Prospect: Information for the User

FRAGMIN 10,000 UI/ml injectable solution in ampoules

Dalteparin sodium

Read this prospect carefully before starting to use the medicine because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nursing staff.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nursing staff, even if they do not appear in this prospect. See section 4.

6. Contents of the container and additional information

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

Fragmin 10,000 UI/ml is used in adults aged 18 years or older for:

• Treatment of deep vein thrombosis with or without pulmonary embolism (to treat existing blood clots in deep veins - a type of blood vessels).
• Prevention of extracorporeal coagulation during hemodialysis and hemofiltration in patients with chronic renal insufficiency (to prevent clot formation in the dialyzer during dialysis or blood filtration performed in patients with a decreased kidney function).
• Treatment of unstable angina and myocardial infarction without Q wave (a type of heart attack).
• Prophylaxis of thromboembolic disease in patients with cancer.

Do not use Fragmin if:

• You are allergic (hypersensitive) to dalteparin sodium, any of the other components of this medication (including in section 6), any type of heparin (blood clotting medications) other than dalteparin sodium or products derived from pork
• You have an acute peptic ulcer, cerebral hemorrhage, or other significant bleeding
• You have severe coagulation disorders
• You have an acute or subacute bacterial endocarditis (inflammation of one of the heart membranes due to an infection)
• You have undergone surgery in 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 intervene in blood clotting) and when a platelet aggregation test is performed in the presence of dalteparin sodium, the result is positive.

If you are being treated with Fragmin, you will not be able to receive epidural or spinal anesthesia.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Fragmin if:

• You are to receive intramuscular injections of other medications due to the risk of hematomas.
• 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 (decrease in kidney function) or severe liver insufficiency (decrease in liver function).
• You have uncontrolled high blood pressure.
• You have retinal disorders (a part of the eye) due to diabetes or uncontrolled 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 medication.
• You are at risk of developing hyperkalemia (elevated potassium levels in the blood) due to a disease or taking certain medications. Your doctor may perform tests to measure potassium levels.
• You are undergoing epidural or spinal anesthesia, or lumbar puncture, and are being administered heparin for prevention, very rarely hematomas may appear in these areas. If you experience back pain, numbness, weakness in the lower extremities, or any disorder in the functioning of the intestines or bladder, immediately inform your doctor.
• You have a heart valve prosthesis, the preventive doses of Fragmin may not be sufficient to prevent valve thrombosis.
• You are receiving prolonged treatment for unstable coronary disease, such as before revascularization, your doctor may reduce your Fragmin dose.

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

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

Children and adolescents:

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

Use of Fragmin with other medications:

Inform your doctor, pharmacist, or nurse if you are using, or have recently used, other medications, including those purchased without a prescription.

Certain medications may interact with Fragmin 10,000 UI/ml; in these cases, it may be advisable to change the dose or discontinue treatment with one of the medications.

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

• Those that affect the blood and blood clotting, such as aspirin, vitamin K antagonists (which prevent the action of vitamin K, whose function is to facilitate blood clotting, such as Sintrom -acenocoumarol-), and dextran. However, if you suffer from unstable angina or myocardial infarction without Q wave (a type of myocardial infarction), you should receive low-dose oral aspirin, unless contraindicated.
• A type of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin, for the treatment of inflammation and pain, especially in patients with renal insufficiency (decrease in kidney function).

Pregnancy, breastfeeding, and fertility:

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

Consult your doctor or pharmacist before taking or using a medication, including Fragmin.

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

It is not recommended to use this medication with epidural anesthesia. Inform your doctor if you have an artificial heart valve.

If you are breastfeeding, inform your doctor; he will evaluate whether treatment with this medication is appropriate, as Fragmin passes in small amounts into breast milk.

Driving and operating machinery:

This medication does not alter the ability to drive vehicles or use machinery.

