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FRAGMIN 5 000 IU /0.2ML SOLUTION FOR INJECTION

Active substance(s): DALTEPARIN SODIUM

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Assessed against UK PIL dated March 2014
By rajeevkumarj at 3:55 pm, Jun 11, 2015

PACKAGE LEAFLET: INFORMATION FOR THE USER
Fragmin® 5,000 IU/0.2ml solution for injection
(dalteparin sodium)
Your medicine is called Fragmin® 5,000 IU/0.2ml solution for
injection but will be referred to as Fragmin throughout the
remainder of this leaflet.
This medicine is also available in other strengths.
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, nurse or pharmacist. 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.

MOCK-UP

• 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

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.

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

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

Pregnancy and breast-feeding

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
S0541-CR-PIL-11.06.2015

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

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

Dose of Fragmin during month 1
Body Weight (kg)
<46
46-56
57-68
69-82
≥83

If you forget to use Fragmin
Dose (IU)
7,500
10,000
12,500
15,000
18,000

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

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:

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.
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
• 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.

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

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.

Step 2:

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

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 and 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.

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

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.

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.

Step 5:

6. Contents of the pack and other information

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.

What Fragmin contains

Step 6:

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

Step 4:

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.
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.

Each syringe contains: Active ingredient, dalteparin sodium in 5000 IU
(anti-factor Xa) in 0.2 ml isotonic solution.
The other ingredients are: water for injections, sodium hydroxide and
hydrochloric acid.

What Fragmin looks like and contents of the pack

Manufactured by: Pfizer Manufacturing Belgium N.V., Rijksweg 12,
2870 Puurs, Belgium or Catalent France Limoges S.A.S., Z.I. Nord 87 rue
de Dion Bouton, 87000 Limoges, France
Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma
Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9
6AQ.
POM

PL 33902/0541

Leaflet revision date: 11/06/2015
Fragmin® is a registered trademark of Pfizer Health AB.
S0541-CR-PIL-11.06.2015

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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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