Patient leaflet - Fragmin 10 000 IU/1 ml solution for injection

1. What Fragmin is and what it is used for

Fragmin contains the active ingredient dalteparin sodium. It is available in 1 strength of 10,000 IU/ 4 ml solution for injection.

Abbreviation: IU = International units

Fragmin belongs to a group of medicines called low molecular weight heparins or antithrombotics, which help prevent the formation of blood clots by thinning the blood.

Fragmin is indicated in adults above 18 years old for:

Haemodialysis/Haemofiltration: Fragmin may be used in patients having
haemodialysis or haemofiltration. Fragmin prevents blood clots being formed in the tubes of the equipment.
Haemodialysis and haemofiltration are methods
of removing excessive natural waste products
from the blood of people whose kidneys are no longer able to perform this function.
- Venous thromboembolism:
  Venous thromboembolism is a condition where
  blood clots develop in the legs (deep vein thrombosis) or the lungs (pulmonary embolism). This can happen following surgery, pregnancy or long periods of bed rest.
- Unstable coronary artery disease: In patients with coronary artery disease, the
  coronary arteries (blood vessels to the heart) are furred up and narrowed by patches of fatty deposits.
  Unstable coronary artery disease means that
  a furred up bit of the artery has ruptured and a clot has formed on it, reducing the flow of blood to the heart.

Fragmin helps to prevent more clots being formed.

Fragmin is indicated in children for:

Treatment of blood clots in the veins (venous thromboembolism or VTE) in children and adolescents 1 month of age and older.

Ask your doctor if you are unsure why you have been given Fragmin.

2. What you need to know before you are given Fragmin

You should not be given Fragmin:

if you are allergic (hypersensitive) to the active
ingredient dalteparin sodium or a similar product or any of the other ingredients of this medicine (listed in section 6).
if you have a stomach ulcer or ulcer of the
duodenum (small intestine).
if you have suffered from a brain haemorrhage
(bleeding in your brain).
if you suffer from any condition which may cause
you to bleed more easily (e.g. haemophilia, liver failure). Ask your doctor if you are unsure.
if you have a condition called septic endocarditis
(an infection and inflammation of the lining of the heart and heart valves). Your doctor will have told you if you have this.
if you have an injury to, or are about to have an
operation involving your spine, head, eyes or ears.
If you are suffering from thrombocytopenia (a
condition where there are fewer clotting cells known as platelets in the blood, causing you to bruise and bleed more easily). Your doctor will have told you if you have this.

If you are receiving Fragmin to treat blood clots, you should not have a local, spinal or epidural anaesthetic.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you take Fragmin:

if you have conditions which make you more
susceptible to bleeding e.g.:
- after an operation or trauma
- a stroke caused by a bleed
- severe liver or kidney failure
- abnormal or low numbers of platelets
  (clotting cells)
- eye disease caused by blood pressure or
  diabetes
- taking other medicines that thin the blood
  (e.g. aspirin, warfarin, dipyridamole)
- uncontrolled high blood pressure.
if you have been told by your doctor that you
have a lot of potassium in your blood or have a low blood pH. Your doctor will monitor your blood regularly before and during treatment.
- if you have ever had an operation to insert
  artificial heart valves.
- if you need any other injections.

You may need to have blood tests to monitor the effects of Fragmin:

if you have kidney failure or liver problems
if you are very thin or morbidly obese
if you are pregnant
if you are at increased risk of bleeding or
rethrombosis (more blood clots)
if you are a child.

Your doctor will monitor your blood regularly before and during treatment.

Children and adolescents

Fragmin is not used for new born babies under 1 month of age.

Other medicines and Fragmin

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or are planning to take or use any other medicines. This includes medicines that you have bought for yourself.

Some medicines can affect the way Fragmin works, or Fragmin itself can reduce the effectiveness of other medicines taken at the same time.

Medicines that increase the effect of Fragmin include: Thrombolytic (clot-dissolving) treatment or certain medicines which affect blood clotting may increase the risk of haemorrhage 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)
Nonsteroidal anti-inflammatories (NSAIDs) (medicines
used to treat inflammation)
Antagonists of GP IIb/IIIa receptors (medicines
affecting platelet aggregation, used to treat cardiac disorders)
Antagonists of vitamin K and other types of (oral
anticoagulants)
Dextran (used in certain artificial tears).

