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DALTEPARIN SODIUM 5 000 IU/0.2ML SOLUTION FOR INJECTION

Active substance(s): DALTEPARIN SODIUM

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Package leaflet: Information for the user
®

Fragmin 5,000 IU/0.2ml Solution for Injection
Dalteparin sodium 5,000 IU/0.2ml Solution for Injection
(dalteparin sodium)
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• This medicine has been prescribed for you only. If your doctor has
given you this medicine to use at home do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section
4.
• Your medicine is available using either of the above names but will be
referred to as Fragmin throughout the remainder of this leaflet.
• Fragmin is available in other strengths.
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.

Other medicines and Fragmin
Tell your doctor, pharmacist or nurse if you are taking, have recently
taken or are planning to take or use any other medicines. This includes
medicines that you have bought for yourself.
Some medicines can affect the way Fragmin works, or Fragmin itself can
reduce the effectiveness of other medicines taken at the same time.
Medicines that increase the effect of Fragmin include:
• Those used to thin your blood (e.g. aspirin, dipyridamole, glycoprotein
receptor antagonists and warfarin).
• Medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used
to reduce pain and inflammation (e.g. indometacin).
• Some medicines for gout (e.g. sulfinpyrazone and probenecid).
• Etacrynic acid (a water retention tablet (diuretic)).
• Solutions given to increase the blood volume (e.g. dextrans).
• Medicines known as cytostatics (used in cancer treatment).
• Thrombolytic medications for treating transmural heart attack
(e.g. TPA-tissue plasminogen activator).
Medicines that can reduce the effect of Fragmin include:
• Those for allergy and hay fever (e.g. antihistamines).
• Those used for heart or circulation problems (e.g. digoxin or digitoxin).
• Antibiotics known as tetracyclines which are used to treat bacterial
infections.
• Vitamin C (e.g. some vitamin supplements).
Other medicines that may interfere with Fragmin include:
• Those used to treat angina (intravenous nitroglycerine)
• Antibiotics such as high dose penicillin which are used to treat
bacterial infections
• Anti-malarials (e.g. quinine)
• Tobacco smoking.
Please note that if you are being treated with Fragmin for unstable
coronary artery disease your doctor may adjust your dose of aspirin
accordingly.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other low molecular weight heparins or anti-thrombotics.
Pregnancy and breast-feeding
Fragmin has not been found to cause harmful effects during pregnancy.
The possibility of harm to the baby appears remote. Tell your doctor if
you are pregnant and they will advise you. Fragmin is not recommended
for the prevention of blood clots on artificial heart valves during
pregnancy.
If you are receiving Fragmin to treat blood clots, you should not have a
local, spinal or epidural anaesthetic.

2. What you need to know before you are given or use Fragmin
You should not be given Fragmin:
• if you are allergic (hypersensitive) to the active ingredient dalteparin
sodium or a similar product or any of the other ingredients of this
medicine (listed in section 6).
• if you have an active stomach ulcer or ulcer of the duodenum (small
intestine).
• if you have suffered from a brain haemorrhage (bleeding in your brain).
• if you have fluid mixed with blood that appears around heart and lungs.
• if you suffer from any condition which may cause you to bleed more
easily (e.g. haemophilia, liver failure). Ask your doctor if you are
unsure.
• if you have a condition called septic endocarditis (an infection and
inflammation of the lining of the heart and heart valves). Your doctor
will have told you if you have this.
• if you have had a condition called “heparin-induced thrombocytopenia”
(a decrease in the number of clotting cells (platelets) in your blood
caused by heparin, which may cause you to bruise and bleed more
easily). Your doctor will have told you if you have this.
• if you have an injury to, or have had an operation involving your spine,
head, eyes or ears.
If you are receiving Fragmin to treat blood clots, you should not have a
local, spinal or epidural anaesthetic.
If you are given this medicine as part of your cancer treatment your
doctor will check that you weigh more than 40 kg, and that you have not
had a stroke within the last 3 months.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given or use
Fragmin:
• if you have conditions which make you more susceptible to bleeding
e.g.:
• after an operation or trauma
• a stroke caused by a bleed
• a brain tumour
• severe liver or kidney failure
• abnormal or low numbers of platelets (clotting cells)
• eye disease caused by blood pressure or diabetes
• taking other medicines that thin the blood (e.g. aspirin, warfarin,
dipyridamole)
• uncontrolled high blood pressure.
• if you have been told by your doctor that you have a lot of potassium in
your blood or have a low blood pH. Your doctor will monitor your blood
regularly before and during treatment.
• if you have ever had an operation to insert an artificial heart valve.
• if you need to have any other injections.
You may need to have blood tests to monitor the effects of Fragmin:
• if you have kidney failure or liver problems
• if you are very thin or morbidly obese
• if you are pregnant
• if you are at increased risk of bleeding or rethrombosis (more blood
clots)
• if you are a child
• if you have blood problems due to cancer treatment.
Children and adolescents
Dosing recommendations in children are based on clinical experience;
there are limited data from clinical trials, which will help your doctor
calculate the dose of Fragmin.

