SODIUM HEPARIN SALA 5000 IU/ml

Introduction

Package Leaflet: Information for the User

HEPARIN SODIUM SALA 5,000 IU/ml Solution for Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Heparin Sodium Sala 5,000 IU/ml is and what it is used for
2. What you need to know before you use Heparin Sodium Sala 5,000 IU/ml
3. How to use Heparin Sodium Sala 5,000 IU/ml
4. Possible side effects
5. Storage of Heparin Sodium Sala 5,000 IU/ml
6. Contents of the pack and other information

1. What Heparin Sodium Sala 5,000 IU/ml is and what it is used for

Heparin Sodium Sala 5,000 IU/ml is a medicine that contains heparin sodium as the active substance.

Heparin sodium belongs to a group of medicines called antithrombotics, which are used to prevent and treat the formation of blood clots (thrombi). It is an anticoagulant of organic origin.

Always under the prescription of a doctor, this medicine is indicated for:

- Prevention and treatment of venous thromboembolic disease: deep vein thrombosis and pulmonary embolism.

- Treatment of coronary disease: unstable angina and acute myocardial infarction.

- Treatment and prevention of peripheral arterial thromboembolism.

- Initial treatment of thrombosis in disseminated intravascular coagulation (DIC).

• Prevention of thrombosis in the extracorporeal circuit during cardiac and vascular surgery and hemodialysis.

Heparin Sodium Sala is indicated in pediatric population from 28 days of birth and in adults.

2. What you need to know before you use Heparin Sodium Sala 5,000 IU/ml

Do not use Heparin Sodium Sala 5,000 IU/ml:

• If you are allergic to heparin sodium, heparin, substances of porcine origin, or any of the other components of this medicine (listed in section 6);
• If you have a disease or condition that involves a risk of bleeding, such as a significant disorder of blood coagulation, vascular fragility, or injuries that may bleed, such as active gastroduodenal ulcer, cerebral hemorrhage, aneurysms, or brain tumors;
• If you have a severe disorder of liver or pancreatic function.
• If you have internal injuries that may bleed, such as active peptic ulcer, aneurysms (abnormal dilatation or bulging of a portion of an artery), stroke (interruption of blood supply to the brain), etc.;
• If you have a history or suspicion of a decrease in the number of platelets (thrombocytopenia);
• If you are going to undergo surgery or suffer any damage to the central nervous system, eyes, and ears;
• If you have an infection in the heart called endocarditis;
• If you have a disease called Disseminated Intravascular Coagulation (DIC) due to a decrease in the number of platelets produced by heparin;
• If you have received heparin for treatment purposes, it is contraindicated to use regional anesthesia in scheduled surgical interventions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Heparin Sodium 5,000 IU/ml.

Heparin sodium may be administered by intravenous route (continuous infusion or intermittent injection), intra-arterial, or subcutaneous route (deep injection).

Intramuscular administration should be avoided due to the risk of local hematomas.

It is very important that you inform your doctor of all the diseases you have had or are having, in order to avoid the risk of bleeding, and especially:

• If you suffer from a disease or injury that may bleed, such as uncontrolled arterial hypertension, history of gastroduodenal ulcer, in case of ocular vascular disease (choroid or retina), kidney or urethra stones, or if you have recently undergone surgery
• If you have liver or kidney disease.
• If you have high levels of potassium in the blood, as may occur if you have diabetes, chronic kidney disease, blood acidosis, or if you are taking medications that alter these levels, such as some diuretics. Your doctor may recommend monitoring your potassium levels.
• If you have or have had low platelet counts (thrombocytopenia). Your doctor may recommend monitoring your platelet count.
• If you are going to undergo a procedure with spinal or epidural anesthesia, or if you are going to undergo a lumbar puncture.
• If it is administered to elderly patients, special caution should be taken, as with most medications.
• If it is administered to low-weight neonates, special caution should be taken due to the risk of cerebral bleeding.

In case you are subjected to epidural or spinal anesthesia or a lumbar puncture, your doctor will perform an individual careful assessment of the benefit/risk ratio.

Other medicines and Heparin Sodium Sala 5,000 IU/ml

Use of Heparin Sodium 5,000 IU/ml with other medicines.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Caution is recommended when administering heparin concomitantly with other anticoagulant medications, antiplatelet agents (ticlopidine), fibrinolytics, non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin, paracetamol, or ibuprofen), glucocorticoids, dextran, high doses of penicillin, and some cephalosporins (cefamandole, cefoperazone), some contrast media, and medications containing asparaginase, epoprostenol, or alprostadil.

Oral antidiabetics (sulfonylureas), medications used to treat anxiety containing benzodiazepines (chlordiazepoxide, diazepam, oxazepam).

