Heparin sodium Rovi 5000 IU/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Heparina sódica ROVI 5,000 IU/ml solution for injection

Sodium heparin

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Heparina sódica ROVI 5,000 IU/ml solution for injection is and what it is used for
2. What you need to know before using Heparina sódica ROVI 5,000 IU/ml solution for injection
3. How to use Heparina sódica ROVI 5,000 IU/ml solution for injection
4. Possible adverse effects
5. Storage of Heparina sódica ROVI 5,000 IU/ml solution for injection
6. Contents of the pack and other information

1. What Heparina sódica ROVI 5,000 IU/ml injection solution is and what it is used for

Heparin sodium belongs to a group of medicines called antithrombotics, that is, those used to prevent and treat the formation of blood clots (thrombi).

This medicine is available as an injectable solution, with a concentration of sodium heparin 5,000 IU/ml, in 5 ml vials.

This medicine is indicated for:

• Treatment and prevention of venous thromboembolic disease: deep vein thrombosis, pulmonary embolism.
• Treatment and prevention of peripheral arterial thromboembolism.
• Treatment of coronary artery disease: unstable angina and acute myocardial infarction.
• Prevention of thrombosis in the extracorporeal circuit during cardiac and vascular surgery and hemodialysis.

Heparina sódica ROVI is indicated in pediatric patients from 28 days of age and in adults (see section 2).

2. What you need to know before using Heparina sódica ROVI 5,000 IU/ml solution for injection

Do not use Heparina sódica ROVI 5,000 IU/ml solution for injection

• If you are allergic to sodium heparin, substances of porcine origin, or any of the other ingredients of this medicine (listed in section 6).
• If you have a history of, or suspect, a decrease in platelet count (thrombocytopenia).
• If you have a disease or condition that carries a risk of bleeding, such as a significant blood coagulation disorder, vascular fragility, or lesions that may bleed, including active gastroduodenal ulcer, cerebral hemorrhage, aneurysms, or brain tumors.
• If you have a severe disorder affecting liver or pancreatic function.
• If you are scheduled for surgery or have an injury affecting the central nervous system, eyes, or ears.
• If you have a heart infection called acute bacterial endocarditis.
• If you have a condition known as Heparin-Induced Thrombocytopenia (HIT) leading to Disseminated Intravascular Coagulation (DIC).
• If you have received heparin for therapeutic purposes, the use of regional anesthesia is contraindicated during scheduled surgical procedures.
• In premature infants and newborns, due to the presence of benzyl alcohol in this medicine.
• If you are actively bleeding or have a high risk of bleeding due to impaired blood clotting.

Warnings and precautions

Talk to your doctor or pharmacist before using Heparina sódica ROVI 5,000 IU/ml solution for injection

• If you have a disease or injury that may cause 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 elevated potassium levels in the blood, which may occur in conditions such as diabetes, chronic kidney disease, blood acidosis, or when taking medications that affect 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 a lumbar puncture.
• If skin necrosis occurs at the injection site when administered subcutaneously.
• If administered to elderly patients, special caution is required due to increased risk of bleeding.
• If administered to low-birth-weight neonates, special caution is required due to the risk of intracranial hemorrhage.
• If administered to women who are breastfeeding, special caution is required due to the risk of bone-related abnormalities.
• If you are receiving other medications via intramuscular injection, due to the risk of hematomas during heparin administration.

Other medicines and Heparina sódica ROVI 5,000 IU/ml solution for injection

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

It is especially important to inform your doctor if you are taking any of the following medicines:

• Anticoagulants, antiplatelet agents (ticlopidine), fibrinolytics, non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, paracetamol, or ibuprofen, glucocorticoids, dextran, high doses of penicillin, and certain cephalosporins (cefamandole, cefoperazone), some contrast media, asparaginase, and epoprostenol, as these drugs enhance the effect of heparin and thereby increase the risk of bleeding.

• Alprostadil, as it may potentiate the anticoagulant effect of heparin and increase the risk of hemorrhage, and may also interfere with laboratory test results.

