Fragmin 2,500 IU/ml solution for injection in vials
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
FRAGMIN 2,500 IU/ml solution for injection in vials
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 you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if the adverse reactions are not listed in this leaflet. See section 4.
Contents of the leaflet:
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What Fragmin is and what it is used for
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What you need to know before using Fragmin
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How to use Fragmin
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Possible side effects
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How to store Fragmin
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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 2,500 IU/ml is used in children and adolescents from 1 month of age for the treatment of blood clots in the veins (venous thromboembolism or VTE).
2. What you need to know before using Fragmin
Do not use Fragmin if:
- you are allergic (hypersensitive) to dalteparin sodium, or to any of the other ingredients of this medicine (listed in section 6), to any type of heparin 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 recently undergone surgery on the central nervous system, eyes, or ears, or if you have trauma to these organs or systems,
- you have a decrease in platelet count (blood cells involved in blood clotting), and when tested for platelet 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 starting to use Fragmin if:
- You are scheduled to receive intramuscular injections of other medications due to the risk of bruising.
- You have a decreased platelet count or platelet defects. Your doctor may order specific tests to determine the cause of this condition.
- 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 (in 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 your potassium levels.
- You are undergoing epidural anesthesia (in one of the membranes surrounding the brain and spinal cord), spinal anesthesia, or a lumbar puncture, and are receiving heparin for prevention; very rarely, hematomas may occur in these areas. 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 cardiac valve prosthesis; 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 Fragmin dose.
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, low molecular weight heparins, or synthetic polysaccharides, as their effects may not be equivalent.
Children and adolescents:
Fragmin is not used in infants under 1 month of age.
Other medicines and Fragmin:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Certain medicines may interact with Fragmin; in such cases, it may be necessary to adjust the dose or temporarily discontinue one of the treatments.
Thrombolytic therapy (clot-dissolving) or certain medicines affecting blood clotting may increase the risk of bleeding when used 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, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Talk to 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 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 decide 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 operate machinery.
Fragmin contains sodium:
This medicine contains 44.1 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 2.21% of the maximum daily sodium intake recommended for an adult.
3. How to use Fragmin
Follow exactly the instructions for using this medicine as given by your doctor. Consult your doctor, pharmacist, or nurse if you have any doubts.
Remember to use your medicine.
Your doctor will tell you the dose, how to use it, and how long your treatment with Fragmin should last.
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. Your doctor will perform the calculation. Your doctor will 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.
The following table shows the recommended initial dose for children and adolescents based on their age:
Children from 1 month to less than 2 years: 150 IU/kg twice daily.
Children from 2 years to less than 8 years: 125 IU/kg twice daily.
Children from 8 years to less than 18 years: 100 IU/kg twice daily.
The effect of Fragmin will be monitored after the initial dose and subsequent dose adjustments through a blood test.
How to inject Fragmin
Your medicine will usually be administered by a doctor or nurse. Fragmin is given under the skin (subcutaneously).
In children, Fragmin is usually injected into a skin fold in the abdomen (a "U"-shaped area around the navel) or in the central part of the thighs.
Sometimes, you will need to receive Fragmin injections outside the hospital setting. If dilution is required 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 (see section “Follow the steps outlined 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. The dose of Fragmin should be injected (or administered) at the time recommended by your doctor.
Follow the steps outlined below
Step 1: How to prepare the syringe for injection:
Gather all the materials you need: vial, syringe, cotton wool with alcohol or soap and water. The vial, syringe, and needle have protective caps. The flip-off cap on the vial may rotate; this is normal. Check that all caps are properly in place and do not use them if they are not correctly sealed. Do not use a bent needle.
Before starting, make sure you know how much to inject. Your doctor should have told you the correct amount of solution to administer. If your doctor has not given you this instruction, contact them.
Prepare the medicine 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 swab. After cleaning, do not touch the stopper with your hands or allow it to come into contact with any surface (see Figures 1 and 2).