Medicines that can reduce the effect of Fragmin, include:

Those for allergy and hay fever (e.g.
antihistamines)
Those used for heart or circulation problems
(e.g. digoxin or digitoxin)
Antibiotics known as tetracyclines which are
used to treat bacterial infections
Vitamin C (e.g. some vitamin supplements)
Andexanet alfa (medicine used to reverse the
effects of certain blood thinning medications, such as apixaban or rivaroxaban).

Other medicines that may interfere with Fragmin include:

Those used to treat angina (e.g. intravenous
nitroglycerine)
Antibiotics such as high dose penicillin which are
used to treat bacterial infections
Anti-malarials (e.g. quinine)
Tobacco smoking.

Please note that if you are being treated with Fragmin for unstable coronary artery disease your doctor may adjust your dose of aspirin accordingly.

Please tell your doctor or pharmacist if you are taking or have recently taken any other low molecular weight heparins or anti-thrombotics.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Fragmin has not been found to cause harmful effects during pregnancy. The possibility of harm to the baby

appears remote. Tell your doctor if you are pregnant and they will advise you.

However, if you have an artificial heart valve and are pregnant, the usual dose of Fragmin might not be enough to prevent a blood clot. Your doctor will discuss this with you.

If you are receiving Fragmin to treat blood clots, you should not have a local, spinal or epidural anaesthetic.

Ask your doctor or pharmacist for advice before taking this medicine whilst breast-feeding.

Driving and using machines

Fragmin does not affect the ability to drive and operate machinery.

Fragmin contains sodium

Fragmin 10,000 IU /4 ml vial contains

24.2 mg sodium (main component of cooking/ table salt) in each vial. This is equivalent to 1.21% of the recommended maximum daily dietary intake of sodium for an adult.

This product may be prepared with a solution that contains sodium. Tell your doctor if you or your child are on a low salt (sodium) diet.

3. How Fragmin is given to you

Your medicine will be administered by a doctor or nurse. Fragmin is given either as an injection into a vein or as subcutaneous injection, which means it is injected beneath the skin. It is usually injected into a skin fold in your abdomen (stomach), or the outer aspects of your thigh. If you are undergoing hemodialysis (a process used to purify the blood) or hemofiltration (where the water in the blood is replaced with an electrolyte solution), the medicinal product can be either administered intravenously or into the tube of the dialysis machine.

The amount of Fragmin you receive will depend on your particular condition.

Haemodialysis/Haemofiltration Use in adults and the elderly:
If you are undergoing haemodialysis or
haemofiltration, the medicine will be injected into the tubes of the haemodialysis machine. For patients with chronic (long term) kidney problems, who are being given treatment lasting longer than 4 hours, a starting dose of 30-40 IU for each kg of bodyweight will usually be given. This is followed by an infusion (slow injection) of 10-15 IU/kg every hour. The same dose may be given if the treatment lasts less than 4 hours. For haemodialysis and haemofiltration lasting up to 4 hours, a single bolus injection of 5000 IU may also be either administered intravenously or into the tube of the dialysis machine. Your doctor may adjust the dose session to session.
For patients with acute (rapid or severe) kidney
failure, or patients who are more likely to bleed, the usual dose is 5-10 IU for each kg of body weight, followed by 4-5 IU/kg every hour.
Deep Vein Thrombosis
Use in adults and the elderly:
If you are having treatment for deep vein
thrombosis you will be given an injection beneath the skin. The site of this injection will usually be the stomach (abdomen) or outer aspects of your thigh. A dose of 200 IU for each kg of body weight may be given once a day, or 100 IU/kg twice a day.
The single daily dose should not exceed 18,000 IU.
Fragmin can be used together with other
blood thinning medicines known as Vitamin K antagonists. Should this be desired, a minimum of five days would be required.
- Unstable Coronary Artery Disease Use in adults and the elderly:
  In the treatment of unstable coronary artery disease, a dose of 120 IU/kg of body weight is given every 12 hours, as an injection beneath the skin. If you have an artificial heart valve, the normal dose for prevention of blood clots is not sufficient. Your doctor will discuss this with you.
  The maximum dose in a 12-hour period is 10,000 IU.
- Extended use
  If your doctor has recommended a special procedure to restore the blood supply to your heart (angiography or coronary artery surgery), it may be necessary to continue to administer Fragmin for up to 45 days. In this case, the dose should be either 5,000 IU (women less than 80 kg and men less than 70 kg) or 7,500 IU (women 80 kg and above or men 70 kg and over) every 12 hours. These are typical doses for adults, including elderly patients. Your doctor will work out the right dose for you. Some of the liquid in the syringe may have to be expelled before the injection is given.

Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.

Use in Children and Adolescents Treatment of blood clots in the veins (Symptomatic Venous
Thromboembolism - VTE)
The recommended dose depends on the child’s body weight and age group and will be calculated by your doctor. Your doctor will advise you about the individualised dose of Fragmin according to these criteria. Do not change the dosage and treatment schedule without consulting your doctor.
The following table shows the recommended starting dose for children and adolescents depending on their age:
Children 1 month to less than 2 years:
150 IU/kg twice daily.
Children 2 years to less than 8 years:
125 IU/kg twice daily.
Children 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 adjustment made using a blood test.

How to Inject Fragmin

Fragmin is given as an injection under the skin (subcutaneously).

When dilution is required before administering Fragmin to children, it should be performed by a healthcare professional. You should follow your doctor’s instructions on how and when to inject the diluted drug that is provided to you.

This section of the leaflet explains how you should inject Fragmin to yourself or to your child. You should follow these instructions only after you have been trained by your doctor. If you are not sure what to do, talk to your doctor immediately. You should inject (or give) the dose of Fragmin at the times recommended by your doctor.

Please follow the steps explained below

Step 1: How you prepare your syringe for injection will depend on specific Fragmin presentation that you will be using

If you are using Fragmin from a vial:

Collect together the items that you need: vial, syringe, alcohol swab or soap and water. The vial, syringe and needle all have protective covers. The flip-off cap on the vial can rotate; this is normal. Check that all the dalteparin sodium

Package leaflet: Information for the user Fragmin®

10,000 IU/4 ml Solution for injection

PAA244243

300

PUURS Time:

PAR Number

ITF / DM

Source Code

Market Layout

Description

16:10

18 Nov 2025

PAA244243 02 N/A

9 pt

PAR-2025-1007509

Data matrix - PAA244243

N/A

T_I139/Y_02_0

310 x 420 mm

PUURS

UNITED KINGDOM

Black Profile

Figure 6

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

After removing the bubbles, check the amount of drug in the syringe according to the dose markings on the side of the syringe barrel to make sure it is correct.

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

Step 2: Choosing and preparing the subcutaneous injection area

Choose one of the recommended injection sites below (see shaded areas Figure 7):

A “U” shaped area around the navel.

Side of the middle thighs.

Figure 7

Use a different site to inject each time a dose is
given.
Do not inject into areas where the skin is tender,
bruised, red, or hard. Avoid areas with scars.
If you or the child have psoriasis, do not inject
directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Wash and dry your hands.
Clean the injection site with a new alcohol swab,
using a circular motion. Allow the skin to dry thoroughly. Do not touch this area again before
giving the injection.

Step 3: Getting the right position

You or your child should be sitting or lying down for subcutaneous injection administration. If you are self-injecting, get yourself in a comfortable sitting down position where you can see your stomach (see Figure 8).

Figure 8

Step 4:

Using the thumb and forefinger, lift up 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 to an adult or yourself, hold the syringe above the folded skin keeping it at a right angle (i.e. vertically as in the diagram and not at an angle). Insert the needle into the skin until the needle is fully inserted (see Figure 9). covers are on firmly and if they are not on properly, do not use them. If a needle is bent do not use it.

Before you begin, make sure you know how much you are going to inject. Your doctor should have instructed you on the proper amount of solution to be administered. If the doctor has not given this instruction, please contact him/her.

Prepare the medication dose: Remove the plastic top from the top of the vial (if present). Do not remove the rubber stopper or aluminium 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 touch any surface (see Figures 1 and 2).

Figure 1 Figure 2

Draw the correct dose from the vial: Remove the syringe from the plastic or paper cover. Remove the cap covering the needle. Be careful not to touch the needle. With the vial in an upright position, push the needle straight down at a 90 degree angle 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 be pointing upward (see Figure 4).

