FRAGMIN 100 000 IU/4ML MULTIDOSE VIAL SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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date:18-APR-14 10:39:52

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Package leaflet: Information for the user

RECTO

100,000 IU/4 ml Multidose Vial
dalteparin sodium

8R3804
212

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: 100,000 IU (International
Units)/4 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 is used to treat blood clots (venous
thromboembolism).
• Venous thromboembolism is a condition where blood
clots develop in the legs (deep vein thrombosis) or the
lungs (pulmonary embolism), e.g. after surgery or
prolonged bed-rest.
Ask your doctor if you are unsure why you have been
given Fragmin.

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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 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

code

8R3804

guidelines

TSE-I012D

dimensions

148x317/35

date

• 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.
If you are pregnant your doctor will decide if this medicine
is suitable for you. Fragmin 100,000 IU/4 ml Multidose Vials
contain the preservative benzyl alcohol. Benzyl alcohol may
cross the placenta and cause harmful effects to the baby.

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 (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 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.

15-APR-14 GLA

country

ENGLAND

VERSO

Pregnancy and breast-feeding
Tell your doctor if you are pregnant (see section ’Fragmin
contains benzyl alcohol’).
Fragmin has not been found to cause harmful effects
during pregnancy. The possibility of harm to the baby
appears remote. 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 breast-feeding.
Fragmin contains benzyl alcohol
Fragmin 100,000 IU/4 ml Multidose Vials are not
recommended for use during pregnancy. This is because
multidose vials contain a preservative, benzyl alcohol,
which may cross the placenta and cause harmful effects to
the baby.
Fragmin 100,000 IU/4 ml Multidose Vials must not be
given to premature babies or neonates as they contain
benzyl alcohol. They may cause toxic reactions and allergic
reactions in infants and children up to 3 years old.
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. The amount of Fragmin you receive will depend on
your particular condition and the amount of Fragmin you
receive will depend on your body weight.
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. It should not be injected into your
muscles.

Use in adults and the elderly
The recommended dose is 200 IU for each kg of body
weight and may be given once a day (with a maximum
daily dose of 18,000 IU), or 100 IU/kg twice a day. Your
doctor will work out the right dose for you. 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. Fragmin can be used together with other blood
thinning medicines known as Vitamin K antagonist. 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.
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)

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- 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.

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.
The vial may be used to give a number of doses, but once
the vial has been opened the solution should be used
within 14 days.
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.
Each vial contains a total of 100,000 IU (International units)
of dalteparin sodium in 4 ml of solution, that is 25,000 IU in
each ml of solution.
The other ingredients are water for injections and benzyl
alcohol.
Fragmin 100,000 IU/4 ml vials contain benzyl alcohol as a
preservative. These multi-dose vials must not be used in
premature or newborn babies. Benzyl alcohol may cause
toxic reactions and allergic reactions in infants and children
up to 3 years old.
Other formulations without benzyl alcohol are available.
What Fragmin looks like and contents of the pack
Fragmin 100,000 IU/4 ml multidose vial is a clear,
colourless or straw coloured solution. Each pack contains
1 vial.
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

8R3804

code

8R3804

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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