Heparin sodium Sala 1,000 IU/ml

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HEPARIN SODIUM SALA 1,000 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Heparina Sódica Sala 1,000 IU/ml is and what it is used for

Heparina Sódica Sala 1,000 IU/ml is a medicine containing sodium heparin as the active substance.

Sodium heparin belongs to a group of medicines called antithrombotics, that is, those used to prevent and treat the formation of blood clots (thrombi); it is an organic anticoagulant.

Under medical prescription, this medicine is indicated for:

• Prevention and treatment of venous thromboembolic disease: deep vein thrombosis and pulmonary embolism.
• Treatment of coronary artery 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.

Heparina Sódica Sala is indicated in the pediatric population from 28 days of age onwards, as well as in adults.

2. What you need to know before using Heparin Sodium Sala 1,000 IU/ml

Do not use Heparin Sodium Sala 1,000 IU/ml:

• If you are allergic to sodium heparin, heparin, substances of porcine origin, or to any of the other components of this medicine (listed in section 6);
• If you have a disease or condition that increases the risk of bleeding, such as a significant blood coagulation disorder, vascular fragility, or injuries that may bleed, such as active gastroduodenal ulcer, cerebral hemorrhage, aneurysms, or brain tumors;
• If you have a severe disorder affecting liver or pancreas function;
• If you have internal injuries prone to bleeding, such as active peptic ulcer, aneurysms (abnormal widening or bulging of a portion of an artery), stroke (interruption of blood supply to the brain), etc.;
• If you have a history of, or suspected low platelet count (thrombocytopenia);
• If you are scheduled for surgery or have sustained an injury to the central nervous system, eyes, or ears;
• If you have a heart infection called endocarditis;
• If you have a condition called Heparin-Induced Thrombocytopenia (HIT) leading to Disseminated Intravascular Coagulation (DIC);
• If you have previously received heparin for therapeutic purposes, regional anesthesia is contraindicated during scheduled surgical procedures.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Heparin Sodium 1,000 IU/ml.

Sodium heparin may be administered intravenously (continuous infusion or intermittent injection), intra-arterially, or subcutaneously (deep injection).

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

It is very important that you inform your doctor about all medical conditions you have had or currently have, in order to avoid the risk of bleeding, especially:

• If you have a disease or injury that could lead to bleeding, such as uncontrolled high blood pressure, history of gastroduodenal ulcer, ocular vascular disease (choroid or retina), kidney or urethral stones, or if you have recently undergone surgery;
• If you have liver or kidney disease;
• If you have high potassium levels in the blood, which may occur in patients with diabetes, chronic kidney disease, blood acidosis, or those taking medications that alter potassium levels, such as certain diuretics. Your doctor may recommend monitoring of potassium levels;
• If you have or have had low platelet counts (thrombocytopenia). Your doctor may recommend monitoring of platelet counts;
• If you are scheduled to undergo a procedure involving spinal or epidural anesthesia, or lumbar puncture;
• If the medicine is administered to elderly patients, special caution should be exercised, as is the case with most medications;
• If administered to low-birth-weight neonates, special caution is required due to the risk of cerebral hemorrhage.

If you are to undergo epidural or spinal anesthesia or a lumbar puncture, your doctor will perform a careful individual assessment of the benefit-risk ratio.

Other medicines and Heparin Sodium Sala 1,000 IU/ml

Using Heparin Sodium 1,000 IU/ml with other medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

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

Medications that increase serum potassium concentration 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. They will provide you with appropriate advice.

Intermittent intravenous injections of sodium heparin are not recommended during pregnancy.

Heparin should be administered with caution and under continuous monitoring, especially during the third trimester of pregnancy, and should be discontinued one or two days before the expected date of delivery due to the risk of fetal-maternal hemorrhage.

Sodium heparin is not excreted in breast milk.

Elderly patients

If this medicine is administered to elderly patients, there is an increased risk of bleeding (particularly in women), especially if the patient also has hepatic and/or renal insufficiency.

Driving and using machines

Sodium heparin does not affect the ability to drive or operate dangerous or precision machinery.

Heparin Sodium Sala 1,000 IU/ml contains less than 23 mg of sodium (1 mmol) per vial; hence, it is essentially “sodium-free”.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of suffocation), as it contains “sodium propyl parahydroxybenzoate (E-217)” and “sodium methyl parahydroxybenzoate (E-219)”.

3. How to use Heparin Sodium Sala 1.000 IU/ml

Heparin Sodium Sala 1.000 IU/ml must be administered by a healthcare professional.

Vials containing Heparin Sodium Sala 1.000 IU/ml are ready for immediate intravenous use. It must not be administered intramuscularly, and intramuscular injection of other agents should be avoided due to the risk of hematoma during treatment with sodium heparin. It can be used directly as a bolus or by continuous infusion via an infusion pump. It may also be administered as a subcutaneous injection. Your doctor will perform regular monitoring to control the dosage. Follow these instructions unless your doctor has given you different ones.

Your doctor will determine the duration of your treatment with Heparin Sodium Sala 1.000 IU/ml. Do not stop treatment prematurely.

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

Adults:

Sodium heparin may be administered intravenously (by continuous infusion or bolus), intra-arterially, or subcutaneously. Intramuscular administration should be avoided due to the risk of local hematomas.

The dose of heparin must be individualized and adjusted according to coagulation times. The recommended dose varies depending on the indication, as follows:

Adults:

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

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

For prevention of venous thromboembolic disease, 1,000 IU should be administered subcutaneously every 8–10 hours for 7 days or until the patient is ambulatory.

