Fragmin 5,000 IU/0.2 ml solution for injection in pre-filled syringes

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

FRAGMIN 5,000 IU/0.2 ml solution for injection in pre-filled syringes

dalteparin sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you get any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Fragmin is and what it is used for

2. What you need to know before using Fragmin

3. How to use Fragmin

4. Possible side effects

5. How to store Fragmin

6. 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 5,000 IU/0.2 ml is used in adults aged 18 years and older for:

• Prophylaxis of thromboembolic disease in surgery (to prevent venous thrombosis when you are undergoing an operation).
• Prophylaxis of thromboembolic disease in non-surgical immobilized patients whose condition can be considered as moderate or high risk (to prevent venous thrombosis when you are not undergoing surgery, but are immobilized and have a significant risk of developing thrombosis).
• Treatment of deep vein thrombosis with or without pulmonary embolism (to treat existing blood clots in the deep veins—a type of blood vessel).
• Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in patients with chronic renal failure (to prevent clot formation in the dialyzer during dialysis or blood filtration in patients with reduced kidney function).
• Prophylaxis of thromboembolic disease in patients with cancer.

2. What you need to know before using 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 type of heparin (medicines that prevent blood clotting) other than dalteparin sodium, or to products derived from pork
• you have acute gastroduodenal ulcer, cerebral hemorrhage, or other significant bleeding
• you have severe coagulation disorders
• you have a disease called acute or subacute infective endocarditis (inflammation of one of the membranes of the heart due to infection)
• you have undergone surgery on the central nervous system, eyes, or ears, or have trauma to these organs or systems
• you have a low platelet count (blood cells involved in blood clotting) and when tested for aggregation in the presence of dalteparin sodium, the result is positive.

If you are being treated with Fragmin, you must not receive epidural or spinal anesthesia.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before using Fragmin if:

• You are due to receive intramuscular injections of other medicines due to the risk of bruising.
• You have a low platelet count or platelet dysfunction. Your doctor may request specific tests to determine the cause of this problem.
• You have severe renal impairment (reduced kidney function) or severe hepatic impairment (reduced liver function).
• You have uncontrolled high blood pressure.
• You have retinal disorders (a part of the eye) due to diabetes or high blood pressure.
• You have recently undergone surgery or are at high risk of bleeding.
• You have suffered an acute myocardial infarction and are being treated with this medicine.
• You are at risk of elevated blood potassium levels due to a medical condition or taking certain medications. Your doctor may perform blood tests to monitor potassium levels.
• You are undergoing epidural anesthesia (in one of the membranes surrounding the brain and spinal cord), spinal anesthesia (in the spinal cord), or lumbar puncture, and are receiving heparin for prophylaxis; hematomas in these areas may very rarely occur. If you experience lower back pain, numbness, weakness in the lower limbs, or any bowel or bladder dysfunction, inform your doctor immediately.
• You have a prosthetic heart valve, as prophylactic 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 Fragmin dose.
• You are allergic or suspect you may have an allergy to latex (natural rubber), or if the needle cap of the Fragmin pre-filled syringes will be handled by someone with a known or suspected latex allergy (natural rubber). The needle cap of Fragmin pre-filled syringes is made of latex (natural rubber), which may cause severe allergic reactions in individuals allergic to latex (natural rubber).

Depending on your condition and/or age, your doctor may perform tests to monitor anticoagulant activity and prevent the risk of bleeding or recurrent thrombosis.

Fragmin must not be interchanged with unfractionated heparins, other low molecular weight heparins, or synthetic polysaccharides, as their effects may not be equivalent.

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 taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Certain medicines may interact with Fragmin 5,000 IU/0.2 ml; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Thrombolytic treatment (which dissolves clots) or certain medicines affecting blood clotting may increase the risk of bleeding when used together with Fragmin:

• Aspirin (acetylsalicylic acid).
• Platelet inhibitors (used to reduce platelet aggregation and lower 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).

Medicines that may reduce the effect of Fragmin include:

• Andexanet alfa (a medicine used to reverse the effects of certain anticoagulants such as apixaban or rivaroxaban).

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking or using any medicine, including Fragmin.

