HEPARIN SODIUM ROVI 1000 IU/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

Sodium Heparin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sodium Heparin ROVI 1,000 UI/ml Injectable Solution and what is it used for
2. What you need to know before starting to use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution
3. How to use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution
4. Possible side effects
5. Storage of Sodium Heparin ROVI 1,000 UI/ml Injectable Solution
6. Package Contents and Additional Information

1. What is Sodium Heparin ROVI 1,000 UI/ml Injectable Solution and what is it used for

Sodium Heparin belongs to the group of medications called antithrombotics, i.e., those used to prevent and treat the formation of blood clots (thrombi).

This medication is presented in the form of an injectable solution, with a concentration of sodium heparin of 1,000 UI/ml, in 5 ml vials.

This medication is indicated for:

• Treatment and prevention of venous thromboembolic disease: deep vein thrombosis, pulmonary thromboembolism.
• 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.

Sodium Heparin ROVI is indicated in pediatric population from 28 days of birth and in adults (see section 2).

2. What you need to know before starting to use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

Do not use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

• If you are allergic to sodium heparin, substances of porcine origin, or any of the other components of this medication (listed in section 6).
• If you have a history of or suspected decrease in platelet count (thrombocytopenia).
• 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 liver or pancreatic disorder.
• If you are going to undergo surgery or have suffered damage to the central nervous system, eyes, or ears.
• If you have an infection in the heart called acute bacterial endocarditis.
• If you have a disease called Disseminated Intravascular Coagulation (DIC) due to a decrease in platelet count caused by heparin.
• If you have received heparin for treatment purposes, it is contraindicated to use regional anesthesia in scheduled surgical interventions.
• In preterm and newborn infants, due to the content of benzyl alcohol in this medication.
• If you are bleeding or have a high risk of bleeding due to problems with blood coagulation.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

• If you have a disease or injury that may bleed, such as uncontrolled hypertension, history of gastroduodenal ulcer, in case of vascular eye 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 potassium levels in the blood, as may 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 monitoring your potassium levels.
• If you have or have had low platelet count (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 skin degeneration occurs at the injection site when administered subcutaneously.
• If it is administered to the elderly, special caution should be taken due to the risk of increased bleeding.
• If it is administered to low-birth-weight neonates, special caution should be taken due to the risk of cerebral bleeding.
• If it is administered to women during breastfeeding, special caution should be taken due to the risk of bone alterations.
• If you are going to receive other agents via the intramuscular route, due to the risk of hematomas during heparin administration.

Other Medications and Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

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

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

• 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 some cephalosporins (cefamandole, cefoperazone), some contrast media, asparaginase, and epoprostenol, as these medications increase the effect of heparin and consequently increase the risk of bleeding.

• Alprostadil, as it may potentiate the anticoagulant effect of heparin and increase the risk of hemorrhage, as well as alter the results of analytical tests.

• Oral antidiabetics (sulfonylureas), medications containing benzodiazepines (chlordiazepoxide, diazepam, oxazepam), or propranolol, as their effect may be increased in the presence of heparin.

• Epoetin or intravenous nitroglycerin, as they may decrease the anticoagulant effect of heparin and may require dose adjustment.

• Medications that increase potassium levels in the blood.

Pregnancy and Breastfeeding

Pregnancy:

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

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

Breastfeeding:

Before starting treatment with Sodium Heparin ROVI 1,000 UI/ml Injectable Solution, inform your doctor if you are breastfeeding. Sodium Heparin ROVI 1,000 UI/ml Injectable Solution is not excreted in breast milk.

Use in the Elderly

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

Driving and Using Machines

Sodium Heparin ROVI 1,000 UI/ml Injectable Solution does not affect the ability to drive vehicles or use hazardous or precision machinery.

Sodium Heparin ROVI 1,000 UI/ml Injectable Solution contains Benzyl Alcohol

This medication should not be administered to premature or newborn infants because it contains 10 mg/ml of benzyl alcohol. It can cause toxic reactions and allergic reactions in children under 3 years of age.

3. How to use Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

The vials containing Sodium Heparin ROVI 1,000 UI/ml Injectable Solution are ready for immediate use by intravenous (continuous infusion with perfusion pump or bolus), intra-arterial, or subcutaneous route. It should not be administered by intramuscular route, and the intramuscular injection of other agents should be avoided due to the risk of hematoma formation during heparin treatment.

Your doctor will perform regular checks 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 ROVI 1,000 UI/ml Injectable Solution. Do not stop treatment prematurely.