In surgical patients, the first injection should be given 1–2 hours before surgery.

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

Unstable angina or acute myocardial infarction without thrombolytic therapy:

An initial intravenous bolus of 1,000 IU of sodium heparin is recommended, followed by a continuous intravenous infusion of 32,000 IU/24 h adjusted according to aPTT.

Acute myocardial infarction with thrombolytic therapy:

An initial intravenous bolus of 1,000 IU of sodium heparin is recommended, followed by a continuous intravenous infusion of 24,000 IU/24 h 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, adjusting the dose based on coagulation tests performed to monitor anticoagulation levels.

Hemodialysis: Initially, 1,000 IU should be administered as a bolus into the arterial needle of the hemodialysis circuit, followed by a continuous infusion of 750–1,000 IU/h in saline solution throughout the hemodialysis session.

Children:

Dose adjustment according to weight and required aPTT levels is recommended. In general, for anticoagulation, 80 IU/kg as a bolus followed by 18 IU/kg/h is recommended, with dose adjustment to maintain an aPTT between 1.5 and 2.5 times the control value. High doses should be avoided in low-weight neonates.

Elderly:

Dose adjustment according to weight and required aPTT levels is recommended.

Renal and hepatic impairment:

A lower dose may be necessary. Dose adjustment according to weight and required aPTT levels is recommended.

Pregnant women:

Prevention of venous thromboembolic disease: Administration of 1,000 IU subcutaneously every 8–12 hours is usually adequate during the first months of pregnancy, although doses up to 10,000 IU every 12 hours may be required during the third trimester.

Careful monitoring according to aPTT is advised.

Treatment of venous thromboembolic disease: Intravenous bolus administration of heparin followed by continuous infusion to maintain aPTT within the therapeutic range for at least 5 days is recommended, followed by subcutaneous doses every 12 hours adjusted to therapeutic aPTT values for the remainder of the pregnancy.

Prophylaxis in pregnant women with heart valves: Subcutaneous administration of heparin every 12 hours at adjusted doses to maintain aPTT within the therapeutic range is recommended.

If you use more Heparin Sodium Sala 1.000 IU/ml than you should

You may experience some form of bleeding. In such a case, consult your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you. Bleeding can be reversed with 1% Protamine Sulfate.

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

If you forget to use Heparin Sodium Sala 1.000 IU/ml

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The possible adverse effects are listed below according to their frequency.

Frequent (at least 1 in 10 patients):

Vascular disorders: bleeding and bruising. In addition, an increase in certain blood parameters (transaminases, gamma-GT, LDH, and lipases) may occur.

Skin and subcutaneous tissue disorders: redness of the skin due to increased blood in the capillaries (Erythema).

Uncommon (at least 1 in 100 patients):

Blood and lymphatic system disorders: decreased platelet count, non-immune heparin-induced thrombocytopenia (type I). Also, prolonged activated partial thromboplastin time beyond the therapeutic range may occur.

Immune system disorders: allergic reactions, heparin-induced decrease in platelet count (type II), hypersensitivity.

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

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

Musculoskeletal and connective tissue disorders: osteoporosis (associated with long-term treatment).

Reproductive system and breast disorders: prolonged penile erection.

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

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

Reporting of adverse effects

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

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

5. Storage of HEPARIN SODIUM SALA 1,000 IU/ml

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

No special storage conditions are required.

Once the vial has been opened, administer the product immediately.

The stability of mixtures of Heparin Sodium 1,000 IU/ml and Heparin Sodium 5,000 IU/ml at concentrations of 47.6 IU/ml and 455 IU/ml has been demonstrated at 25°C ± 2°C for 72 hours when diluted with either 5% glucose or 0.9% NaCl.

Do not administer if the protective container is damaged or opened. Only use if the solution is clear and free from visible particles.

Do not use this medicine after the expiry date stated on the carton after "exp". The expiry date refers to the last day of the month indicated. Medicines must not be disposed of via wastewater or household waste.

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

6. Contents of the pack and other information

Composition of Heparin Sodium Sala 1.000 IU/ml

• The active substance is sodium heparin (obtained from porcine intestinal mucosa). It is presented as a solution for injection in 5 ml vials. Each ml of solution contains 1,000 IU of sodium heparin (equivalent to 10 mg).
• The other components (excipients) are 11.45 mg sodium methylparahydroxybenzoate (E-219), 1.12 mg sodium propylparahydroxybenzoate (E-217), sodium chloride, concentrated hydrochloric acid, sodium hydroxide and water for injections.

Appearance of the product and contents of the container

This medicine is supplied in a white type I glass vial with a capacity of 8 ml, closed with a chlorobutyl rubber stopper with a Teflon coating and an aluminum cap, with a white polypropylene coating for Heparin Sodium Sala 1.000 IU/ml and a blue coating for Heparin Sodium Sala 5.000 IU/ml. Inside there are 5 ml of a clear solution.

Each ml of the injectable solution contains 1,000 IU of sodium heparin.

Heparin Sodium Sala 1.000 IU/ml: pack containing 1, 50 and 100 vials with 5 ml of solution.

Heparin Sodium Sala 5.000 IU/ml: pack containing 1, 50 and 100 vials with 5 ml of solution.

Only some pack 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 most recent revision of this leaflet: 03/2024.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Method of administration

Deep subcutaneous route: administer preferably into the iliac crest or into the subcutaneous adipose tissue of the subdiaphragmatic abdominal region. Grasp the area of administration between the fingers to form a skin fold, separating it from deeper tissues. Apply pressure to the injection site for 2 minutes after injection. It is recommended to rotate injection sites to avoid the formation of edema.