Figure 4

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

Figure 5

Keep the vial upside down, with the needle in the vial pointed upward. Tap the syringe, or “flick” it with your fingertips. This helps move bubbles to the top of the syringe (see Figure 6).

Figure 9

If you are injecting Fragmin to a child, push the needle all the way into the skin with a quick, short motion, at an angle between 45° and 90° (see Figure 10).

Figure 10

Step 6:

Push the plunger all the way down at a slow, steady rate to deliver the correct dose. Keep pinching the fold of skin while you are injecting and then release the fold of skin and pull the needle out.

If there is any oozing of blood at the injection site, apply gentle pressure. Do not rub the injection site as this may encourage bruising.

Press a cotton ball over the injection site 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, activate the needle-trap

Place the plastic catcher against a hard, stable surface and with one hand pivot the syringe barrel upwards against the needle forcing the needle into the catcher where it locks in place.

Continue bending the needle until the syringe exceeds a 45-degree angle with the flat surface to render it permanently unusable.

Step 8:

Dispose of the syringe and needle into a sharps container. Keep your sharps bin out of reach of other people. When the sharps bin is almost full, dispose of it as instructed or speak to your doctor or nurse.

If you are given more Fragmin than you should

If you feel that you have been given more Fragmin than you should, inform your doctor or nursing staff immediately. Your doctor may want to give you an injection of protamine as an antidote.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Stop using Fragmin and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes)

Common side effects (may affect up to 1 in 10 people):
- A reversible decrease in the number of
  clotting cells (platelets) in your blood (Type I thrombocytopenia). This may make you bruise more easily
  - Increased levels of potassium in your blood
    (symptoms may include temporary muscle weakness, loss of feeling and changes in your heartbeat)
  - Bleeding at any site
  - Certain substances produced by your liver
    may increase
  - Pain and reactions at the site of injection
  - Haematoma – collection of blood under the skin
  - Uncommon side effects (may affect up to 1 in
    100 people):
    - Red skin rash and itchiness
    - Itching
    - Allergic reactions
    - Your bones may weaken and break more easily.
      This is known as osteoporosis and has been seen in patients using heparin for a long time
  - Rare side effects (may affect up to 1 in 1,000 people):
    - An immune system problem resulting
      in a severe decrease in the number of clotting cells (platelets) in your blood (Type II thrombocytopenia)
    - Alopecia (hair loss)
    - Painful skin lesions
  - Not known (frequency cannot be estimated from
    the available data):
    - Bleeding inside or around your brain, symptoms may include sudden severe headache
    - Bleeding behind your abdomen (stomach),
      symptoms may include a feeling of tenderness and swelling around your stomach
    - Bruising of the spine which may lead to back
      pain, tingling, numbness or weakness in your legs, bowel or bladder problems

Heparin products can cause hypoaldosteronism (characterised by the reduced secretion of aldosterone, a hormone produced by the adrenal cortex), which can lead to increased potassium levels in the blood (hyperkalaemia). Rarely, especially in patients with chronic renal failure and diabetes, clinically significant hyperkalaemia may occur.

If you have an artificial heart valve, treatment with Fragmin might not be sufficient to prevent a blood clot, and you might develop a clot in the heart valve.

The adverse reactions in children are expected to be the same as in adults, however there is only a little information about the possible side effects of long-term use in children.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fragmin

Keep this medicine out of the sight and reach of children.

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

Fragmin should not be used after the expiry date which is printed on the label and carton. The expiry date refers to the last day of that month.

Store below 25 °C.

Your doctor or nurse will store Fragmin in a safe place under the above conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fragmin contains

The active ingredient in Fragmin is dalteparin sodium. Each 4 ml vial contains 2,500 IU/ml (International Unit).

The other ingredients are water for injections and sodium chloride.

What Fragmin looks like and contents of the pack

Fragmin is a clear colourless or straw coloured solution in a vial. Each pack contains 10 vials.

Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Manufacturer

Pfizer Manufacturing Belgium

NV, Rijksweg 12, 2870 Puurs (Puurs-Sint-Amands), Belgium

This leaflet was last revised in 11/2025.

Ref: FR 22_0