PHIVOR 25,000 IU/ml ANTI XA SOLUTION FOR PRE-FILLED SYRINGES

Introduction

Package Leaflet: Information for the User

Phivor 25,000 IU anti-Xa/ml

Injectable solution in pre-filled syringes

Bemiparin sodium

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What is Phivor and what is it used for
2. What you need to know before you use Phivor
3. How to use Phivor
4. Possible side effects
5. Storage of Phivor

1. Contents of the pack and other information

1. What is Phivor and what is it used for

The active substance of Phivor is bemiparin sodium, which belongs to a group of medicines called anticoagulants. These medicines help prevent blood from clotting in the veins.

Phivor is used to treat dangerous blood clots that form, for example, in the veins of the legs and/or lungs (deep vein thrombosis with or without pulmonary embolism).

2. What you need to know before you use Phivor

Do not use Phivor

• If you are allergic to bemiparin sodium, heparin or a similar product (such as enoxaparin, dalteparin, nadroparin) or to any of the other components of this medicine (listed in section 6).
• If you have had an allergic reaction after being treated with a medicine that contains heparin.
• If you are allergic to any substance derived from pigs.
• If you have Heparin-Induced Thrombocytopenia (HIT), a disease that causes a significant decrease in your platelet count (or, as a result of HIT, you suffer from another disease called Disseminated Intravascular Coagulation (DIC), in which your platelets would clump if you use Phivor).

• If you have a disease called endocarditis (inflammation of the heart walls and heart valves).

• If you have any type of disorder that causes you to bleed excessively.
• If you have a severe liver or pancreas disorder.

• If you have any type of damage or injury to your internal organs that could imply a high risk of internal bleeding (e.g., active stomach ulcers, cerebral aneurysms [inflammation of the walls of the brain arteries] or brain tumors).
• If you have had a cerebral hemorrhage.
• If you have had or have an injury or are going to be operated on in the brain, spinal cord, eyes, and/or ears.

• If you are using Phivor, you should not be given epidural or spinal anesthesia (an anesthetic injected into the spinal cord) because it could be dangerous. Therefore, make sure your doctor knows that you are using Phivor before any surgery.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Phivor

• If you are sick with liver disease.
• If you are sick with kidney disease. Your doctor may consider special monitoring. In case of severe disease, your doctor may consider it necessary to adjust the dose.
• If your blood pressure is high and/or difficult to control.
• If you have ever had a stomach ulcer that is no longer active.
• If you have thrombocytopenia, a disease in which there are fewer platelets than normal in the blood, which causes bruising and easy bleeding.
• If you have kidney or bladder stones.
• If you have any type of disease that causes you to bleed easily.
• If you have eye problems due to blood vessel problems.
• If you have diabetes.
• If your test results have shown that you have high potassium levels in your blood.
• Make sure your doctor knows that you are using Phivor if you are going to have a lumbar puncture (a puncture in the lower back for analysis).

Using Phivor with other medicines

Consult your doctor if you think you may be using:

• Any medicine that is injected into the muscle, because these injections should be avoided while you are being treated with Phivor.
• Other anticoagulants such as warfarin and/or acenocoumarol (vitamin K antagonists) to treat and/or prevent blood clots.
• Non-steroidal anti-inflammatory drugs, such as ibuprofen, for example, for arthritis.
• Corticosteroids such as prednisolone, to treat inflammatory diseases, such as arthritis.
• Platelet inhibitors, such as aspirin, ticlopidine, or clopidogrel, to prevent blood clots.
• Medicines that may increase potassium levels in the blood, such as some diuretics and antihypertensives (used to reduce blood pressure).
• Medicines to increase blood volume, such as dextran.
• An injectable medicine for heart problems called nitroglycerin.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use another medicine.

Special tests you may need

• Some patients may need to have their platelet levels in their blood monitored. Your doctor will decide if it is necessary and when (e.g., before starting treatment, on the first day of treatment, then every 3 or 4 days until the end of treatment).

• If you have certain diseases (diabetes, kidney disease) or if you are taking medicines to prevent potassium loss, your doctor may monitor your potassium levels in your blood.

Pregnancy and breastfeeding

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.

Driving and using machines

Phivor does not affect your ability to drive and use machines.

3. How to use Phivor

Follow your doctor's instructions for administering this medicine exactly. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (18-64 years)

The daily dose will depend on your body weight. If you weigh:

• Less than 50 kilograms, the dose will be 0.2 milliliters (= 5,000 IU).
• Between 50 and 70 kilograms, the dose will be 0.3 milliliters (= 7,500 IU).
• Between 71 and 100 kilograms, the dose will be 0.4 milliliters (= 10,000 IU).
• More than 100 kilograms, the dose will be adjusted based on your exact weight to the equivalent of 115 IU per day per kilogram of weight.

IU: the potency of this medicine is described in international units of anti-Xa activity.

Phivor is injected under the skin, usually in a skin fold on one side of the waist (abdomen) or in the upper part of the hip. Normally, your doctor or nurse will give you the injection in the hospital. You may need to continue receiving Phivor when you go home.

• This medicine should never be injected into a muscle or mixed with any other injection.
• It is usually administered once a day.
• Your doctor will tell you how long you should be given this medicine (usually 7-10 days).

• If your doctor has told you that you can inject this medicine yourself, follow your doctor's instructions carefully (see section "How do I inject Phivor?").

Elderly (65 years and over)

They usually receive the same dose as other adult patients. If you have liver problems, please inform your doctor, it is possible that they will decide to monitor you very closely. If you have kidney problems, please inform your doctor, who will monitor you very closely. In case of severe kidney disease, your doctor may consider it necessary to adjust the dose.

