Label: Information for the User

FRAGMIN2,500 UI/mlInjectable solution in vials

Dalteparin sodium

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

• Keep this label as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nursing staff.
• This medication 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 are not listed in this label. See section 4.

1. What you need to know before starting to use Fragmin
2. How to use Fragmin
3. Possible adverse effects
4. Storage of Fragmin

6. Contents of the package and additional information

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

Fragmin 2.500UI/ml is used in children and adolescents aged 1month and above for the treatment of blood clots in the veins (deep vein thrombosis or DVT).

Do not use Fragmin if:

• You are allergic (hypersensitive) to dalteparin sodium, or to any of the other components of this medication (listed in section 6), to any other type of heparin (blood-thinning medications) other than dalteparin sodium, or to products derived from pigs,
• 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 participate 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 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 hepatic insufficiency (decrease in liver function).
• You have uncontrolled high blood pressure.
• You have retinal disorders (part of the eye) 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 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, rare cases of hematomas in these areas may occur. 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 for infants under 1 month of age.

Other medications and Fragmin:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Certain medications may interact with Fragmin; in these cases, it may be necessary 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 aspirin orally, 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 44.1 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.21% of the maximum daily sodium intake recommended for an adult.

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Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor, pharmacist, or nursing staff if you have any doubts.

Remember to use your medication.

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

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.

The following table shows the recommended initial dose for children and adolescents based on their age:

Infants from 1 month to less than 2 years:150UI/kg twice a day.

Children from 2 years to less than 8 years:125UI/kg twice a day.

Children from 8 years to less than 18 years:100UI/kg twice a day.

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

How to inject Fragmin

Your medication will be administered generally by a doctor or nurse. Fragmin is administered under the skin (subcutaneously).

In children, Fragmin is injected generally in a skin fold in the abdomen (the area in the shape of a "U" around the navel) or in the central part of the thighs.

In some cases, you will need to receive Fragmin injections outside the hospital setting. If you need to dilute Fragmin before administering it to children, a healthcare professional should do it. You should follow your doctor's instructions on how and when to inject the diluted medication provided (see the section "Follow the steps explained below").

This section of the leaflet explains how to inject Fragmin yourself or your child. You should only follow these instructions after being trained by your doctor. If you are unsure what to do, speak with your doctor immediately. You should inject (or administer) the Fragmin dose at the recommended time by your doctor.

Follow the steps explained below

Step 1: preparing the syringe for injection:

Gather all the materials you need: vial, syringe, cotton with alcohol or water, and soap. The vial, syringe, and needle have protective caps. The vial cap can be turned; this is normal. Make sure all the caps are properly in place, and if they are not, do not use them. If a needle is bent, do not use it.

Before starting, make sure you know how much you are going to inject. Your doctor should have indicated the correct amount of solution to administer. If your doctor has not given you this instruction, contact them.

Prepare the medication dose:remove the plastic cap from the top of the vial (if present). Do not remove the rubber stopper or the aluminum ring around the top of the vial. Clean the rubber stopper of the vial with an alcohol wipe. After cleaning, do not touch the stopper with your hands or let it touch any surface (see Figures 1 and 2).

Figure 1Figure 2

Extract the correct dose from the vial:remove the syringe from the plastic or paper cover. Remove the cap that covers the needle. Be careful not to touch the needle. With the vial in a vertical position, push the needle down at an angle of 90 degrees into the vial stopper. Be careful not to bend the needle (see Figure 3).

Figure 3

Turn the vial upside down, keeping the needle attached to the syringe in the vial. The needle and syringe will point upwards (see Figure 4).

Figure 4

Make sure the needle tip is completely covered by the medication. Pull the syringe plunger back to the correct dose of medication, checking the dose level marks on the syringe barrel side (see Figure 5).

Figure 5

Keep the vial upside down, with the needle in the vial pointing upwards. Gently tap the syringe or "move" it with the tip of your fingers. This helps to displace the bubbles to the top of the syringe (see Figure 6).

