FRAGMIN 2500 IU SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

FRAGMIN 2500 IU SOLUTION
FOR INJECTION
(dalteparin sodium)

The name of you medicine is Fragmin 2500 IU Solution
for Injection but will be referred to as Fragmin
throughout this leaflet.
Fragmin is also available as the 5000 IU 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 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
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
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. 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 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 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 (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
57 to 68
69 to 82
83 to 98
≥ 99

7,500
10,000
12,500
15,000
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.
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.
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.

4. Possible side effects
Like all medicines, Fragmin 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 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
Keep 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 in Fragmin is dalteparin sodium.
Fragmin contains 2,500 IU (International units) of
dalteparin sodium in 0.2 ml of solution.
The other ingredients are Water for Injection and
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 0.2ml of dalteparin sodium solution.
10 syringes are packed in each box.
Manufactured by Pfizer Manufacturing Belgium NV/SA,
Rijksweg 12, Puurs, B-2870 Belgium or Catalent France
Limoges SAS, Zone Industrielle Nord, Rue de Dion
Bouton, Limoges F-87280, France and procured from
within the EU and repackaging in the UK by the Parallel
Import Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Hertfordshire
WD6 1EE.
PL 20492/0420

Fragmin 2500 IU Solution for Injection.

Date of Preparation: 08th July 2013

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

DALTEPARIN SODIUM 2500 IU
SOLUTION FOR INJECTION
The name of you medicine is Dalteparin Sodium 2500 IU
Solution for Injection but will be referred to as Dalteparin
Sodium throughout this leaflet.
Dalteparin sodium is also available as the 5000 IU
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 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 Dalteparin Sodium is and what it is used for
2. What you need to know before you are given or use
Dalteparin Sodium
3. How Dalteparin Sodium is given to you
4. Possible side effects
5. How to store Dalteparin Sodium
6. Contents of the pack and other information

1. What Dalteparin Sodium is and what
it is used for
Dalteparin Sodium is a solution for injection. Its active
ingredient is dalteparin sodium.
Dalteparin Sodium 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.
• Dalteparin Sodium 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 Dalteparin Sodium.

2. What you need to know before you
are given or use Dalteparin Sodium
You should not be given Dalteparin Sodium:
• if you are allergic (hypersensitive) to the active
ingredient dalteparin sodium or a similar product or any
of the other ingredients of Dalteparin Sodium.
• 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 Dalteparin Sodium 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 Dalteparin
Sodium:
• 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 Dalteparin Sodium:
• 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
Dalteparin Sodium.
Other medicines and Dalteparin Sodium
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 Dalteparin Sodium
works, or Dalteparin Sodium itself can reduce the
effectiveness of other medicines taken at the same time.
Medicines that increase the effect of Dalteparin Sodium
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 Dalteparin
Sodium 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 Dalteparin
Sodium 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 Dalteparin
Sodium 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
Dalteparin Sodium 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.
Dalteparin Sodium is not recommended for the
prevention of blood clots on artificial heart valves during
pregnancy.
If you are receiving Dalteparin Sodium 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
Dalteparin Sodium does not affect the ability to drive and
operate machinery.

3. How Dalteparin Sodium 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
Dalteparin Sodium). The amount of Dalteparin Sodium
you receive will depend on your body weight.
Dalteparin Sodium 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 (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 Dalteparin Sodium 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
Dalteparin Sodium 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 26).
Dose of Dalteparin Sodium 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 Dalteparin Sodium during months 2-6
Body Weight (kg)
Dose (IU)
≤ 56
57 to 68
69 to 82
83 to 98
≥ 99

7,500
10,000
12,500
15,000
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 Dalteparin
Sodium for a short period.
Medical staff may take blood samples during your
treatment to monitor the effects of Dalteparin Sodium.
How to Inject Dalteparin Sodium
This section of the leaflet explains how you should go
about injecting Dalteparin Sodium 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.
Dalteparin Sodium is given by a small injection under the
skin. You should inject (or give) the dose of Dalteparin
Sodium at the time recommended by your doctor. Please
follow the steps explained below.
• Gather the single dose Dalteparin Sodium 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.
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 Dalteparin Sodium
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.
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
Dalteparin Sodium 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 Dalteparin Sodium.
If you are given more Dalteparin Sodium than you
should
If you feel that you have been given more Dalteparin
Sodium than you should, inform your doctor or nursing
staff immediately. Your doctor may initiate measures to
decrease the risk of bleeding.

4. Possible side effects
Like all medicines, Dalteparin Sodium can cause side
effects, although not everybody gets them.
Stop using Dalteparin Sodium 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
Dalteparin Sodium 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 Dalteparin Sodium
Keep out of the sight and reach of children.
Dalteparin Sodium 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 Dalteparin Sodium 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 Dalteparin Sodium contains
The active ingredient in Dalteparin Sodium is dalteparin
sodium. Dalteparin Sodium contains 2,500 IU
(International units) of dalteparin sodium in 0.2 ml of
solution.
The other ingredients are Water for Injection and Sodium
chloride.
What Dalteparin Sodium looks like and contents of
the pack
Dalteparin Sodium is available as a clear, colourless or
straw coloured solution in pre-filled single dose syringes,
each containing 0.2ml of dalteparin sodium solution.
10 syringes are packed in each box.
Manufactured by Pfizer Manufacturing Belgium NV/SA,
Rijksweg 12, Puurs, B-2870 Belgium or Catalent France
Limoges SAS, Zone Industrielle Nord, Rue de Dion
Bouton, Limoges F-87280, France and procured from
within the EU and repackaging in the UK by the Parallel
Import Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Hertfordshire
WD6 1EE.
PL 20492/0420
for Injection.

Dalteparin Sodium 2500 IU Solution

Date of Preparation: 08th July 2013

POM

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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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