Figure 1 Figure 2
Withdraw the correct dose from the vial: Remove the syringe from its plastic or paper cover. Remove the cap covering the needle. Be careful not to touch the needle. With the vial held vertically, push the needle down at a 90-degree angle into the stopper of the vial. Be careful not to bend the needle (see Figure 3).
Figure 3
Turn the vial upside down, keeping the needle attached to the syringe inserted in the vial. The needle and syringe will point upward (see Figure 4).
Figure 4
Ensure the tip of the needle is fully immersed in the medicine. Pull back the plunger of the syringe to the correct dose, checking the dose markings on the side of the syringe barrel (see Figure 5).
Figure 5
Keep the vial upside down with the needle in the vial pointing upward. Gently tap the syringe or "flick" it with your fingertips. This helps move air bubbles to the top of the syringe (see Figure 6).
Figure 6
Once the bubbles have risen to the top of the syringe, gently push the plunger to expel the bubbles out of the syringe and back into the vial. Slowly pull the plunger back again to the correct dose, avoiding bubbles.
After removing the bubbles, check the amount of medicine in the syringe against the dose markings on the side of the syringe barrel to ensure it is correct.
You are now ready to inject. Proceed to Step 2.
Step 2: Choosing and preparing the subcutaneous injection site
If you are injecting yourself or an adult, you may inject Fragmin into an area on the right or left side of the abdomen or toward either side (see shaded areas in Figure 7).
Figure 7
If you are injecting a child, choose one of the recommended injection sites below (see shaded areas in Figure 8):
- A "U"-shaped area around the navel.
- The central part of the thighs.
Figure 8
- Use a different injection site each time you administer a dose.
- Do not administer the injection into 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 position
You or your child should be seated or lying down for the subcutaneous injection. If you are self-injecting, sit in a comfortable position where you can see your abdomen (see Figure 9).
Figure 9
Step 4:
With your thumb and index finger, pinch up a skin fold with one hand. With the other hand, hold the syringe like a pencil. This will be the injection site.
Step 5:
If 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 in (see Figure 10).
Figure 10
If injecting Fragmin into a child, insert the needle fully into the skin with a small, quick movement at an angle between 45° and 90° (see Figure 11).
Figure 11
Step 6:
Push the plunger down completely at a slow and steady pace to deliver 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. Minor bleeding may occur. Do not rub the injection site. You may apply a bandage over the injection site.
Step 7:
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 prescribed, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 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 a missed dose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Fragmin can cause adverse effects, although not everyone will experience 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)
- Increased potassium levels 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 blood
- Osteoporosis (bone porosity)
Adverse effects in children are expected to be the same as 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 25°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 you notice any visible signs of deterioration.
From a microbiological standpoint, the product should be used immediately. If immediate use is not possible, any storage during use and its conditions are the responsibility of the user.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If 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 container and other information
Composition of Fragmin 2,500 IU/ml:
The active substance in Fragmin 2,500 IU/ml is dalteparin sodium.
Each milliliter of solution contains 2,500 IU (anti-Xa) of dalteparin sodium. The total content per 4 ml vial is 10,000 IU (anti-Xa) (=10,000 IU/4 ml).
The other components are: sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Appearance of Fragmin 2,500 IU/ml and contents of the container:
4 ml vials: injectable solution for subcutaneous administration in vials containing 10,000 IU (anti-Xa)/4 ml (2,500 IU/ml).
Marketing Authorization Holder:
Pfizer, S.L.
Avda. de Europa 20-B.
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
Spain
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
Additional information for healthcare professionals:
Fragmin 2,500 IU/ml may be diluted with infusion solutions of sodium chloride (9 mg/ml) or glucose (50 mg/ml) in glass bottles and plastic containers.
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The compatibility of this medicinal product with other products has not been studied except for those mentioned above.
Date of the most recent review of this leaflet: October 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es