The anticoagulant effect of heparin may decrease in patients treated with intravenous nitroglycerin, and it may be necessary to adjust the heparin dosage.

Medications that increase serum potassium levels should only be taken under special medical supervision.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. He will give you the appropriate instructions.

Intravenous intermittent injections of heparin sodium are not recommended during pregnancy.

Heparin will be administered with caution and under continuous control, especially during the last trimester of pregnancy, and will be interrupted one or two days before the expected delivery date, given the risk of fetal-maternal bleeding.

Heparin sodium is not excreted in breast milk.

Elderly

If this medicine is administered to elderly patients, there is a higher risk of bleeding (especially in women), particularly if the patient also suffers from liver and/or kidney insufficiency.

Driving and using machines

Heparin sodium does not affect the ability to drive vehicles or use hazardous machinery or precision instruments.

Heparin Sodium Sala 5,000 IU/mlcontains 34 mg of sodium (main component of table salt/cooking salt) in each vial. This is equivalent to 1.7% of the maximum daily sodium intake recommended for an adult.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains "propyl parahydroxybenzoate, sodium salt (E-217)" and "methyl parahydroxybenzoate, sodium salt (E-219)".

3. How to use Heparin Sodium Sala 5,000 IU/ml

Heparin Sodium Sala 5,000 IU/ml should be administered by a healthcare professional.

The vials containing Heparin Sodium Sala 5,000 IU/ml are ready for immediate use by intravenous route. It should not be administered by intramuscular route, and intramuscular injection of other agents should be avoided due to the risk of local hematomas during heparin sodium treatment. It can be used directly as a bolus or in continuous infusion with a perfusion pump. It can also be used as a subcutaneous injection. Your doctor will perform regular checks to control the doses. Follow the instructions unless your doctor has given you different instructions.

Your doctor will indicate the duration of your treatment with Heparin Sodium Sala 5,000 IU/ml. Do not stop treatment prematurely.

The dose of heparin sodium should be individualized according to the patient's weight and clinical situation. It should also be adjusted according to the coagulation time or the activated partial thromboplastin time (APTT). The recommended dose varies depending on the following indications:

Adults:

Heparin sodium can be administered by intravenous route (in continuous infusion or bolus), intra-arterial, or subcutaneous route. Intramuscular administration should be avoided due to the risk of local hematomas.

The dose of heparin should be individualized and adjusted according to the coagulation times. The recommended dose varies depending on the different indications, being in each case the following:

Adults:

Treatment and prevention of venous thromboembolic disease: deep vein thrombosis, pulmonary embolism, and peripheral:

For treatment of venous thromboembolism, an initial intravenous bolus of 80 IU/kg of heparin sodium (or 5,000 IU regardless of weight) will be administered, which may be increased to 120 IU/kg (or 7,500 IU regardless of weight) in cases of severe pulmonary embolism. This initial dose will be continued with a maintenance dose, administered in continuous intravenous infusion, of 18 IU/kg (or 1,300 IU/h or 32,000 IU/24h, regardless of weight). Subsequently, the dose should be individualized and adjusted according to the activated partial thromboplastin time (APTT), which should be maintained in a range between 1.5 and 2.5 times the control value. Control should be performed 4-6 hours after starting the infusion and at similar intervals whenever it is necessary to vary the administered dose. A treatment duration of 5-10 days is recommended.

In the prevention of venous thromboembolic disease, 5,000 IU will be administered subcutaneously every 8-10 hours for 7 days or until the patient is ambulatory.

In surgical patients, the first injection will be administered 1-2 hours before the intervention.

In non-surgical patients, the treatment duration will coincide with the duration of the thromboembolic risk.

Unstable angina or acute myocardial infarction without thrombolytic therapy:

An initial intravenous bolus of 5,000 IU of heparin sodium is recommended, followed by 32,000 IU/24h in continuous intravenous infusion adjusted according to APTT.

Acute myocardial infarction with thrombolytic therapy:

An initial intravenous bolus of 5,000 IU of heparin sodium is recommended, followed by 24,000 IU/24h in continuous intravenous infusion adjusted according to APTT.

Treatment and prevention of thrombosis in the extracorporeal circulation circuit during cardiac surgery and hemodialysis:

Cardiac surgery:it is recommended to heparinize the patient with 150-300 IU/kg, varying the dose according to the coagulation tests performed to control the levels of anticoagulation.

Hemodialysis:initially, 1,000 IU will be administered in bolus, in the arterial button of the hemodialysis circuit, continuing with a perfusion in saline solution of 750-1,000 IU/h throughout the hemodialysis session.

Children:

The dose of heparin should be adjusted according to weight and the required APTT levels. In general, for anticoagulation, 80 IU/kg will be administered in bolus, followed by 18 IU/kg/h, adjusting the dose to maintain an APTT between 1.5 and 2.5 times the control value. High doses should be avoided in low-weight neonates.

