FRAGMIN 18 000 IU/0.72 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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Fragmin 10,000 IU/0.4 ml Solution for Injection/
Fragmin 12,500 IU/0.5 ml Solution for Injection/
Fragmin 15,000 IU/0.6 ml Solution for Injection/
Fragmin 18,000 IU/0.72 ml Solution for Injection
(dalteparin sodium)
Your medicine is known by any of the above names, but will be referred to
as Fragmin throughout this:
Patient Information 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.
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.
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:
 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 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
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 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 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).
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 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 taking 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)
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)

Dose (IU)

< 46

7,500

46-56

10,000

57-68

12,500

69-82

15,000

≥ 83

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)

Dose (IU)

≤ 56

7,500

57 to 68

10,000

69 to 82

12,500

83 to 98

15,000

≥ 99

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

 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)
 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 all medicines 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.

6) Contents of the pack and oher information
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.

What Fragmin contains:
The active ingredient is dalteparin sodium.
Four strengths of Fragmin syringes are available.
Each pre-filled syringe contains dalteparin sodium 10,000 IU (anti-factor Xa)
in 0.4ml of isotonic solution.
Each pre-filled syringe contains dalteparin sodium 12,500 IU (anti-factor Xa)
in 0.5ml of isotonic solution.
Each pre-filled syringe contains dalteparin sodium 15,000 IU (anti-factor Xa)
in 0.6ml of isotonic solution.

Step 3:
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 4:
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 5:
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 box provided. Keep your sharps
box out of reach of other people. When the sharps box 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
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)
 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
 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

Each pre-filled syringe contains dalteparin sodium 18,000 IU (anti-factor Xa)
in 0.72ml 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 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 single dose syringes
sealed with a rubber stopper. 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. Each pack contains 5 syringes.
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.
PL 10383/1959 Fragmin 10,000 IU/0.4 ml Solution for Injection
PL 10383/1960 Fragmin 12,500 IU/0.5 ml Solution for Injection
PL 10383/1961 Fragmin 15,000 IU/0.6 ml Solution for Injection
PL 10383/1962 Fragmin 18,000 IU/0.72 ml Solution for Injection

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Who makes and repackages your medicine?
Your medicine is manufactured by Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 23.05.2013.

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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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