The dose of sodium heparin should be individualized according to the patient's weight and clinical situation. It should also be adjusted according to coagulation time or activated partial thromboplastin time (aPTT).

In the section intended only for healthcare professionals at the end of this leaflet, the doses to be used for different populations are detailed.

Adults:

Your doctor will adjust the dose according to coagulation times.

Pediatric population:

Children from 28 days of birth

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 insufficiency:

A lower dose may be necessary. 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 specialty:

Deep subcutaneous route:

Take a skin fold, without pressing, between the thumb and index finger of one hand. Maintaining this fold, insert the needle perpendicularly to the skin fold with the other hand, i.e., at a right angle to the skin. Carefully introduce the needle and slowly inject the necessary dose into the subcutaneous tissue. Remove the needle after injection, pressing the application site for a few minutes. It is recommended to rotate the area to avoid edema formation.

If you use more Sodium Heparin ROVI 1,000 UI/ml Injectable Solution 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 Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

Do not administer a double dose to make up for the forgotten dose, and consult your doctor as soon as possible to indicate what to do in these cases.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects have been observed:

Frequent side effects (affect 1 to 10 out of 100 patients):

• Hemorrhagic complications, especially when high doses are administered. If you notice nasal bleeding, bleeding in the urine, stools, or any other type of bleeding, consult your doctor or go to the emergency department of the nearest hospital, with this leaflet. Bleeding can be reversed with 1% protamine sulfate.
• Alterations in liver function test results (increased serum levels of hepatic transaminases).

Uncommon side effects (affect 1 to 10 out of 1,000 patients):

• Allergic skin manifestations (redness, itching).
• Hair loss (alopecia) in long-term treatments.
• Osteoporosis.
• Decreased platelet count in the blood (thrombocytopenia).
• Increased serum potassium levels in case of kidney disease or diabetes.
• Suppression of aldosterone synthesis (hyperkalemia).

Rare side effects (affect 1 to 10 out of 10,000 patients):

• Skin degeneration at the injection site, if administered subcutaneously.
• Severe general allergic reactions (nausea, vomiting, fever, difficulty breathing, bronchospasm, throat swelling, decreased blood pressure).
• Prolonged erection of the penis (priapism).
• Severe decrease in platelet count in the blood of immune-allergic nature (type II thrombocytopenia).

Very rare side effects (affect less than 1 out of 10,000 patients):

• In very rare cases, if you have been treated with anticoagulant medications and undergo epidural or spinal anesthesia, bleeding may occur in the spinal canal. This can damage the nerves, causing loss of strength or sensation in the legs or lower half of the body.

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

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

Reporting 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 Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sodium Heparin ROVI 1,000 UI/ml Injectable Solution

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

Do not store above 30°C.

Once the vial is opened, administer the product immediately.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Heparin Sodium ROVI 1,000 UI/ml Injectable Solution

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

Appearance of the Product and Container Content

Colorless, transparent solution, free from visible particles.

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

Only some package 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 Last Revision of this Prospectus:October 2023

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/

This information is intended only for healthcare professionals:

The recommended dose varies depending on the different indications, being in each case the following:

Adults:

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

An initial intravenous bolus of 80 UI/kg of heparin sodium will be administered, which may be increased to 120 UI/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 UI/kg. Subsequently, the dose must 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. Control should be performed 4-6 hours after starting the infusion and at similar intervals whenever a change in the administered dose 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 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 UI of heparin sodium is recommended, followed by 32,000 UI/24h in continuous intravenous infusion adjusted according to APTT.

Acute myocardial infarction after thrombolytic therapy:

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

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 UI/kg, varying the dose based on coagulation tests to control anticoagulation levels.

Hemodialysis:Before starting dialysis, a bolus injection of 25-30 UI/kg is administered, followed by a continuous infusion of 1,500-2,000 UI per hour throughout the hemodialysis session. The heparin infusion is stopped approximately 30 minutes before the end of the dialysis process to allow for recovery of hemostasis before removing the catheter.

Pediatric population:

Children from 28 days of age:It is recommended to adjust the dose according to weight and required APTT levels. In general, for anticoagulation, 80 UI/kg will be administered in bolus, followed by 18 UI/kg/h, adjusting the dose to maintain an APTT between 1.5 and 2.5 times the control value.

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

Elderly patients:

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, and doses of up to 10,000 UI every 12 hours may be necessary during the third trimester of pregnancy.

Careful monitoring according to APTT is advised.

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 then 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.