Elderly:

The dose of heparin should be adjusted according to weight and the required APTT levels.

Kidney and liver insufficiency:

A lower dose may be necessary. The dose of heparin should be adjusted according to weight and the required APTT levels.

Pregnant women:

Prevention of venous thromboembolic disease:the administration of 5,000 IU subcutaneously every 8-12 hours is usually adequate in the first months of pregnancy, and doses of up to 10,000 IU every 12 hours may be necessary during the third trimester of pregnancy.

Careful monitoring is recommended according to APTT.

Treatment of venous thromboembolic disease:it is recommended to administer heparin in intravenous bolus followed by continuous infusion to maintain APTT levels in the therapeutic range for at least 5 days, and subsequently subcutaneous doses every 12 hours adjusted to therapeutic APTT values, throughout the remainder of pregnancy.

Prophylaxis in pregnant women with heart valves:it is recommended to administer subcutaneous heparin every 12 hours at doses adjusted to maintain APTT values in the therapeutic range.

If you use more Heparin Sodium Sala 5,000 IU/ml than you should

You may experience some type of bleeding. In this case, consult your doctor or go to the emergency department of the nearest hospital, accompanied by this leaflet. Bleeding can be reversed with 1% protamine sulfate.

In case of overdose or accidental administration, consult the Toxicology Information Service, telephone 91 562 04 20.

If you forget to use Heparin Sodium Sala 5,000 IU/ml

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects are listed below by frequency.

Common(at least 1 in 10 patients):

Vascular disorders:bleeding and hematoma. Additionally, an increase in the levels of certain blood parameters (transaminases, gamma-GT, LDH, and lipases) may occur.

Skin and subcutaneous tissue disorders:skin redness due to increased blood content in the capillaries (erythema)

Uncommon(at least 1 in 100 patients):

Blood and lymphatic system disorders:decrease in the number of platelets, including non-immune heparin-induced thrombocytopenia (type I). Additionally, the activated partial thromboplastin time may be prolonged beyond the therapeutic range.

Immune system disorders:allergic reactions, heparin-induced thrombocytopenia (type II), hypersensitivity.

Metabolism and nutrition disorders:excessive increase in potassium levels in the blood (hyperkalemia)

Skin and subcutaneous tissue disorders:skin necrosis, various types of rashes such as: erythematous, generalized, macular, maculopapular, papular, and pruritic, urticaria, pruritus, and hair loss (alopecia).

Musculoskeletal and connective tissue disorders:osteoporosis (related to long-term treatment)

Reproductive system and breast disorders:persistent erection of the penis.

General disorders and administration site conditions:reaction at the injection site.

If you observe any other adverse reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Heparin Sodium Sala 5,000 IU/ml

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Once the vial is opened, the product should be administered immediately.

The stability of the mixtures of Heparin Sodium 1,000 IU/ml and Heparin Sodium 5,000 IU/ml at a concentration of 47.6 IU/ml and 455 IU/ml at 25°C ± 2°C for 72 hours with the diluents glucose 5% or NaCl 0.9% has been verified.

Do not administer if the protective packaging is damaged or open. It will only be used if the solution is transparent, free of visible particles.

Do not use this medicine after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Composition of Sodium Heparin Sala 5,000 UI/ml

• The active ingredient is sodium heparin (obtained from porcine intestinal mucosa). It is presented in the form of a solution for injection in 5 ml vials. Each ml of solution contains 5,000 UI of sodium heparin (equivalent to 50 mg).
• The other components (excipients) are 11.45 mg methylparahydroxybenzoate sodium (E-219), 1.12 mg propylparahydroxybenzoate sodium (E-217), sodium chloride, concentrated hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Container Content

This medication is presented in a type I white glass vial with a capacity of 8 ml, closed with a chlorobutyl stopper with Teflon and an aluminum cap, with a polypropylene coating, white for Sodium Heparin Sala 1,000 UI/ml and blue for Sodium Heparin Sala 5,000 UI/ml. Inside, it contains 5 ml of a transparent solution.

Each ml of the injectable solution contains 5,000 UI of sodium heparin.

Sodium Heparin Sala 1,000 UI/ml: container containing 1, 50, and 100 vials with 5 ml of solution.

Sodium Heparin Sala 5,000 UI/ml: container containing 1, 50, and 100 vials with 5 ml of solution.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí

Barcelona

Date of the Last Revision of this Prospectus:03/2024.

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Method of Use

Deep subcutaneous route: administer preferably in the iliac crest or in the fatty panicle of the subdiaphragmatic abdominal region, holding the application area with the fingers to form a fold that separates it from other deeper tissues and pressing the application site for 2 minutes after injection. It is recommended to rotate the area to avoid the formation of edemas.