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

Its use in combination with epidural anesthesia is not recommended. Inform your doctor if you have an artificial heart valve.

If you are breastfeeding, inform your doctor; they 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 impair your ability to drive or operate machinery.

Fragmin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe; hence, it is essentially “sodium-free”.

3. How to use Fragmin

Follow exactly the administration instructions for Fragmin 5,000 IU/0.2 ml provided by your doctor. Consult your doctor, pharmacist, or nurse if you have any doubts.

Remember to take or use your medicine.

Your doctor will determine the dose, method of administration, 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 into a vein or into the dialysis machine tubing.

If you are to receive Fragmin to prevent venous thrombosis before undergoing surgery, the dose will depend on the type of surgery you will have.

If you are undergoing general surgery involving a moderate risk of thrombosis, you will receive 2,500 IU (anti-Xa) by subcutaneous injection 2–4 hours before surgery. After surgery, you will receive 2,500 IU once daily during the period of risk or until you are able to move freely.

If you are undergoing oncological or orthopedic surgery involving a high risk of thrombosis, you will receive 2,500 IU (anti-Xa) by subcutaneous injection 2–4 hours before surgery. Twelve hours after surgery, you will receive another 2,500 IU (anti-Xa), followed by 5,000 IU (anti-Xa) daily—one injection of Fragmin 5,000 IU/0.2 ml or two injections of Fragmin 2,500 IU/0.2 ml—throughout the period of risk or until you are able to move freely.

If you are to receive Fragmin 5,000 IU/0.2 ml to prevent venous thrombosis without having undergone surgery but are immobilized, the dose will depend on your level of risk. If your risk of thrombosis is moderate, you will receive 2,500 IU once daily. If it is high, the dose will be 5,000 IU (one injection of Fragmin 5,000 IU/0.2 ml) daily. In both cases, you will receive this medicine throughout the period of risk or until you are able to move freely.

If you are to receive Fragmin 5,000 IU/0.2 ml to treat existing blood clots in deep veins or to prevent clot formation in the dialyzer during dialysis or blood filtration due to reduced kidney function, your doctor will determine how frequently the medicine should be administered, the dose to be used, and the duration of treatment.

Fragmin injections are usually administered by a healthcare professional. They will be given subcutaneously in the front or back area of the abdomen, alternating between the right and left sides.

Use in children and adolescents

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

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

This medicine is not suitable for use in the pediatric population because the pre-filled syringes do not allow dose adjustment based on the child's body weight. It is recommended to use the 2,500 IU/mL injectable solution in 4 mL vials.

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

How to inject Fragmin

Fragmin is administered by subcutaneous injection (under the skin). This section of the leaflet explains how to administer Fragmin. You should follow these instructions only after being trained by your doctor. If you are unsure what to do, speak with your doctor immediately. The dose of Fragmin should be injected (or administered) at the times recommended by your doctor.

If dilution is required before administering Fragmin, it must be performed by a healthcare professional. Follow your doctor's instructions on how and when to inject the diluted medication provided to you.

Please follow the steps outlined below:

Step 1: How to prepare the syringe for injection depends on the specific presentation of Fragmin to be used.

The Needle-Trap safety system is specifically designed to help prevent needlestick injuries after proper use of Fragmin. It consists of a plastic safety device attached to the syringe label. It is used to prevent accidental needlesticks after correct injection of Fragmin. The needle protection device (Needle-Trap) consists of a plastic tab (clamp) aligned parallel to the needle, firmly attached to the syringe barrel label.

The following actions are required to activate the safety system: Lift the syringe, grasp the tip of the plastic needle shield, and bend it away from the protector (see Figure 1).

Figure 1

Remove the grey rubber cap by pulling it outward (see Figure 2).

Figure 2

You will notice an air bubble in the syringe. This is expected and can be ignored. Do not press the plunger yet, as some of the medicine may be lost. The air bubble in disposable syringes should not be expelled before injection, as this may result in loss of medication and therefore a reduced dose.

You are now ready to administer the injection. Proceed to Step 2.

Step 2: Choosing and preparing the subcutaneous injection site

Select one of the recommended injection sites shown below (see shaded areas in Figure 3):

• A "U"-shaped area around the navel.
• The central part of the thighs.

