FRAGMIN 10000 IU/0.4 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

2406
14.07.14[8]

Fragmin® 10,000 IU/0.4 ml
Solution for Injection
(dalteparin sodium)
Your medicine is available using the above name but will be referred to as
Fragmin throughout the following 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, 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.
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.


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 TOKNOW BEFORE YOU ARE GIVEN OR USE
FRAGMIN
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 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
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 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 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.

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)
< 46
46 to 56
57 to 68
69 to 82
>83

Dose (IU)
7,500
10,000
12,500
15,000
18,000

Abbreviations: IU = International Unit
Your treatment will last for at least 5 days.
The maximum daily dose is 18,000 IU.

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.

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.

Some medicines can affect the way Fragmin works, or Fragmin itself can
reduce the effectiveness of other medicines taken at the same time.

Medical staff may take blood samples during your treatment to monitor
the effects of Fragmin.

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).

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).

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 weight heparins or anti-thrombotics.

Dose of Fragmin during months 2-6
Body Weight (kg)
<56
57 to 68
69 to 82
83 to 98
>99

Dose (IU)
7,500
10,000
12,500
15,000
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.

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 being given or using this
medicine whilst breast-feeding.

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) 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.

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

Please note that if a carer is doing the injecting, it is recommended that
they wear gloves to perform the injection.

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.

Step 1:
Get yourself in a comfortable sitting down position where you can see
your stomach.

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.

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

 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

Step 3:
Pick up the syringe. 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.

 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

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.

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.

Step 5:
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

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.

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 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.
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 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, 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)

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.

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 on the pack.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
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 OTHER INFORMATION
What Fragmin contains
The active ingredient in Fragmin is dalteparin sodium.
Each single dose pre-filled syringe contains dalteparin sodium 10,000 IU
(anti-factor Xa) in 0.4 ml isotonic solution.
Excipients: water for injection and sodium hydroxide or hydrochloric acid
(for pH adjustments).
What Fragmin looks like and contents of the pack
Fragmin is available as a clear, colourless or straw-coloured solution in
pre-filled single dose syringes with a rubber stopper.
Each pack contains 5 x 0.4 ml single dose pre-filled syringes.
Manufacturer and Product Licence holder
Manufactured by Pfizer Manufacturing Belgium NV., Rijksweg 12, 2870
Puurs, Belgium. Procured from the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

Fragmin® 10,000 IU/0.4 ml Solution for Injection
PL 20636/2406

Leaflet issue and Revision date (Ref): 14.07.14[8]
 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

Fragmin is trademark of Pfizer Health AB

Expand view ⇕

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.

Hide
(web3)