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FRAGMIN GRADUATED SYRINGE 10 000 IU/ML SOLUTION FOR INJECTION

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Package leaflet: Information for the user

Fragmin

®


Graduated Syringe 10,000 IU/ml Solution for Injection
dalteparin sodium

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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 one
strength:
10,000 IU (International Units)/1 ml
Solution for injection.
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 may be used to treat a
condition known as unstable angina
and non-Q wave myocardial infarction
(unstable coronary artery disease) in
patients who are taking aspirin.
• 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.
Ask your doctor if you are unsure why you
have been given Fragmin.
2. What you need to know before you
are given 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 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.
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 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 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.
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 antiinflammatory 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 tell your doctor or pharmacist if
you are taking or have recently taken any
other low molecular weight heparins or
anti-thrombotics.
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...

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. 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 breastfeeding.
Driving and using machines
Fragmin does not affect the ability to drive
and operate machinery.

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3. How Fragmin is given to you
Your medicine will usually be
administered by a doctor or nurse. The
amount of Fragmin you receive will
depend on your particular condition.
Fragmin is given as a 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.
Use in adults and the elderly
• 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. Doses are
usually given for between 5 and
8 days. The maximum dose in a
12 hour period is 10,000 IU. 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
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 initiate measures to decrease
the risk of bleeding.
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 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,

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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 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 25°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
Graduated Syringes is dalteparin
sodium. Each syringe contains 10,000 IU
(International units) of dalteparin sodium
as a sterile solution for injection.
The other ingredients are water for
injections, sodium chloride and either
sodium hydroxide or hydrochloric acid (to
balance the acidity of the injection).
What Fragmin looks like and contents
of the pack
Fragmin is a clear, colourless or strawcoloured solution in pre-filled single dose
syringes. Each pack contains 5 syringes.
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 in 03/2014
Ref: FR 12_0

100002233-S

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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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