Pill Identifier App

FRAGMIN 18000 IU/0.72 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Page 1

Page 4

Manufacturer and Product Licence
Holder
This product is manufactured by Pfizer
Manufacturing Belgium NV, Rijksweg 12,
2870 Puurs, Belgium. It is procured from
within the EU by the Product Licence
Holder: Swinghope Ltd, Brandon House,
Marlowe Way, Croydon CR0 4XS and
repackaged by Interport Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS.

T05029

Fragmin® 10,000 IU/0.4 ml Solution for Injection
and
Fragmin® 18,000 IU/0.72 ml Solution for Injection
(dalteparin sodium)

Patient Information Leaflet
This medicine is available under either of the
above strengths but will be referred to as
Fragmin throughout the following:
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.

POM
PL No: 10380/1497
Fragmin® 18,000 IU/0.72 ml Solution for
Injection
PL No: 10380/1498
Fragmin® 10,000 IU/0.4 ml Solution for
Injection
Leaflet revision date: 27/10/2014
Fragmin® is a registered trademark of
Pfizer Health AB, 112 87, Stockholm,
Sweden.

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 to know 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.

Fold

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.
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).
called
non-steroidal
• Medicines
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.
C
(e.g.
some
vitamin
• Vitamin
supplements).

Page 3

Page 2

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.

Abbreviations: IU = International Unit

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

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.

Dose of Fragmin during months 2-6

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.

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.
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 outer aspects of your
thigh. It should not be injected into your
muscles.
Use in adults and the elderly
To
treat
blood
clots
thromboembolism)

(venous

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
46-56
57-68
69-82
≥ 83

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

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

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.

This treatment course is not recommended
for patients weighing less than 40 kg.

In some cases of decreased platelet count
(clotting cells), your doctor may interrupt
your treatment with Fragmin for a short
period.

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.

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.

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.

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.

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.

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.

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.
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.

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)

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

− 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 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.

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).

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.

− 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

− 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 out of the sight and reach of
children.
• Do not store above 25°C.
• Fragmin should not be used after the
expiry date mentioned on the pack.
The expiry date refers to the last day of
that month.
• 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 syringe provides a single dose of
dalteparin sodium
10,000 IU/0.4 ml Solution for injection.
18,000 IU/0.72 ml Solution for injection.
• The other ingredients are Water for
Injections and either Sodium Hydroxide
or Hydrochloric Acid for pH adjustment.
What Fragmin looks like and contents
of the pack
• Fragmin Solution for Injection is a clear,
colourless or straw coloured solution
and is supplied in pre-filled single dose
syringes sealed with a grey rubber
stopper.
• Each pack contains 5 pre-filled
syringes.

T05029
Fold

To
treat
blood
clots
(venous
thromboembolism) in certain types of
cancer and prevent recurrence

− 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

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
(web1)