Figure 3

• 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 has psoriasis, do not administer the injection directly into any raised, thick, red, or scaly skin plaques ("psoriatic skin lesions").
• Wash and dry your hands.
• Clean the injection site with a new alcohol-impregnated wipe using circular motions. Allow the skin to dry completely. Do not touch this area again before administering the injection.

Step 3: Adopting the correct posture

You or your child should be sitting or lying down for subcutaneous injection. If you are self-injecting, sit in a comfortable position where you can see your abdomen (see Figure 4).

Figure 4

Step 4:

With your thumb and index finger, pinch a fold of skin with one hand. With the other hand, hold the syringe like a pencil. This will be the injection site.

Step 5:

If you are injecting Fragmin into an adult or yourself, hold the syringe over the skin fold at a right angle (i.e., vertically as shown in the diagram, not at an angle). Insert the needle into the skin until it is fully inserted (see Figure 5).

Figure 5

If you are injecting Fragmin into a child, insert the needle fully into the skin with a quick, small motion at an angle between 45° and 90° (see Figure 6).

Figure 6

Step 6:

Push the plunger completely down slowly and steadily to administer the correct dose. Continue pinching the skin fold while administering the injection, then release the skin fold and withdraw the needle.

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

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

Step 7: If your syringe has a Needle-Trap safety device, activate it

Place the plastic shield against a firm, stable surface and, with one hand, rotate the syringe barrel upward against the needle, forcing the needle into the shield until it locks (see Figure 7).

Continue bending the needle until the syringe exceeds a 45-degree angle with the flat surface to permanently disable it (see Figure 8).

(see Figure 7) (see Figure 8)

Step 8:

Dispose of the syringe and needle in a sharps container. Keep your sharps container out of reach of others. When the sharps container is nearly full, dispose of it according to 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, contact your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service at telephone 91 562 04 20.

If you forget to use Fragmin

Contact your doctor or pharmacist immediately.

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

4. Possible adverse effects

Like all medicines, Fragmin may cause adverse effects, although not everyone experiences them.

Adverse effects observed frequently (may affect up to 1 in 10 patients):

• Pain and bruising at the injection site
• Reversible decrease in blood platelet count not mediated by immune mechanisms (type 1)
• High levels of potassium in the blood (hyperkalaemia), especially in patients with chronic renal failure and diabetes mellitus (see section 2 “Warnings and precautions”)
• Bleeding at any site, which has sometimes been fatal
• Temporary increase in liver enzymes

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

• Hair loss, death of skin cells

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

• Decrease in blood platelet count mediated by immune mechanisms induced by heparin (type 2)
• Severe allergic reactions
• Localized bleeding inside the skull, abdomen, or other sites, sometimes fatal
• Rash
• Accumulation of blood inside the skull or spinal column (epidural or spinal haematoma)
• Increased potassium levels in the blood
• Osteoporosis (porosity of the bones)

Adverse effects in children are expected to be the same as those in adults. However, there is limited information on possible adverse effects with long-term use in children.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.

Do not use Fragmin if particles are present or if discoloration occurs.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fragmin 5,000 IU/0.2 ml:

The active substance of Fragmin 5,000 IU/0.2 ml is sodium dalteparin. Each millilitre of solution contains 25,000 IU (anti-Xa) of sodium dalteparin. The total content per container is 5,000 IU (anti-Xa).

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

Appearance of Fragmin 5,000 IU/0.2 ml and contents of the pack:

Prefilled syringes with needle protection device: injectable solution for subcutaneous administration in prefilled syringes containing 5,000 IU (anti-Xa)/0.2 ml, in packs of 10 and 25 prefilled syringes.

Marketing Authorization Holder:

Pfizer, S.L.

Avda. de Europa 20-B. Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Catalent France Limoges S.A.S.

Z.I. Nord

53, Rue de Dion Bouton

87280 Limoges (France)

or

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Additional information for healthcare professionals/users:

Fragmin 5,000 IU/0.2 ml is compatible with isotonic sodium chloride solutions (9 mg/ml) or glucose solutions (50 mg/ml), both in glass vials and plastic containers.

Compatibility with other products has not been investigated.

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es