycerin, especially when administered intravenously (a vasodilator, mainly venous);
• digitalis glycosides (used in heart diseases);
• tetracyclines (antibiotics used in bacterial infections);
• nicotine (found in tobacco);
• quinine (an antimalarial drug);
• antiallergic drugs.
• 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 using 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 in 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 unlikely that the doses of heparin used for this purpose would pose a risk.

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. Administration of benzyl alcohol to small children is associated with a risk of severe 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.

Pregnant or breastfeeding women should consult 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 consult 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 for dilution, refer to the leaflet of the diluent used.

3. How to use Heparinum WZF

This medicine should always be used as directed by the doctor. In case of doubts, consult the 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.
• The 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 overdose of Heparinum WZF is bleeding - if it occurs, the patient should immediately consult their doctor.

Missing a dose of Heparinum WZF

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

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, consult the doctor, pharmacist, or nurse.

4. Possible side effects

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

The patient should immediately tell their doctor:

• -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:

• 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).
• Burning of the feet, lacrimation. 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 with repeated heparin administration. Cases of severe thrombocytopenia have also been reported, 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 resolves after discontinuing the medicine, especially 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 low 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 side effects occur, including any not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Heparinum WZF

Store in a temperature below 25°C. Do not freeze.

The medicine should be stored out of sight and reach of children.

Note: after the first dose is taken, vials should be stored in the refrigerator for no longer than 3 days.

Do not use this medicine after the expiry date stated on the vial and carton. The expiry date refers to the last day of the given month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, pale yellow or pale green transparent liquid.

The packaging contains 10 vials of 5 ml each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Alfasigma S.p.A.

Via Enrico Fermi 1

65020 Alanno

Italy

Date of last update of the leaflet:

Information intended exclusively for medical personnel:

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

Sodium heparin

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:
• 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.

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 hours at 25°C, provided that the dilution is prepared in controlled and validated aseptic conditions. 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 principles should be observed for both Heparinum WZF and the equipment used during administration.
• After the first dose is taken, vials should be stored in the refrigerator for no longer than 3 days.
• Doses and infusion rates 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 pre-treatment value. The medicine is usually administered 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 inserted and used for multiple blood sampling for laboratory analysis, the presence of heparin or saline may potentially disrupt or alter blood test results; before blood sampling, 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 occlusions

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.

Elderly patients

In elderly patients, dose reduction may be required.

Children and adults with low body weight

Initial dose: intravenously 50 IU/kg body weight.

Maintenance doses: 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 administration is continued to maintain the activated clotting time (ACT) in the range of 400-500 seconds.

Hemodialysis:

Initial dose: 1,000 to 5,000 IU.

Maintenance doses: 1,000 to 2,000 IU/h to maintain the coagulation time above 40 minutes.

For flushing 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.