FRAGMIN 10,000 IU/ml INJECTABLE SOLUTION IN AMPULES

Introduction

Package Leaflet: Information for the User

FRAGMIN 10,000 IU/ml Solution for Injection in Ampoules

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

Contents of the pack and other information:

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

1. Contents of the pack and other information

1. What Fragmin is and what it is used for

Fragmin belongs to a group of medicines called low molecular weight heparins.

Fragmin 10,000 IU/ml is used in adults aged 18 years and over for:

• Treatment of deep vein thrombosis with or without pulmonary embolism (to treat blood clots already present in the deep veins - a type of blood vessel).
• Prevention of clots in the extracorporeal system during haemodialysis and haemofiltration in patients with chronic renal insufficiency (to prevent clot formation in the dialyser during dialysis or blood filtration in patients with reduced kidney function).
• Treatment of unstable angina and myocardial infarction without Q wave (a type of heart attack).
• Prophylaxis of thromboembolic disease in cancer patients.

2. What you need to know before you use Fragmin

Do not use Fragmin if:

• you are allergic (hypersensitive) to dalteparin sodium, to any of the other ingredients of this medicine (listed in section 6), to any other type of heparin (medicines that prevent blood clotting) other than dalteparin sodium, or to products derived from pigs
• you have acute gastroduodenal ulcer, cerebral haemorrhage, or other significant bleeding
• you have severe coagulation disorders
• you have a condition called acute or subacute bacterial endocarditis (inflammation of one of the heart membranes due to infection)
• you have had surgery on the central nervous system, eyes, or ears, or if you have trauma to these organs or systems
• you have a decrease in the number of platelets (cells present in the blood that are involved in blood clotting) and when a test for aggregation in the presence of dalteparin sodium is performed, the result is positive.

If you are being treated with Fragmin, you will not be able to have an epidural or spinal anaesthetic.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting treatment with Fragmin if:

• You are going to receive intramuscular injections of other medicines due to the risk of haematomas.
• You have a decrease in the number of platelets or defects in them. Your doctor may request specific tests to determine the cause of this problem.
• You have severe renal insufficiency (reduced kidney function) or severe hepatic insufficiency (reduced liver function).
• You have uncontrolled high blood pressure.
• You have retinal disorders due to diabetes or high blood pressure.
• You have recently undergone surgery or have a high risk of bleeding.
• You have had an acute myocardial infarction and are being treated with this medicine.
• You are at risk of elevated potassium levels in the blood due to a disease or taking certain medicines. Your doctor may perform tests to measure potassium levels.
• You are undergoing epidural (in one of the membranes surrounding the brain and spinal cord) or spinal anaesthesia (in the spinal cord) or a lumbar puncture, and you are being administered heparin for prevention purposes; very rare haematomas may occur in these areas. If you experience back pain, numbness, weakness in the lower limbs, or any disorder in the functioning of the intestine or bladder, inform your doctor immediately.
• You have a prosthetic heart valve; the preventive doses of Fragmin may not be sufficient to prevent valve thrombosis.
• You are receiving prolonged treatment for unstable coronary disease, such as prior to revascularization; your doctor may reduce your dose of Fragmin.

Considering your condition and/or age, your doctor may perform tests to control anticoagulant activity and avoid the risk of bleeding or recurrence of thrombosis.

Fragmin must not be exchanged with other unfractionated heparins, low molecular weight heparins, or synthetic polysaccharides, as their effect may not be the same.

Children and adolescents:

Fragmin is not used in newborns under 1 month of age.

Using Fragmin with other medicines:

Tell your doctor, pharmacist, or nurse if you are using, or have recently used, other medicines, including those obtained without a prescription.

Certain medicines may interact with Fragmin 10,000 IU/ml; in these cases, it may be convenient to change the dose or interrupt treatment with one of the medicines.

Thrombolytic treatment (which dissolves the clot) or certain medicines that affect blood clotting may increase the risk of bleeding when combined with Fragmin:

• Aspirin (acetylsalicylic acid).
• Platelet inhibitors (used to decrease platelet aggregation and reduce the risk of blood clots).
• Thrombolytics (used to dissolve blood clots).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat inflammation).
• Vitamin K antagonists and other types of anticoagulants.
• Dextran (used in some artificial tears).

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ask your doctor or pharmacist for advice before taking or using any medicine, including Fragmin.

If you are pregnant, you should only use this medicine when clearly necessary, although Fragmin does not cross the placenta.

It is not recommended to use it with epidural anaesthesia. Inform your doctor if you have an artificial heart valve.

If you are breast-feeding, inform your doctor; he will assess whether treatment with this medicine is appropriate, as Fragmin passes into breast milk in small amounts.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Fragmin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, i.e., it is essentially "sodium-free".

This medicine can be diluted with a solution containing sodium before administration. Inform your doctor if you or your child are on a low-salt (sodium) diet.