• Oral antidiabetic agents (sulfonylureas), medications containing benzodiazepines (chlordiazepoxide, diazepam, oxazepam), or propranolol, as their effects may be enhanced in the presence of heparin.

• Intravenous epoetin or nitroglycerin, as they may reduce the anticoagulant effect of heparin, and dose adjustment may be necessary.

• Medications that increase blood potassium concentration.

Pregnancy and breastfeeding

Pregnancy:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 feto-maternal hemorrhage.

Breastfeeding:

Before starting treatment with Heparina sódica ROVI 5,000 IU/ml solution for injection, inform your doctor if you are breastfeeding. Sodium heparin ROVI 5,000 IU/ml solution for injection is not excreted in breast milk.

Use in the elderly

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 impairment.

Driving and using machines

Heparina sódica ROVI 5,000 IU/ml solution for injection does not affect the ability to drive vehicles or operate dangerous or precision machinery.

Heparina sódica ROVI 5,000 IU/ml solution for injection contains benzyl alcohol

This medicine must not be administered to premature infants or newborns because it contains 10 mg/ml of benzyl alcohol. It may cause toxic and allergic reactions in children under 3 years of age.

3. How to use Heparin sodium 5,000 IU/ml injection solution

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The vials containing Heparin sodium ROVI 5,000 IU/ml injection solution are ready for immediate use by intravenous route (continuous infusion via infusion pump or as a bolus), intra-arterial, or subcutaneous administration. It must not be administered by intramuscular route, and intramuscular injection of other agents should be avoided due to the risk of hematoma development during treatment with sodium heparin.

Your doctor will perform regular monitoring to control the dosage. Follow the instructions unless your doctor has given you different directions.

Your doctor will determine the duration of your treatment with Heparin sodium ROVI 5,000 IU/ml injection solution. 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 doses to be used for different populations are detailed in the section intended exclusively for healthcare professionals at the end of this leaflet.

Adults:

Your doctor will adjust the dose according to coagulation times.

Pediatric population:

Children from 28 days of age

The doctor will adjust the dose according to weight and required APTT levels.

Elderly patients:

Your doctor will adjust the dose according to weight and required APTT levels.

Patients with renal and hepatic impairment:

A lower dose may be required. Your doctor will adjust the dose according to weight and required APTT levels.

Pregnant women:

Your doctor will adjust the dose according to required APTT levels.

Instructions for correct administration of the medicinal product:

Deep subcutaneous route:

Grasp a skin fold gently, without pressing, between the thumb and index finger of one hand. While maintaining this skin fold, insert the needle perpendicularly to the skin fold with the other hand—that is, at a right angle to the skin. Carefully insert the needle and slowly inject the required dose into the fatty tissue beneath the skin. Remove the needle after injection and press the injection site for several minutes. Rotation of injection sites is recommended to avoid the formation of edema.

If you use more Heparin sodium ROVI 5,000 IU/ml injection solution than you should

You may experience some type of bleeding. In such a case, contact 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. Telephone: 91 562 04 20.

If you forget to use Heparin sodium ROVI 5,000 IU/ml injection solution

Do not administer a double dose to make up for the missed dose. Consult your doctor as soon as possible to determine what you should do in such cases.

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 may cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed:

Frequent effects (may affect between 1 and 10 in every 100 patients):

• Bleeding complications, especially when high doses are administered. If you notice nosebleeds, blood in your urine or stool, or any other type of bleeding, 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.
• Abnormal liver function test results (increased serum levels of hepatic transaminases).

Uncommon effects (may affect between 1 and 10 in every 1,000 patients):

• Allergic skin reactions (redness, itching).
• Hair loss (alopecia) during long-term treatment.
• Osteoporosis.
• Decreased number of platelets in the blood (thrombocytopenia).
• Increased serum potassium levels in patients with kidney disease or diabetes.
• Suppression of aldosterone synthesis (hyperkalemia).

