Label: information for the user

HEPARINA SODICA SALA 5.000 UI/ml injectable solution

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is Heparina sódica Sala 5.000 UI/ml and for what it is used

2.What you need to know before starting to use Heparina sódica Sala 5.000 UI/ml

3. How to use Heparina sódica Sala 5.000 UI/ml

4. Possible adverse effects

5. Storage of Heparina sódica Sala 5.000 UI/ml

6.Contents of the package and additional information

Sodium Heparin 5,000 UI/ml is a medication that contains sodium heparin as the active ingredient.

Sodium heparin belongs to the group of medications known as antithrombotics, which are used to prevent and treat the formation of blood clots (thrombi), it is an organic anticoagulant.

Under the prescription of a doctor, this medication 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 disseminated intravascular coagulation (DIC) thrombosis.

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

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

No use Heparina sódica Sala 5.000 UI/ml:

• If you are allergic to sodium heparin, heparin, porcine-derived substances, or any of the other components of this medication (listed in section 6);
• If you have a disease or condition that increases the risk of bleeding, such as a significant coagulation disorder, vascular fragility, or injuries that may bleed, such as active gastric or duodenal ulcers, cerebral hemorrhage, aneurysms, or brain tumors;
• If you have a severe liver or pancreas function disorder.
• If you have internal injuries that may bleed, such as active peptic ulcers, aneurysms (abnormal dilation or bulging of a portion of an artery), cerebral accidents, etc.;
• If you have a history or suspicion of a decrease in platelet count (thrombocytopenia);
• If you are to undergo surgery or have suffered damage to the central nervous system, eyes, or ears;
• If you have a heart infection called endocarditis;
• If you have a condition called Disseminated Intravascular Coagulation (DIC) due to a decrease in platelet count caused by heparin;
• If you have received heparin for treatment, it is contraindicated to use regional anesthesia in scheduled surgical interventions.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Heparina sódica 5.000 UI/ml.

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

It is essential to avoid intramuscular administration, due to the risk of local hematomas.

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

• If you suffer from a disease or injury that may bleed, such as uncontrolled high blood pressure, a history of gastric or duodenal ulcers, eye vascular disease (coroid or retina), kidney 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, which can occur if you have diabetes, chronic kidney disease, acidosis in the blood, or if you are taking medications that alter these levels, such as some diuretics. Your doctor may recommend a control of potassium levels.
• If you have or have had low platelet counts (thrombocytopenia). Your doctor may recommend a platelet count control.
• If you are to undergo a procedure with spinal or epidural anesthesia, or if you are to undergo a lumbar puncture;
• If you are administered in elderly patients, special caution should be taken, as with most medications;
• If you are administered in low-weight neonates, special caution should be taken due to the risk of cerebral bleeding.

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

Other Medications and Heparina Sódica Sala 5.000 UI/ml

Use of Heparina Sódica 5.000 UI/ml with other medications.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Precaution is recommended when administering heparin concomitantly with other anticoagulant medications, antiplatelet agents (ticlopidine), fibrinolytics, nonsteroidal anti-inflammatory drugs (NSAIDs, such as aspirin, paracetamol, or ibuprofen), glucocorticoids, dextranos, high doses of penicillin, and some cephalosporins (cefamandol, cefoperazona), some contrast media, and medications containing asparaginase, epoprostenol, or alprostadil.

Oral antidiabetic medications (sulfonilureas), medications used for anxiety treatment containing benzodiazepines (clordiazepóxido, 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 Lactation

Consult your doctor or pharmacist before using any medication.

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

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

Sodium heparin will be administered with caution and under continuous control, especially during the last trimester of pregnancy and interrupted 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

If this medication 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 renal insufficiency.

Driving and Operating Machinery

Sodium heparin does not affect the ability to drive vehicles or use hazardous or precision machinery.

Heparina Sódica Sala 5.000 UI/mlcontains 34 mg of sodium (main component of table salt/for cooking) 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 sensation of choking) because it contains “parahydroxybenzoate of propyl, sodium salt (E-217)” and “parahydroxybenzoate of methyl, sodium salt (E-219)”.

Sodium Heparin Solution 5,000 UI/ml should be administered by a healthcare professional.