Fragmin contains sodium:

This medication contains less than 1 mmol of sodium (23 mg) per ampoule: it is essentially "sodium-free."

This medication can be diluted with a solution containing sodium before administration. Inform your doctor if you or your child follow a low-sodium diet.

Follow exactly the administration instructions for Fragmin 10,000 UI/ml as indicated by your doctor. Consult your doctor, pharmacist, or nursing staff if you have any doubts.

Remember to take or use your medication.

Your doctor will indicate the dose, mode of use, and duration of your treatment with Fragmin.

Fragmin is administered under the skin (subcutaneously) to treat blood clots.

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

If you are being administered Fragmin totreat existing blood clots in deep veins, treatment will begin as soon as possible, and will continue for at least 5 days or until the prothrombin complex levels (factors involved in blood coagulation) return to their normal level. You may be administered one or two daily doses.

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

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

If necessary, your doctor will perform analytical controls.

If you are being administered Fragmin 10,000 UI/ml for thetreatment of unstable angina and myocardial infarction without Q wave, the dose will be 120 UI per kilogram of body weight twice a day, and will be applied via subcutaneous injection. The maximum dose will be 10,000 UI/12 hours, and the treatment duration 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 being administered Fragmin 10,000 UI/ml toprevent clot formation in the dialyzer during dialysis or blood filtrationperformed because kidney function is decreased, your doctor will indicate how often this medication will be administered, as well as the dose to be used and the treatment duration.

Use in children and adolescents

Treatment of blood clots in veins (symptomatic deep vein thrombosis [DVT])

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

This medication is not suitable for use in the pediatric population due to the risk of dosing errors. It is recommended to use the 2,500 UI/ml injectable solution presentation in 4 mL vials.

Fragmin's effect will be monitored after the initial dose and subsequent dose adjustment through a blood test.

How to inject Fragmin

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

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

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, phone 91 562 04 20.

If you forget to use Fragmin

Consult your doctor or pharmacist immediately.

Do not administer a double dose to compensate for missed doses.

Like all medications, Fragmin may produce adverse effects, although not all people will experience them.

Adverse effects observed frequently (may affect up to one in 10 patients):

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

Rare adverse effects (may affect up to one in 1,000 patients):

• Hair loss, death of skin cells

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

• Decrease in the number of blood platelets mediated by immune mechanisms induced by heparin (type 2)
• Severe allergic reactions
• Localized bleeding in the interior of the skull, abdomen, or other areas, sometimes fatal
• Rash
• Accumulation of blood in the interior of the skull or spinal column (epidural or spinal hematoma)
• Elevation of potassium levels in the blood
• Osteoporosis (porosity in the bones)

It is expected that adverse effects in children will be the same as those in adults. However, there is limited information available on possible adverse effects with prolonged use in children.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not use Fragmin after the expiration date (CAD) shown on the packaging and outer carton. The expiration date is the last day of the month indicated.

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

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

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

Medicines should not be disposed of in the drains or trash. Dispose of the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

Composition of Fragmin 10,000 UI/ml:

The active ingredient of Fragmin 10,000 UI/ml is dalteparin sodium. Each milliliter of solution contains 10,000 UI (anti-Xa) of dalteparin sodium. The total content per package is 10,000 UI (anti-Xa).

The other components are: sodium chloride, sodium hydroxide, hydrochloric acid and water for injectable preparations.

Appearance of Fragmin 10,000 UI/ml and contents of the package:

1 ml ampoules: injectable solution for intravenous or subcutaneous administration in ampoules with 10,000 UI (anti-Xa)/ml.

Holder of the Marketing Authorization:

Pfizer, S.L.

Avda. de Europa 20-B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for Manufacturing:

Pfizer Manufacturing Belgium NV/SA

Rijksweg, 12

B-2870 Puurs (Belgium)

Additional information for healthcare professionals:

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

Compatibility with other products has not been investigated.

Last review date of this leaflet: September 2023

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