FRAGMIN 15 000 IU/0.6ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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date:18-APR-14 11:10:50

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Package leaflet: Information for the user

RECTO

Fragmin®

10,000 IU/0.4 ml, 12,500 IU/0.5 ml, 15,000 IU/0.6 ml & 18,000 IU/0.72 ml
Solution for Injection
dalteparin sodium

8R3799
19

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 possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Fragmin is and what it is used for
What you need to know before you are given or use Fragmin
How Fragmin is given to you
Possible side effects
How to store Fragmin
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.
• Fragmin is used to treat blood clots (venous
thromboembolism) and to prevent their recurrence.
• 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.
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 or use 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 had 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
• 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 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.

• 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 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 treat blood clots (venous thromboembolism)
The recommended doses depend on your body weight and will
be calculated by your doctor. The usual dose used to treat
venous thromboembolism is 200 IU (international units) for every
kilogram you weigh once daily.The following table shows the
dose you will receive depending on your body weight:
Body Weight (kg)
< 46
46-56
57-68
69-82
≥ 83

Dose (IU)
7,500
10,000
12,500
15,000
18,000

Abbreviations: IU = International Unit
Your treatment will last for at least 5 days.
The maximum daily dose is 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.
Medical staff may take blood samples during your treatment to
monitor the effects of Fragmin.
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 previous table) 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 months 2-6
Body Weight (kg)
≤ 56
57 to 68
69 to 82
83 to 98
≥ 99

Dose (IU)
7,500
10,000
12,500
15,000
18,000

Abbreviations: IU = International Unit
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:

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.

Get yourself in a comfortable sitting
down position where you can see
your stomach.

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).

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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

code

8R3799

guidelines

TSE-I013F

dimensions

210x634/35

date

18-APR-14 GLA

country

ENGLAND

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.

single dose syringes sealed with a rubber stopper.

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.

Each pack contains 5 syringes.
Fragmin 15,000 IU/0.6 ml Solution for Injection is a clear,
colourless or straw-coloured solution and is supplied in pre-filled
single dose syringes sealed with a rubber stopper.

Step 6:

VERSO

Step 5:

Fragmin 18,000 IU/0.72 ml Solution for Injection is a clear,
colourless or straw-coloured solution and is supplied in pre-filled
single dose syringes sealed with a rubber stopper.
Each pack contains 5 syringes.

Each pack contains 5 syringes.

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.

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ, UK
Manufacturers
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium
Pfizer Service Company bvba
Hoge Wei 10
B-1930 Zaventem
Belgium
This leaflet was last revised in 03/2014.
Ref: FR 17_0

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 site of injection
• Haematoma – collection of blood 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 medicine 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.
Four strengths of Fragmin syringes are available.
Each syringe provides a single dose of dalteparin sodium.

Process Black

10,000 IU/0.4 ml Solution for Injection.
12,500 IU/0.5 ml Solution for Injection.
15,000 IU/0.6 ml Solution for Injection.
18,000 IU/0.72 ml Solution for Injection.
The other ingredients are water for injections and either sodium
hydroxide or hydrochloric acid (to balance the acidity of the
injection).
What Fragmin looks like and contents of the pack
Fragmin 10,000 IU/0.4 ml Solution for Injection is a clear,
colourless or straw-coloured solution and is supplied in pre-filled
single dose syringes sealed with a rubber stopper.
Each pack contains 5 syringes.
Fragmin 12,500 IU/0.5 ml Solution for Injection is a clear,
colourless or straw-coloured solution and is supplied in pre-filled

8R3799

code

8R3799

guidelines

TSE-I013F

dimensions

210x634/35

date

18-APR-14 GLA

country

ENGLAND

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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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