FRAGMIN 7 500 IU/0.3ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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Package leaflet: Information for the user

Fragmin

®

dalteparin sodium



Sterile Solution for Injection
7,500 IU/0.3 ml

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.
•  you have any further questions, ask your doctor,
If
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.
•  you get any side effects talk to your doctor,
If
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.  hat Fragmin is and what it is used for
W
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.
• 
Fragmin is also used to treat a condition known as
unstable coronary artery disease. 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.  hat you need to know before you are
W
given or use Fragmin
You should not be given or use Fragmin

•  you are allergic (hypersensitive) to the active
if
ingredient dalteparin sodium or a similar product or
any of the other ingredients of this medicine (listed in
section 6).
•  you have an active stomach ulcer or ulcer of the
if
duodenum (small intestine).
•  you have suffered from a brain haemorrhage (bleeding
if
in your brain).
•  you have fluid mixed with blood that appears around
if
heart and lungs.
•  you suffer from any condition which may cause you to
if
bleed more easily (e.g. haemophilia, liver failure). Ask
your doctor if you are unsure.
•  you have a condition called septic endocarditis (an
if
infection and inflammation of the lining of the heart and
heart valves). Your doctor will have told you if you have
this.
•  you have had a condition called “heparin-induced
if
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.
•  you have an injury to, or have had an operation
if
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:
•  you have conditions which make you more susceptible
if
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.
•  you have been told by your doctor that you have a
if
lot of potassium in your blood or have a low blood pH.
Your doctor will monitor your blood regularly before and
during treatment.
•  you have ever had an operation to insert artificial
if
heart valves.
• 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).
• 
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 (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.

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.
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 (venous thromboembolism)
• Deep Vein Thrombosis
The usual dose of Fragmin used to treat deep vein
thrombosis is 200 IU (units) for every kilogram you weigh,
given once a day. Your doctor will select the dose which is
appropriate for you based on your bodyweight.
The following table shows the dose you will receive
depending on your body weight:
Body weight (kg)

Dose (IU)

< 46

7,500

46-56

10,000

57-68

12,500

69-82

15,000

≥ 83

18,000

Abbreviations: IU = International Unit
The maximum daily dose is 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.
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).
Dose of Fragmin during months 2-6
Body Weight (kg)

Dose (IU)

≤ 56

7,500

57 to 68

10,000

69 to 82

12,500

83 to 98

15,000

≥ 99

18,000

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.
• 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.
The maximum dose in a 12 hour period is 10,000 IU (units).
Doses are usually given for between 5 and 8 days.
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 Adults and the Elderly
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
typical dose for adults, including elderly patients should be
either 5,000 IU (units) (women less than 80 kg and men
less than 70 kg) or 7,500 IU (women 80 kg and above and
men 70 kg and over) every 12 hours.
The maximum dose in a 12 hour period is 10,000 IU.
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.
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.
Please note that if a carer is doing the injecting, it is
recommended that they wear gloves to perform the
injection.

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5. How to store Fragmin

Step 1:

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

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.

Step 2:

Your doctor or nurse will store Fragmin in a safe place
under the above conditions.

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.

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.  ontents of the pack and other
C
information

Step 3:

Pick up the syringe, grasp the tip of the plastic needle
catcher and bend it away from the shield.
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.

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.

What Fragmin contains.

The active ingredient in Fragmin is dalteparin sodium.
Each pre-filled syringe provides a single dose of 7,500 IU
(International units) of dalteparin sodium.
The other ingredients are water for injections, either
sodium hydroxide or hydrochloric acid (to balance the
acidity of the injection).

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, each containing
0.3 ml of dalteparin sodium solution. Each box contains
10 disposable syringes.

Marketing Authorisation Holder

Step 5:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ, UK

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.

Manufacturers

Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium

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.

Catalent France Limoges S.A.S
Z.I. Nord
87 rue de Dion Bouton
87000 Limoges
France
This leaflet was last revised in 03/2014
Ref: FR 14_0

Step 7:

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K

!

Place the plastic
catcher against a
hard stable surface
and with one hand
pivot the syringe
barrel upwards
against the needle
forcing the needle into the catcher where it locks in place.
Continue bending the needle until the syringe exceeds
a 45 degree angle with the flat surface to render it
permanently unusable.
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, 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):
•  reversible decrease in the number of clotting cells
A
(platelets) in your blood (Type I thrombocytopenia).
This may make you bruise more easily.
•  leeding at any site
B
•  ertain substances produced by your liver may
C
increase
• ain and reactions at the site of injection
P
•  aematoma – collection of blood under the skin
H
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):
•  immune system problem resulting in a severe
An
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.

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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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