3. How to use Fragmin

Follow the instructions for administration of Fragmin 10,000 IU/ml exactly as indicated by your doctor. Ask your doctor, pharmacist, or nurse if you have any doubts.

Remember to take or use your medicine.

Your doctor will tell you the dose, method of use, and duration of your treatment with Fragmin.

Fragmin is administered subcutaneously to treat blood clots.

If you are undergoing haemodialysis or haemofiltration (procedures used to purify the blood), Fragmin will be administered into a vein or into the tube of the dialysis machine.

If you are going to be administered Fragmin to treat blood clots already present in the deep veins, treatment will be started as soon as possible and will continue for at least 5 days or until the levels of prothrombin complex (factors involved in blood clotting) return to normal. You may be given one or two daily doses.

If you are administered a daily dose, it will be 200 IU per kilogram of body weight per day, and it will be applied by subcutaneous injection. The daily dose will not exceed 18,000 IU.

If you are administered two daily doses, they will be 100 IU per kilogram of body weight per day.

If necessary, your doctor will perform analytical tests.

If you are administered Fragmin 10,000 IU/ml for the treatment of unstable angina and myocardial infarction without Q wave, the dose will be 120 IU per kilogram of body weight twice a day, and it will be applied by subcutaneous injection. The maximum dose will be 10,000 IU/12 hours, and the duration of treatment will be 6-8 days. Your doctor may consider that you should take low doses of acetylsalicylic acid at the same time.

If you are administered Fragmin 10,000 IU/ml to prevent clot formation in the dialyser during dialysis or blood filtration due to reduced kidney function, your doctor will tell you how often this medicine will be administered, as well as the dose to be used and the duration of treatment.

Use in children and adolescents

Treatment of blood clots in the veins (symptomatic venous thromboembolism [VTE])

The recommended doses depend on the child's body weight and age group. The doctor will perform the calculation. The doctor will advise on the individualized dose of Fragmin according to these criteria. Do not change the dose or treatment schedule without consulting your doctor first.

This medicine is not suitable for use in the paediatric population due to the risk of dosing errors. The 2,500 IU/ml solution for injection in 4 mL vials is recommended.

The effect of Fragmin will be monitored after the initial dose and subsequent dose adjustment by a blood test.

How to inject Fragmin

Your medicine will be administered by a doctor or nurse. Fragmin is administered by subcutaneous injection. It is usually injected into a skin fold in the abdomen (the "U"-shaped area around the navel) or into the central area of the thighs.

If dilution is necessary before administering Fragmin to children, it must be performed by a healthcare professional. You must follow your doctor's instructions on how and when to inject the diluted medicine provided to you.

If you use more Fragmin than you should

If you have used more Fragmin than you should, consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to use Fragmin

Consult your doctor or pharmacist immediately.

Do not administer a double dose to make up for forgotten doses.

4. Possible side effects

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

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

• Pain and bruising at the injection site
• Reversible decrease in the number of platelets in the blood not mediated by immune mechanisms (type 1)
• Bleeding at any site, which has sometimes been fatal
• Temporary increase in liver enzymes

Uncommon side effects (may affect up to 1 in 100 people):

• Hair loss, skin cell death

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

• Decrease in the number of platelets in the blood mediated by immune mechanisms induced by heparin (type 2)
• Severe allergic reactions
• Localised bleeding inside the skull, abdomen, or other areas, which has sometimes been fatal
• Rash
• Accumulation of blood inside the skull or spinal cord (epidural or spinal haematoma)
• Elevated potassium levels in the blood
• Osteoporosis (porous bones)

Side effects of unknown frequency (cannot be estimated from the available data):

The side effects in children are expected to be the same as those in adults. However, there is limited information on the possible side effects with prolonged use in children.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fragmin

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Fragmin after the expiry date (EXP) stated on the packaging and outer carton. The expiry date is the last day of the month indicated.

Do not use Fragmin if you notice visible signs of deterioration.

The diluted solution is stable for 24 hours at 20°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fragmin 10,000 IU/ml:

The active substance of Fragmin 10,000 IU/ml is dalteparin sodium. Each millilitre of solution contains 10,000 IU (anti-Xa) of dalteparin sodium. The total content per vial is 10,000 IU (anti-Xa).

The other ingredients are: sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance of Fragmin 10,000 IU/ml and contents of the pack:

Ampoules of 1 ml: solution for injection for intravenous or subcutaneous administration in ampoules with 10,000 IU (anti-Xa)/ml.

Marketing Authorisation Holder:

Pfizer, S.L.

Avda. de Europa 20-B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer:

Pfizer Manufacturing Belgium NV/SA

Rijksweg, 12

B-2870 Puurs (Belgium)

Additional information for healthcare professionals:

Fragmin 10,000 IU/ml is compatible with isotonic sodium chloride solutions (9 mg/ml) or glucose (50 mg/ml), both in glass vials and plastic containers.

The compatibility of this medicine with other products has not been investigated.

Date of last revision of this leaflet: June 2025

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