Use in children (under 18 years)

Phivor is not recommended for children.

How do I inject Phivor?

Phivor should never be injected into a muscle because it could cause bleeding inside the muscle. Before giving yourself your first injection, you should receive instructions on the correct use of this medicine and the correct injection technique. These instructions should be given by a doctor or other qualified healthcare professional.

Follow these steps:

• Wash your hands well and sit or lie down in a comfortable position.
• Choose a waist area that is at least 5 centimeters from the navel and any scar or bruise, and clean the skin in that area well.
• Use a different site for the injection each day, for example, first on the left side and the next time on the right.
• Remove the cap that covers the needle of the Phivor syringe.
• To keep the needle sterile, make sure it does not touch anything.
• The pre-filled syringe is ready to use.
• Before the injection, do not push the plunger to eliminate air bubbles, as you may lose medicine.

• Hold the syringe with one hand and with the other, using your index and thumb fingers, pinch the skin area you cleaned to form a fold.
• Insert the entire needle into the skin fold, keeping the syringe as upright as possible over the body surface, at a 90-degree angle.
• Push the plunger, making sure to keep the skin fold in the same position until the plunger is all the way down.

• Remove the syringe from the injection site, keeping your finger on the plunger and the syringe upright. Release the skin fold.
• Do not rub the skin where you gave the injection. This will help avoid bruising.

• Do not reuse the needle protection after the injection. Immediately dispose of the syringe by throwing it into the nearest sharps container (with the needle facing in), close the container well with the lid, and keep it out of the reach of children.
• If you think the effect of Phivor is too strong (e.g., because you experience unexpected bleeding) or too weak (e.g., because the dose does not seem to work), tell your doctor or pharmacist.

If you use more Phivor than you should

This can cause bleeding. In this case, consult your doctor or go to the emergency department of the nearest hospital with this leaflet.

In case of overdose or accidental administration, call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Phivor

Do not take a double dose to make up for forgotten doses. Consult your doctor as soon as possible to find out what to do in these cases.

If you stop using Phivor

Always consult your doctor before stopping this medicine.

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

4. Possible side effects

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

Stop using Phivor and consult your doctor or nurse (or go immediately to the emergency department of the nearest hospital) if you experience any of the following side effects:

Common (may affect up to 1 in 10 people):

• Unusual or unexpected bleeding, for example, blood in the urine or stool, which can cause hemorrhagic anemia.

Rare (may affect up to 1 in 1,000 people):

• Severe decrease in platelet count (type II thrombocytopenia), which can lead to bruising, bleeding gums, nose, and mouth, and rashes.
• Skin damage (necrosis) at the injection sites.
• Intra-spinal hematomas after spinal or lumbar anesthesia (back pain, numbness, and loss of strength or sensation in the legs, incontinence in the intestine or bladder). These hematomas can cause various degrees of disability, including prolonged or permanent paralysis.
• Severe allergic reactions (fever, shivering, difficulty breathing, swelling of the vocal cords, dizziness, sweating, hives, rash, itching, low blood pressure, flushing, fainting, bronchial constriction, laryngeal edema).

Other side effects:

Very common (affects more than 1 in 10 people):

• Bruises, skin spots, itching, and some pain in the areas where you injected the medicine.

Common (may affect up to 1 in 100 people):

• A slight and transient increase in certain liver enzymes (transaminases) in the blood, which may appear in blood tests.

Uncommon (may affect up to 1 in 1,000 people):

• Mild allergic reactions on the skin (rash, skin rash, hives, itching, urticaria).
• Slight and transient decrease in platelet count (type I thrombocytopenia), which may appear in blood tests.

Frequency not known (cannot be estimated from the available data):

• Hyperkalemia (increased potassium levels in the blood).
• Bone fragility (osteoporosis) associated with prolonged treatment with heparin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Phivor

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

Do not store above 25°C. Do not freeze.

Do not use this medicine if you notice:

• The protective packaging is open.
• The protective packaging is damaged.
• The medicine contained in the syringe is cloudy.
• Small particles in the medicine.

Once the blister pack containing the syringe is opened, the medicine must be used immediately.

Expiration date:

Do not use this medicine after the expiration date stated on the packaging.

The expiration date is the last day of the month indicated.

Disposal

This medicine is presented in single-use syringes.

Dispose of used syringes in a sharps container.

Do not store them after use.

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

6. Contents of the pack and other information

Composition of Phivor

The active substance is: Bemiparin sodium 25,000 IU

The other components are: Water for injections.

Appearance of the product and packaging contents

The medicine contained in the syringes is a clear, colorless or slightly yellowish solution, without visible particles.

Phivor 25,000 IU is available in packs of 2, 10, 30, and 100 pre-filled syringes. Each syringe contains 0.2 ml, 0.3 ml, or 0.4 ml of solution.

Each 0.2 ml syringe provides a dose of bemiparin sodium of 5,000 IU.

Each 0.3 ml syringe provides a dose of bemiparin sodium of 7,500 IU.

Each 0.4 ml syringe provides a dose of bemiparin sodium of 10,000 IU.

Marketing authorization holder and manufacturer

Marketing authorization holder

GINELADIUS, S.L.

C/ Rufino González 50, 28037 Madrid - Spain

Manufacturer

ROVI Pharma Industrial Services, S.A.

C/ Julián Camarillo, 35

28037 MADRID

LABORATORIOS FARMACÉUTICOS ROVI, S.A.

C/ Julián Camarillo, 35

28037 MADRID

This medicine is authorized in the Member States of the European Economic Area under the following names:

Ivor:Italy, Portugal

Zibor:Czech Republic, Estonia, Ireland, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, United Kingdom

Phivor:Spain

Date of last revision of this leaflet: 05/2023

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