FRAGMIN 7 500 IU/0.3 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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Package leaflet: Information for the user

Fragmin® 7500 IU/0.3ml Solution for Injection
(dalteparin sodium)
The name of this product is Fragmin® 7500 IU/0.3ml
Solution for Injection but will be referred to as Fragmin
throughout this leaflet.
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. If your doctor
has given you this medicine to use at home do not pass it
on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects talk to your doctor, nurse or
pharmacist. This includes 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.
• 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.
• Fragmin is also used to treat a condition known as
unstable coronary artery disease. In coronary artery
disease the coronary arteries (blood vessels to the heart)
are furred up and narrowed by patches of fatty deposits.
• Unstable coronary artery disease means that a furred up
bit of the artery has ruptured and a clot has formed on it,
reducing the flow of blood to the heart. Patients with this
condition may be more likely to go on to have a heart
attack without treatment with blood thinning drugs such as
Fragmin.

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).

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

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

2. What you need to know before you are
given or use Fragmin

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

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 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
• 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 artificial heart
valves.
• if you need any other injections.

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 treat blood clots (venous thromboembolism)
• Deep Vein Thrombosis
The usual dose of Fragmin used to treat deep vein
thrombosis is 200 IU (units) for every kilogram you weigh,
given once a day. Your doctor will select the dose which is
appropriate for you based on your bodyweight.
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
Abbreviations: IU = International Unit
The maximum daily dose is 18,000 IU.

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

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.
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)
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.

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.
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

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.

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)

In some cases of decreased platelet count (clotting cells),
your doctor may interrupt your treatment with Fragmin for a
short period.

- 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 site of injection
• Haematoma – collection of blood under the skin

Medical staff may take blood samples during your treatment
to monitor the effects of Fragmin.
• Unstable Coronary Artery Disease
The usual dose used to treat unstable coronary artery
disease is 120 IU (units) for every kilogram you weigh,
given every 12 hours.
The maximum dose in a 12 hour period is 10,000 IU (units).
Doses are usually given for between 5 and 8 days.
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.
• Extended use Adults and the Elderly
If your doctor has recommended a special procedure to
restore the blood supply to your
heart (angiography or coronary artery surgery), it may be
necessary to continue to administer Fragmin for up to 45
days. In this case, the typical dose for adults, including
elderly patients should be either 5,000 IU (units) (women
less than 80 kg and men less than 70 kg) or 7,500 IU
(women 80 kg and above and men 70 kg and over) every
12 hours.
The maximum dose in a 12 hour period is 10,000 IU.
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, 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.

- 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) cells (platelets)
• 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 25oC.
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.

6. Contents of the pack and other
information
What Fragmin contains
The active ingredient in Fragmin is dalteparin sodium.
Each syringe contains: Active ingredient: dalteparin sodium
7,500 IU (anti-factor Xa) in 0.3 ml isotonic solution.
The other ingredients are water for injections and either
sodium hydroide or hydrochloric acid (to balance the acidity
of the injection).
What Fragmin looks like and contents of the pack
Clear colourless solution and is supplied in a single dose
pre-filled syringes with a grey latex-free needle stopper
Each pack contains 10 syringes.
Procured from within the EU by PL Holder PilsCo Ltd, 9-15
Springburn Place, East Kilbride, G74 5NU.
PL39467/0125 Fragmin 7500 IU/0.3ml Solution for Injection
Manufacturers
Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs, B2870, Belgium
Catalent France Limoges S.A.S., 87 rue de Dion Bouton,
Limoges, F-87000, France
This leaflet was last revised in 07/10/2013
®Registered trademark of Pfizer Health AB

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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