FRAGMIN 5 000 IU/0.2 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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Fragmin 2,500 IU/0.2 ml Solution for Injection/
Fragmin 5,000 IU/0.2 ml Solution for Injection
(dalteparin sodium)
Your medicine is known by the any of the above names, but will be
referred to as Fragmin throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. If your doctor has given you
this medicine to use at home do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1) What Fragmin is and what it is used for
2) What you need to know before you are given or use Fragmin
3) How Fragmin is given to you
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 is a solution for injection. Its active ingredient is dalteparin
sodium.
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.
Venous thromboembolism is a condition where blood clots develop in the
legs (deep vein thrombosis) or the lungs (pulmonary embolism), e.g. after
surgery, prolonged bed rest or in patients with certain types of cancer.
 Fragmin is used to prevent blood clots (venous thromboembolism)
forming before and after an operation or if you are bedridden due to
illness and to prevent their recurrence.
The 5000 IU product can also be used for:
 Prevention of deep vein thrombosis in patients bedridden due to a
medical condition but not limited to, for example heart failure and
respiratory failure.
 Treatment of patients with solid tumours who suffer from low platelet
counts.
Ask your doctor if you are unsure why you have been given Fragmin.

2) What you need to know before you are given or use
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 Fragmin.
 if you have an active stomach ulcer or ulcer of the duodenal (small
intestine).
 if you have suffered from a brain haemorrhage (bleeding in your brain).
 if you have fluid mixed with blood that appears around heart and lungs.
 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 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 had a condition called “heparin-induced thrombocytopenia” (a
decrease in the number of clotting cells (platelets) in your blood caused
by heparin, which may cause you to bruise and bleed more easily). Your
doctor will have told you if you have this.
 if you have an injury to, or have had an operation involving your spine,
head, eyes or ears.
If you are receiving Fragmin to treat blood clots, you should not have a
local, spinal or epidural anaesthetic.
If you are given this medicine as part of your cancer treatment your doctor
will check that you weigh more than 40 kg, and that you have not had a
stroke within the last 3 months.
Warnings and precautions
Tell your doctor before you are given or use 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
 a brain tumour
 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 an artificial heart valve.
 If you need to have 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
 If you have blood problems due to cancer treatment.
Children and adolescents
Dosing recommendations in children are based on clinical experience;
there are limited data from clinical trials, which will help your doctor
calculate the dose of Fragmin.

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:
 Those used to thin your blood (e.g. aspirin, dipyridamole, glycoprotein
receptor antagonists and warfarin).
 Medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to
reduce pain and inflammation (e.g. indometacin).
 Some medicines for gout (e.g. sulfinpyrazone and probenecid).
 Etacrynic acid (a water retention tablet (diuretic)).
 Solutions given to increase the blood volume (e.g. dextrans).
 Medicines known as cytostatics (used in cancer treatment).
 Thrombolytic medications for treating transmural heart attack (e.g. TPAtissue plasminogen activator).
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).
Other medicines that may interfere with Fragmin include:
 Those used to treat angina ( 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 heparins or anti-thrombotics.
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.
Fragmin is not recommended for the prevention of blood clots on artificial
heart valves during pregnancy.
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.

3) How Fragmin is given to you
Your medicine will usually be administered by a doctor or nurse or you
may be shown how to give the injection yourself at home (See Section on
How to Inject Fragmin). The amount of Fragmin you receive will depend on
your body weight.
Fragmin is given as a single, once daily, subcutaneous injection, which
means it is injected beneath the skin. It is usually injected into a skin fold in
your abdomen (stomach), or the upper part of your thigh. It should not be
injected into your muscles.
Use in adults and the elderly
To prevent blood clots (venous thromboprophylaxis)
 Patients with a moderate risk of developing a clot:
The recommended dose is 2,500 IU one to two hours before the
operation, then 2,500 IU each morning. This is continued for five to
seven days, or until you are fully able to move about.
 Patients with a greater risk of developing a clot e.g. those who have
had clots in the past:
For this type of patient, the recommended dose is 2,500 IU one to two
hours before the operation, the same dose 8 to 12 hours later, then
5,000 IU each morning. As an alternative, 5,000 IU may be given the
evening before the operation, then 5,000 IU on following evenings. The
first dose (2500 IU) may also be given as soon as possible after your
operation and is to be continued for five to seven days, or until you are
able to move about.
 Hip Replacement Surgery
After a hip operation, your doctor may decide to continue treating you
with Fragmin for five weeks using a dose of 5,000 IU every evening. 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 you will be given in a 12 hour period is 10,000 IU.
 If you are bedridden due to illness, the dose of Fragmin given will be
5,000 IU daily. The length of treatment will be up to 14 days, depending
on your illness.
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.
To treat blood clots (venous thromboembolism) in certain types of
cancer and prevent recurrence
The usual dose used to treat venous thromboembolism in cancer is 200 IU
(international units) for every kilogram you weigh (see table below) once
daily during the first month after a thromboembolic event (blood clot),
followed by 150 IU for every kilogram you weigh (during months 2-6).

Dose of Fragmin during month 1
Body weight (kg)

Dose (IU)

< 46

7,500

46-56

10,000

57-68

12,500

69-82

15,000

≥ 83

18,000

Dispose of the syringe in the yellow sharps box provided. Keep your
sharps box out of reach of other people. When the sharps box is almost full
please speak to your doctor or nurse.

