FRAGMIN 12 500 IU/0.5ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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CUSTOMER: Waymade

REF:

PRODUCT:

Fragmin 12,500 15,000 18,000 injection

ARTWORKER:

CODE:

6464/2698 2699 2700 E

DATE OF PROOF: 09/05/13

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.2 - waymade - 09/05/13

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

Pg 1

Pg 4

Fragmin® 12,500 IU/0.5ml Solution for Injection,
Fragmin® 15,000 IU/0.6ml Solution for Injection,
Fragmin® 18,000 IU/0.72ml Solution for Injection

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)
- Common side effects which may affect more than 1 person in 100 are listed below:

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 which may affect more than 1 person in 1,000 are listed below:

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 which may affect more than 1 person in 10,000 are listed below:

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
-The following additional side effects have been reported but it is not known how often they happen:

Bleeding inside or around your brain

Bleeding behind your abdomen (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.

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 stamped on the pack. The expiry date refers to the
last day of that month.
Do not store above 25°C
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 in an isotonic solution.
Three strengths of Fragmin syringes are available.
Each pre-filled syringe provides a single dose of dalteparin sodium
12,500 IU/0.5ml Solution for injection.
15,000 IU/0.6ml Solution for injection.
18,000 IU/0.72ml Solution for injection.
The other ingredients are Water for Injections, and Sodium Hydroxide or Hydrochloric Acid (for pH
adjustment).
What Fragmin looks like and contents of the pack
Fragmin 12,500 IU/0.5 ml Solution for Injection is a clear, colourless or straw-coloured solution and is supplied
in pre-filled single dose syringes with brown-coloured syringe labels, sealed with a rubber stopper.
Fragmin 15,000 IU/0.6 ml Solution for Injection is a clear, colourless or straw-coloured solution and is supplied
in pre-filled single dose syringes with purple-coloured syringe labels, sealed with a rubber stopper.
Fragmin 18,000 IU/0.72 ml Solution for Injection is a clear, colourless or straw-coloured solution and is
supplied in pre-filled single dose syringes with gray-coloured syringe labels, sealed with a rubber stopper.
Each pack contains 5 syringes.
POM

PL No: 6464/2698 Fragmin 12,500 IU/0.5ml
PL No: 6464/2699 Fragmin 15,000 IU/0.6ml
PL No: 6464/2700 Fragmin 18,000 IU/0.72ml

These products are manufactured by Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs, Belgium
and procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 9.5.2013

(dalteparin sodium)
Patient Information Leaflet

This product is available in three different strengths, 12,500 IU/0.5 ml, 15,000 IU/0.6 ml and 18,000 IU/0.72 ml
Solution for Injection 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 or pharmacist.

This medicine has been prescribed for you. 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, nurse or pharmacist. This includes possible side
effects not listed in this leaflet.
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 Fragmin.

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
Tell your doctor 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

Fragmin is a registered trademark of Pfizer Health AB
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

Q.A.
APPROVED:

REF:

PRODUCT:

Fragmin 12,500 15,000 18,000 injection

ARTWORKER:

CODE:

6464/2698 2699 2700 E

DATE OF PROOF: 09/05/13

DT

DATE:

PROOF HISTORY:
v.2 - waymade - 09/05/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

Pg 3

Pg 2

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.

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

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).

≥ 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.
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.

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

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.

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
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 valves during pregnancy.




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

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 upper part of your thigh. It should not be
injected into your muscles.
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

Dose (IU)
7,500

46 - 56

12,500

69 - 82

15,000

≥ 83

Step 3:
Pick up the syringe and 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.
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.

10,000

57 - 68

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.

18,000

Abbreviations: IU = International Unit
Your treatment will last for at least 5 days.
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.
Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.
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).

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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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