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DALTEPARIN SODIUM 7 500 IU/0.3ML SOLUTION FOR INJECTION

Active substance(s): DALTEPARIN SODIUM

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Package Leaflet: Information for the User
®

Fragmin 7,500 IU/0.3ml Solution for Injection /
Dalteparin Sodium 7,500 IU/0.3ml 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 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® / Dalteparin Sodium Solution for Injection is also available in
other strengths and as a vial.
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.

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).

• 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.

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.

• 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.

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

• 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.
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

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.

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 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 receiving Fragmin to treat blood clots, you should not have a
local, spinal or epidural anaesthetic.

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.

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 artificial heart valves.
• 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.

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.

The following table shows the dose you will receive depending on your
body weight:
Body Weight (kg)
Dose (IU)
< 46
7,500
46-56
10,000
57-68
12,500
69-82
15,000
≥ 83
18,000
Abbreviations: IU = International Unit
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.
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
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.
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 ris
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 monito
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, inclu
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 a
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
lood 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.
r. 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
urself 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
bove 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 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
numbe 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
n 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
b
(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,
brain symptoms may include
sudden severe headache
• Bleeding behind your abdomen (stomach),
(stomach) symptoms may include a
feeling of tenderness and swelling
ing 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 stamped on
the pack.. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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.
sodium
Each single dose pre-filled
filled syringe contains the active ingredient
dalteparin sodium 7,500 IU (anti-factor
factor Xa) in 0.3ml of isotonic solution.
The other ingredients are:
Water for injections and sodium hydroxide or hydrochloric acid (for pH
adjustment).
What Fragmin looks like and contents of the pack
Fragmin 7,500 IU/0.3ml
3ml Solution for Injection is a single dose syringe
containing solution for injection for subcutaneous administration.
Fragmin 7,500 IU/0.3ml
ml Solution for Injection is a clear, colourless
solution contained in a single dose pre-filled
filled syringe with a dark grey
rubber stopper.
Each pack contains 10 syringes.

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.

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.

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
e effects of Fragmin.

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

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.

PL: 33532/0409

Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx
POM

nd

Leaflet date: 2 October 2014
Leaflet code: xxxxxxxxx
Fragmin® is a registered trademark of xxxxxxxxxxxxxxxxxxxx

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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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