FRAGMIN 10 000 IU/4ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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date:15-APR-14 09:42:27

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Package leaflet: Information for the user

Fragmin®10,000 IU/1 ml and
RECTO

10,000 IU/4 ml Solution for injection
dalteparin sodium

8R3805
207

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.
• 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.
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 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 contains the active ingredient dalteparin sodium. It is
available in 2 strengths:
10,000 IU/1 ml solution for injection.
10,000 IU/4 ml solution for injection.
Abbreviation: IU = International units

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.
You may be given Fragmin for the following conditions:
• Haemodialysis/Haemofiltration:
Fragmin may be used in patients having haemodialysis or
haemofiltration. Fragmin prevents blood clots being formed
in the tubes of the equipment.
Haemodialysis and haemofiltration are methods of removing
excessive natural waste products from the blood of people
whose kidneys are no longer able to perform this function.
The 10,000 IU/1 ml can also be used to treat conditions
such as venous thromboembolism and unstable coronary
artery disease.
• Venous thromboembolism:
Venous thromboembolism is a condition where blood clots
develop in the legs (deep vein thrombosis) or the lungs
(pulmonary embolism). This can happen following surgery,
pregnancy or long periods of bed rest.
• Unstable coronary artery disease:
In patients with 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.
Fragmin helps to prevent more clots being formed.

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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 a stomach ulcer or ulcer of the duodenum (small
intestine).
• if you have suffered from a brain haemorrhage (bleeding in
your brain).
• 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 an injury to, or are about to have an operation
involving your spine, head, eyes or ears.
• if you are suffering from thrombocytopenia (a condition where
there are fewer clotting cells known as platelets in the blood,
causing you to bruise and bleed more easily). Your doctor will
have told you if you have this.

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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.
Your doctor will monitor your blood regularly before and during
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. Fragmin
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)
• Solutions given to increase blood volume (e.g. dextrans)

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

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before you take
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
• 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.

• Etacrynic acid (a water retention tablet (diuretic))

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

8R3805

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

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• 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 ( e.g. 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.
Continued overleaf ...

15-APR-14 GLA

country

ENGLAND

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

VERSO

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
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.
However, if you have an artificial heart valve and are pregnant,
the usual dose of Fragmin might not be enough to prevent a
blood clot. Your doctor will discuss this with you.
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 be administered by a doctor or nurse.
Fragmin is given either as an injection into a vein or as
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.
The amount of Fragmin you receive will depend on your
particular condition.
• Haemodialysis/Haemofiltration
Use in adults and the elderly:
If you are undergoing haemodialysis or haemofiltration, the
medicine will be injected into the tubes of the haemodialysis
machine. For patients with chronic (long term) kidney
problems, who are being given treatment lasting longer than
4 hours, a starting dose of 30-40 IU for each kg of
bodyweight will usually be given. This is followed by an
infusion (slow injection) of 10-15 IU/kg every hour. The same
dose may be given if the treatment lasts less than 4 hours,
or a single injection of 5000 IU may be given.
For patients with acute (rapid or severe) kidney failure, or
patients who are more likely to bleed, the usual dose is
5-10 IU for each kg of body weight, followed by 4-5 IU/kg
every hour.

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 site of injection
• Haematoma – collection 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 (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.

• Deep Vein Thrombosis
Use in adults and the elderly:
If you are having treatment for deep vein thrombosis you will
be given an injection beneath the skin. The site of this
injection will usually be the stomach (abdomen) or outer
aspects of your thigh. A dose of 200 IU for each kg of body
weight may be given once a day, or 100 IU/kg twice a day.
The single daily dose should not exceed 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.
• Unstable Coronary Artery Disease
Use in adults and the elderly:
In the treatment of unstable coronary artery disease, a dose
of 120 IU/kg of body weight is given every 12 hours, as an
injection beneath the skin. 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 in a 12 hour period is 10,000 IU.
• Extended use
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 dose
should be either 5,000 IU (women less than 80 kg and men
less than 70 kg) or 7,500 IU (women 80 kg and above or
men 70 kg and over) every 12 hours. 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.
Medical staff may take blood samples during your treatment
to monitor the effects of Fragmin.
• 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 want to give you an injection of protamine as an
antidote.

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4. Possible side effects

If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

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 this medicine 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.
Store below 30°C.
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. They
contain the following:
4 ml ampoule: 2,500 IU/ml (intl unit)
1 ml ampoule: 10,000 IU (intl unit).
The other ingredients are water for injections and sodium
chloride.
What Fragmin looks like and contents of the pack
Fragmin is a clear colourless or straw coloured solution in a
glass ampoule. Each pack contains 5 ampoules.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ, UK
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium
This leaflet was last revised 03/2014.
Ref: FR 12_0

8R3805

code

8R3805

guidelines

TSE-I012D

dimensions

148x317/35

date

15-APR-14 GLA

country

ENGLAND

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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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