Dose of Fragmin during months 2-6
Body Weight (kg)

Dose (IU)

Children and adolescents
 The dose will be based on both the child’s age and weight. Younger
children may need slightly more Fragmin per kg than adults. Your doctor
will work out the right dose for you. Medical staff may take blood
samples during your treatment to monitor the effects of Fragmin.
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 initiate
measures to decrease the risk of bleeding.

≤ 56

7,500

57 to 68

10,000

4) Possible side effects

69 to 82

12,500

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

83 to 98

15,000

≥ 99

18,000

This treatment course is not recommended for patients weighing less than
40 kg.
The maximum daily dose is 18,000 IU. The recommended duration of
treatment is 6 months. If you are suffering from severe kidney disease or a
decreased platelet count (clotting cells) caused by chemotherapy or
another condition with an elevated bleeding risk, your doctor will adjust this
dose accordingly.
In some cases of decreased platelet count (clotting cells), your doctor may
interrupt your treatment with Fragmin for a short period.
Medical staff may take blood samples during your treatment to monitor the
effects of Fragmin.
How to Inject Fragmin
This section of the leaflet explains how you should go about injecting
Fragmin yourself, but you should only do so if you have been given
permission by your doctor. It is a simple process and one that you can do
at home.
Fragmin is given by a small injection under the skin. You should inject (or
give) the dose of Fragmin at the time recommended by your doctor. Please
follow the steps explained below.
 Gather the single dose Fragmin syringe and the yellow sharps bin.
 Wash and dry your hands. The injection site should be cleaned.
Please note that if a carer is doing the injecting, it is recommended that
they wear gloves to perform the injection.
Step 1:
Get yourself in a comfortable sitting down
position where you can see your stomach.

Step 2:
Choose an injection site either on your
stomach or outer aspects of your left or right
thigh (see shaded areas). Your stomach is
usually best as the injection site and it is
important that you change the site each time.

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 which may affect more than 1 person in 100 are
listed below:
 A reversible decrease in the number of clotting cells (platelets) in your
blood (Type I thrombocytopenia). This may make you bruise more
easily.
 Bleeding at any site
 Certain substances produced by your liver may increase
 Pain and reactions at the injection site
 Haematoma – you may notice blood collecting under the skin
- Uncommon side effects which may affect more than 1 person in 1, 000
are listed below:
 Increased levels of potassium in your blood (symptoms may include
temporary muscle weakness, loss of feeling and changes in your
heartbeat)
 Red skin rash and itchiness
 Itching
 Allergic reactions
- Rare side effects which may affect more than 1 person in 10, 000 are
listed below:
 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
The following additional side effects have been reported but it is not known
how often they happen:
 Bleeding inside or around your brain
 Bleeding behind your abdomen (stomach)
 Bruising of the spine which may lead to back pain, tingling, numbness
or weakness in your legs, bowel or bladder problems
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.

5) How to store Fragmin

Step 3:
Pick up the syringe, grasp the tip of the plastic
needle catcher and bend it away from the shield.
Remove the grey rubber cover by pulling it straight
off. You will notice an air bubble in the syringe. It is
supposed to be there and you can just ignore it. It is
important not to press the plunger just yet as some
of the medicine may be lost.
Step 4:
Hold the syringe in one hand and with the other
hand, gently pinch a fold of skin with its fatty tissue (see the shaded areas
above) between your thumb and index finger. This will be the injection site.
Step 5:
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.
Step 6:
Now press the plunger and inject the
Fragmin slowly until all of the medicine has
been injected. 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.
Step 7:
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.

 Keep all medicines out of the sight and reach of children.
 Fragmin should not be used after the expiry date which is stamped on
the pack. The expiry date refers to the last day of that month.
 Do not store above 25°C.
 Your doctor or nurse will store Fragmin in a safe place under the above
conditions.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Contents of the pack and other information
What Fragmin contains:
The active ingredient is dalteparin sodium.
Two strengths of Fragmin pre-filled syringes are available containing either
2,500 IU (International units) or 5,000 IU of dalteparin sodium in 0.2 ml of
isotonic solution.
Fragmin 2,500 IU (anti-factor Xa) in 0.2ml of isotonic solution also contains
water for injections, sodium chloride, and sodium hydroxide or hydrochloric
acid (for pH adjustment).
Fragmin 5,000 IU (anti-factor Xa) in 0.2ml of isotonic solution also contains
water for injections, and sodium hydroxide or hydrochloric acid (for pH
adjustment).
What Fragmin looks like and contents of the pack
Fragmin is available as a clear, colourless or straw coloured solution and is
supplied in pre-filled single dose syringes sealed with a rubber stopper.
10 syringes are packed in each box.
PL 10383/1956 Fragmin 2,500 IU/0.2 ml Solution for Injection POM
PL 10383/1957 Fragmin 5,000 IU/0.2 ml Solution for Injection POM
Who makes and repackages your medicine?
Your medicine is manufactured by Catalent France Limoges S.A.S.
Z.I. Nord, 87 rue de Dion Bouton, 87000 Limoges France or Pfizer
Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium. Procured
from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 22.03.2013.
Fragmin® is a registered trademark of the Pfizer group of companies.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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