Figure 6

Once the bubbles are at the top of the syringe, gently push the plunger to force the bubbles out of the syringe and back into the vial. Slowly pull the syringe plunger back again to the correct dose, avoiding bubbles.

After eliminating the bubbles, check the amount of medication in the syringe according to the dose level marks on the syringe barrel side to ensure it is correct.

You are now ready to inject. Continue with Step 2.

Step2: choosing and preparing the subcutaneous injection site

If you are injecting yourself or an adult, you can inject Fragmin in a site on the right or left side of your stomach or in either of the two sides (see the shaded areas in Figure 7).

Figure 7

If you are injecting a child, choose one of the recommended injection sites below (see the shaded areas in Figure8):

A site in the shape of an "U" around the navel.

Central part of the thighs.

Figure8

•Use a different injection site each time you administer a dose.

•Do not administer the injection in areas where the skin is painful, bruised, red, or hard. Avoid areas with scars.

•If you or the child have psoriasis, do not administer the injection directly in any raised, thick, red, or scaly skin patches ("psoriasis skin lesions").

•Wash and dry your hands.

•Clean the injection site with a new alcohol wipe, moving in circular motions. Let the skin dry completely. Do not touch this area again before administering the injection.

Step3: adopting the correct position

You or your child should be seated or lying down for the subcutaneous injection. If you are self-injecting the medication, sit in a comfortable position where you can see your stomach (see Figure9).

Figure9

Step4:

With your thumb and index finger, lift a skin fold with one hand. With the other hand, hold the syringe as if it were a pencil. This will be the injection site.

Step5:

If you are injecting Fragmin into an adult or yourself,hold the syringe over the skin fold, keeping it at a right angle (i.e., vertically as in the diagram, not at an angle). Insert the needle into the skin until it is fully in (see Figure10).

Figure10

If you are injecting Fragmin into a child,insert the needle into the skin until it reaches the bottom with a small and quick movement, at an angle of between 45° and 90° (see Figure11).

Figure11

Step6:

Step 6:

Push the plunger all the way down at a slow and constant speed to administer the correct dose. Continue to pinch the skin fold while administering the injection and then release the skin fold and remove the needle.

If there is any bleeding at the injection site, apply gentle pressure. Do not rub the injection site, as this can cause hematomas.

Press the injection site with a cotton ball for 10seconds. Some bleeding may occur. Do not rub the injection site. You can place a bandage over the injection site.

Step7:

Dispose of the syringe and needle in a sharp object container. Keep your sharp object container out of reach of others. When the sharp object container is almost full, dispose of it according to the instructions or speak with your doctor or nurse.

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 forgot to use Fragmin

Consult your doctor or pharmacist immediately.

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

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

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 that has sometimes been fatal
• Temporary increase in liver enzymes

Adverse effects that are rare (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 that does not appear 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 25°C

Do not use Fragmin after the expiration date (CAD) that appears 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.

From a microbiological point of view, 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 medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition of Fragmin 2.500 UI/ml:

The active principle of Fragmin 2.500 UI/ml is dalteparin sodium.

Each milliliter of solution contains 2,500 UI (anti-Xa) of dalteparin sodium. The total content per 4 ml vial is 10,000 UI (anti-Xa) (=10,000 IU/4 ml).

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

Appearance ofFragmin 2.500 UI /mland contents of the packaging:

4 ml vials: injectable solution for subcutaneous administration in vials with 10,000 UI (anti-Xa)/4 ml (2,500 UI /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

Rijksweg 12

2870Puurs-Sint-Amands

Belgium

Additional information for healthcare professionals:

Fragmin 2.500 UI /ml can be diluted with sodium chloride solutions (9 mg/ml) or glucose solutions (50 mg/ml) in glass bottles and plastic containers.

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The compatibility of this medication with other products has not been investigated except for those mentioned above.

Last review date of this leaflet: August 2024

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