Fragmin 5,000units/0.2ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dalteparin sodium

Available from:

Pfizer Ltd

ATC code:

B01AB04

INN (International Name):

Dalteparin sodium

Dosage:

25000unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100; GTIN: 5012882008123

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
FRAGMIN® 2,500 IU/0.2 ML & 5,000 IU/0.2 ML SOLUTION FOR INJECTION
dalteparin sodium
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 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 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.
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 used to prevent blood clots (venous thromboembolism)
forming before and after an
operation or if you are bedridden due to illness and to prevent their
recurrence.
The 5000 IU product can also be used for:
• Prevention of deep vein thrombosis in patients bedridden due to a
medical condition but not limited
to, for example heart failure and respiratory failure.
• Treatment of patients with solid tumours who suffer from low
platelet counts.
Ask your doctor if you are unsure why you have been given Fra

Summary of Product characteristics

OBJECT 1
FRAGMIN 5000 IU
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin
®
5000 IU
2. Qualitative and quantitative composition
Active ingredient
Dalteparin sodium (INN)
Quality according to Ph.Eur. and in-house specification.
Potency is described in International anti-Factor Xa units (IU) of the
1st International Standard for Low
Molecular Weight Heparin.
Content of active ingredient
Fragmin 5000 IU: single dose syringe containing dalteparin sodium 5000
IU (anti-Factor Xa) in 0.2 ml
solution.
Fragmin syringes do not contain preservatives.
3. Pharmaceutical form
Solution for injection for subcutaneous administration.
4. Clinical particulars
4.1 Therapeutic indications
Peri- and post-operative surgical thromboprophylaxis.
The prophylaxis of proximal deep venous thrombosis in patients
bedridden due to a medical condition,
including, but not limited to; congestive cardiac failure (NYHA class
III or IV), acute respiratory failure
or acute infection, who also have a predisposing risk factor for
venous thromboembolism such as age over
75 years, obesity, cancer or previous history of VTE.
Patients with solid tumours: Extended treatment of symptomatic venous
thromboembolism (VTE) and
prevention of its recurrence.
4.2 Posology and method of administration
PERI- AND POST-OPERATIVE SURGICAL THROMBOPROPHYLAXIS:
ADULTS
Surgical thromboprophylaxis in patients at high risk of thrombosis:
2,500 IU is administered
subcutaneously 1-2 hours before the surgical procedure and 2,500 IU
subcutaneously 8-12 hours later. On
the following days, 5,000 IU subcutaneously each morning.
As an alternative, 5,000 IU is administered subcutaneously the evening
before the surgical procedure and
5,000 IU subcutaneously the following evenings.
Treatment is continued until the patient is mobilised, in general 5-7
days or longer.
Prolonged thromboprophylaxis in hip replacement surgery: 5,000IU is
given subcutaneously the evening
before the operation and 5,000IU subcutaneously the followin