Rare effects (may affect between 1 and 10 in every 10,000 patients):

• Skin degeneration at the injection site when administered subcutaneously.
• Severe generalized allergic reactions (nausea, vomiting, fever, breathing difficulties, bronchospasm, throat swelling, decreased blood pressure).
• Prolonged penile erection (priapism).
• Severe immune-mediated decrease in blood platelets (type II thrombocytopenia).

Very rare effects (may affect fewer than 1 in every 10,000 patients):

• Very rarely, if you are treated with anticoagulant medicines and undergo epidural or spinal anaesthesia, bleeding may occur in the spinal canal. This may damage nerves, resulting in loss of strength or sensation in the legs or lower half of the body.

If this occurs, stop treatment immediately and consult your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

Effects with unknown frequency:

• Red, irregular skin lesions with blisters.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to 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 ROVI 5,000 IU/ml solution for injection

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

Do not store above 30°C.

After opening the vial, administer the product immediately.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Heparin Sódica ROVI 5,000 IU/ml injectable solution

• The active substance is sodium heparin.
• The other components are sodium chloride, benzyl alcohol (10 mg/ml), sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the container

Colourless, clear solution, free from visible particles.

Packaging with 1 or 50 vials of 5 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS FARMACÉUTICOS ROVI, S.A.
Julián Camarillo, 35
28037-Madrid
Spain

Manufacturer

ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Julián Camarillo, 35
28037-Madrid
Spain

LABORATORIOS FARMACÉUTICOS ROVI, S.A.
Julián Camarillo, 35
28037-Madrid
Spain

Date of the most recent review of this leaflet: October 2025

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

This information is intended for healthcare professionals only:

The recommended dose varies depending on the different indications, as follows:

Adults:

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

An initial intravenous bolus of 80 IU/kg of sodium heparin should be administered, which may be increased up to 120 IU/kg 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. Subsequently, the dose should be individualized and adjusted according to the activated partial thromboplastin time (aPTT), which should be maintained within a range of 1.5 to 2.5 times the control value. Monitoring should be performed 4–6 hours after starting the infusion and at similar intervals whenever a dose adjustment is required. A treatment duration of 5–10 days is recommended.

For prevention of venous thromboembolic disease, 5,000 IU administered subcutaneously every 8–10 hours for 7 days or until the patient is ambulatory is recommended.

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

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

Unstable angina or acute myocardial infarction without thrombolytic therapy:

An initial intravenous bolus of 5,000 IU of sodium heparin is recommended, followed by 32,000 IU/24 hours as a continuous intravenous infusion adjusted according to aPTT.

Acute myocardial infarction following thrombolytic therapy:

An initial intravenous bolus of 5,000 IU of sodium heparin is recommended, followed by 24,000 IU/24 hours as a continuous intravenous infusion adjusted according to aPTT.

Prevention of thrombosis in the extracorporeal circuit during cardiac surgery and hemodialysis:

Cardiac surgery: Heparinization with 150–300 IU/kg is recommended, with dose adjustments based on coagulation tests performed to monitor anticoagulation levels.

Hemodialysis: Prior to starting dialysis, a bolus injection of 25–30 IU/kg is administered, followed by a continuous infusion of 1,500–2,000 IU per hour throughout the hemodialysis session. Heparin infusion should be stopped approximately 30 minutes before the end of dialysis to allow hemostasis recovery before catheter removal.

Pediatric population:

Children from 28 days of age: 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/hour is administered, with dose adjustments to maintain aPTT between 1.5 and 2.5 times the control value.

Due to the presence of benzyl alcohol in the formulation, the maximum daily dose of Heparin Sódica ROVI in children under 3 years of age must be less than 9 ml of injectable solution/kg/day.

Elderly patients:

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 5,000 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 followed by continuous infusion is recommended to maintain aPTT levels within the therapeutic range for at least 5 days, 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 every 12 hours with heparin doses adjusted to maintain aPTT values within the therapeutic range is recommended.