Ask your doctor or pharmacist for advice before being given or using this
medicine whilst breast-feeding.
Driving and using machines
Fragmin does not affect the ability to drive and operate machinery.
3. How Fragmin is given to you
Your medicine will usually be administered by a doctor or nurse or you
may be shown how to give the injection yourself at home (See Section on
How to Inject Fragmin). The amount of Fragmin you receive will depend
on your body weight.
Fragmin is given as a single, once daily, subcutaneous injection, which
means it is injected beneath the skin. It is usually injected into a skin fold
in your abdomen (stomach), or the outer aspects of your thigh. It should
not be injected into your muscles.
Use in adults and the elderly
To prevent blood clots (venous thromboprophylaxis)
• Patients with a moderate risk of developing a clot:
The recommended dose is 2,500 IU one to two hours before the
operation, then 2,500 IU each morning. This is continued for five to
seven days, or until you are fully able to move about.
• Patients with a greater risk of developing a clot e.g. those who
have had clots in the past:
For this type of patient, the recommended dose is 2,500 IU one to two
hours before the operation, the same dose 8 to 12 hours later, then
5,000 IU each morning. As an alternative, 5,000 IU may be given the
evening before the operation, then 5,000 IU on following evenings. The
first dose (2,500 IU) may also be given as soon as possible after your
operation and is to be continued for five to seven days, or until you are
able to move about.
• Hip Replacement Surgery
After a hip operation, your doctor may decide to continue treating you
with Fragmin for five weeks using a dose of 5,000 IU every evening. If
you have an artificial heart valve, the normal dose for prevention of
blood clots is not sufficient. Your doctor will discuss this with you.
• The maximum dose you will be given in a 12 hour period is
10,000 IU.
• If you are bedridden due to illness, the dose of Fragmin given will be
5,000 IU daily. The length of treatment will be up to 14 days,
depending on your illness.
These are typical doses for adults, including elderly patients. Your doctor
will work out the right dose for you. Some of the liquid in the syringe may
have to be expelled before the injection is given.
To treat blood clots (venous thromboembolism) in certain types of
cancer and prevent recurrence
The usual dose used to treat venous thromboembolism in cancer is
200 IU (international units) for every kilogram you weigh (see table
overleaf) 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)
< 46
46-56
57-68
69-82
≥ 83

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:
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 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.
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.
Dispose of the syringe in the yellow sharps bin provided. Keep your
sharps bin out of reach of other people. When the sharps bin is almost
full please speak to your doctor or nurse.
Children and adolescents
The dose will be based on both the child’s age and weight. Younger
children may need slightly more Fragmin per kg than adults. Your doctor
will work out the right dose for you. Medical staff may take blood samples
during your treatment to monitor the effects of Fragmin.
If you are given more Fragmin than you should
If you feel that you have been given more Fragmin than you should,
inform your doctor or nursing staff immediately. Your doctor may initiate
measures to decrease the risk of bleeding.
If you forget to use Fragmin
Tell your doctor or pharmacist if you think that a dose has been forgotten.
A double dose should not be given to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop using Fragmin and talk to a doctor or nurse at once if you get any
signs of a severe allergic reaction (such as difficulty breathing, swelling of
the lips, mouth, throat or eyes)
- Common side effects (may affect up to 1 in 10 people):
• A reversible decrease in the number of clotting cells (platelets) in
your blood (Type I thrombocytopenia). This may make you bruise
more easily.
• Bleeding at any site
• Certain substances produced by your liver may increase
• Pain and reactions at the injection site
• Haematoma – you may notice blood collecting under the skin
- Uncommon side effects (may affect up to 1 in 100 people):
• Increased levels of potassium in your blood (symptoms may include
temporary muscle weakness, loss of feeling and changes in your
heartbeat)
• Red skin rash and itchiness
• Itching
• Allergic reactions
- Rare side effects (may affect up to 1 in 1,000 people):
• An immune system problem resulting in a severe decrease in the
number of clotting cells (platelets) in your blood (Type II
thrombocytopenia)
• Alopecia (hair loss)
• Painful skin lesions
- Not known (frequency cannot be estimated from the available data):
• Bleeding inside or around your brain, symptoms may include
sudden severe headache
• Bleeding behind your abdomen (stomach), symptoms may include a
feeling of tenderness and swelling around your stomach
• Bruising of the spine which may lead to back pain, tingling,
numbness or weakness in your legs, bowel or bladder problems
If you have an artificial heart valve, treatment with Fragmin might not be
sufficient to prevent a blood clot, and you might develop a clot in the
heart valve.
The adverse reactions in children are expected to be the same as in
adults, however there is only a little information about the possible side
effects of long term use in children.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Fragmin
• Keep 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.
• Do not store above 25oC.
• Your doctor or nurse will store Fragmin in a safe place under the
above conditions.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 5,000 IU
(anti-factor Xa) in 0.2 ml isotonic solution.
The other ingredients are: Water for injections, sodium hydroxide or
hydrochloric acid for pH adjustment.
Contains no preservative.
What Fragmin looks like and contents of the pack
Fragmin 5,000 IU/0.2 ml Solution for Injection is a clear, colourless
solution and is supplied in a 0.5ml glass single dose pre-filled syringes
with a latex-free grey needle shield.
Each pack contains 10 syringes.
Manufacturer
Fragmin is manufactured by:
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
Catalent France Limoges S.A.S., Z.I. Nord, 87 rue de Dion Bouton,
87000 Limoges, France.
Product Licence Holder
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK
Repackaged by MPT Pharma Ltd.
Leaflet dated 26th January 2015
Leaflet coded xxxxxxxxx

POM

PL: 33532/0474 Fragmin® 5,000 IU/0.2ml Solution for Injection
Dalteparin sodium 5,000 IU/0.2ml Solution for Injection
Fragmin® is a registered trademark of Pfizer Health AB

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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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