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FRAGMIN 2 500 IU/ 0.2ML SOLUTION FOR INJECTION

Active substance(s): DALTEPARIN SODIUM

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Package leaflet: Information for the user

Fragmin

®

dalteparin sodium



2,500 IU/0.2 ml & 5,000 IU/0.2 ml
Solution for Injection

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,
pharmacist or nurse.
• This medicine has been prescribed for you only. 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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 this medicine (listed in
section 6).
• if you have an active stomach ulcer or ulcer of the
duodenum (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 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 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
Talk to your doctor, pharmacist or nurse 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. TPA-tissue 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 weight
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 being
given or using 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 outer aspects 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 (2,500 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

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

Dose (IU)

≤ 56

7,500

57 to 68

10,000

69 to 82

12,500

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.

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6. Contents of the pack and other
information

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.

What Fragmin contains

The active ingredient in Fragmin is dalteparin sodium. Two
strengths of Fragmin syringes are available, containing
either 2,500 IU (International units) or 5,000 IU of dalteparin
sodium in 0.2 ml of solution.

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.

The other ingredients are water for injections and in the
2,500 IU product, sodium chloride.

What Fragmin looks like and contents of the
pack

Fragmin is available as a clear, colourless or straw coloured
solution in pre-filled single dose syringes, each containing
0.2 ml of dalteparin sodium solution.
10 syringes are packed in each box.

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ, UK

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium

Step 6:

Catalent France Limoges S.A.S
Z.I. Nord
87 rue de Dion Bouton
87000 Limoges
France

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.

This leaflet was last revised in 03/2014
Ref: FR 17_0

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.

Step 7:

C
LI
C
K
!

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

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.

If you forget to use Fragmin

Tell your doctor or pharmacist if you think that a dose has
been forgotten.
A double dose should not be given to make up for a
forgotten dose.
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.
• 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 (may affect up to 1 in 100 people):
• 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 (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
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
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.
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.

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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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