The vials containing Sodium Heparin Solution 5,000 UI/ml are ready for immediate use via intravenous route. Do not administer via intramuscular route and avoid intramuscular injection of other agents due to the risk of hematoma formation during heparin sodium treatment. It can be used directly in the form of bolus or continuous infusion with a perfusion pump. Also, as subcutaneous injection. Your doctor will perform regular controls to monitor the doses. Follow the instructions unless your doctor has given you different instructions.

Your doctor will indicate the duration of your treatment with Sodium Heparin Solution 5,000 UI/ml. Do not discontinue treatment prematurely.

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

Adults:

Sodium Heparin can be administered via intravenous route (in continuous infusion or bolus), intraarterial, or subcutaneous route. Avoid intramuscular administration due to the risk of local hematomas.

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

Adults:

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

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

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

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 thromboembolic risk.

Unstable angina or acute myocardial infarction without thrombolytic therapy:

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

Acute myocardial infarction with thrombolytic therapy:

An initial intravenous bolus of 5,000 UI of heparin sodium followed by 24,000 UI/24h via continuous intravenous infusion adjusted according to aPTT is recommended.

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

Cardiac surgery:Heparinize the patient with 150-300 UI/kg, adjusting the dose according to coagulation tests to control anticoagulation levels.

Hemodialysis:An initial bolus of 1,000 UI will be administered in the arterial port of the hemodialysis circuit, followed by a perfusion in saline solution of 750-1,000 UI/h throughout the hemodialysis session.

Children:

The dose should be adjusted according to weight and required aPTT levels. In general, for anticoagulation, 80 UI/kg will be administered via bolus, followed by 18 UI/kg/h, adjusting the dose to maintain aPTT between 1.5 and 2.5 times the control value. Avoid high doses in low-weight neonates.

Older adults:

The dose should be adjusted according to weight and required aPTT levels.

Renal and hepatic insufficiency:

A lower dose may be necessary. The dose should be adjusted according to weight and required aPTT levels.

Pregnant women:

Prevention of venous thromboembolic disease:The administration of 5,000 UI subcutaneously every 8-12 hours is usually adequate in the first months of pregnancy, with doses of up to 10,000 UI every 12 hours possibly being necessary during the third trimester of pregnancy.

Careful monitoring according to aPTT is recommended.

Treatment of venous thromboembolic disease:The administration of heparin via bolus followed by continuous perfusion to maintain aPTT in the therapeutic range for at least 5 days and then subcutaneous doses every 12 hours adjusted to therapeutic aPTT values during the rest of pregnancy is recommended.

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

If you use more Sodium Heparin Solution 5,000 UI/ml than you should

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

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

If you forgot to useSodium Heparin Solution 5,000 UI/ml

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Frequent(in at least 1 in 10 patients):

Vascular disorders:bleeding and hematoma. It may also cause an increase in certain blood parameters (transaminases, gamma-GT, LDH, and lipases).

Skin and subcutaneous tissue disorders:erythema due to increased blood in the capillaries.

Rare(in at least 1 in 100 patients):

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

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

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

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

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

Reproductive and breast disorders:persistent penile erection.

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

If any other adverse reaction is observed that is not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly throughtheSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Once the vial is opened, administer the product immediately.

The stability of Sodium Heparin 1000 UI/ml and Sodium Heparin 5000 UI/ml mixtures at concentrations of 47.6 UI/ml and 455 UI/ml at 25°C ± 2°C for 72 hours with 5% glucose or 0.9% NaCl diluents has been confirmed.

Do not administer if the protective packaging is damaged or open. Only use if the solution appears transparent and free of visible particles.

Do not use this medication after the expiration date indicated on the packaging after cad. The expiration date is the last day of the month indicated. Medications should not be disposed of through drains or in the trash.

Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Heparin Sodium 5,000 UI/ml

- The active principle is heparin sodium (obtained from porcine intestinal mucosa). It is presented in the form of a solution for injection in vials of 5 ml. Each ml of solution contains 5,000 UI of heparin sodium (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 content of the container

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

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

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

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

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Reig Jofré, S.A. Laboratory

Gran Capitán, 10

08970 Sant Joan Despí

Barcelona

Last review date of this leaflet:03/2024.

Other sources of information

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

<---------------------------------------------------------------------------------------------------------------->

This information is intended solely for healthcare professionals:

Administration route

Subcutaneous route: administer preferably in the iliac crest or in the subdiaphragmatic abdominal fat pad, holding the application area with your fingers to form a fold that separates it from other deeper tissues and pressing the application area for 2 minutes after injection. It is recommended to rotate the area to avoid edema formation.