Fragmin 7,500units/0.3ml solution for injection pre-filled syringes

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Dalteparin sodium

Disponibil de la:

Pfizer Ltd

Codul ATC:

B01AB04

INN (nume internaţional):

Dalteparin sodium

Dozare:

25000unit/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Subcutaneous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02080100; GTIN: 5012882008130

Prospect

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
FRAGMIN® STERILE SOLUTION FOR INJECTION 7,500 IU/0.3 ML
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 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.
• 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

Caracteristicilor produsului

OBJECT 1
FRAGMIN 7,500 IU/0.3 ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin
®
7,500 IU/0.3 ml solution for injection
2. Qualitative and quantitative composition
Fragmin 7,500 IU: single dose syringe containing dalteparin sodium
7,500 IU (anti-Factor Xa*) in 0.3 ml
solution for injection equivalent to 25,000 IU/ml.
For excipients, see 6.1
Fragmin does not contain preservatives.
*Potency is described in International anti-Factor Xa units (IU) of
the 1
st
International Standard for Low
Molecular Weight Heparin.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of venous thromboembolism (VTE) presenting clinically as
deep vein thrombosis (DVT),
pulmonary embolism (PE) or both.
Patients with solid tumours: Extended treatment of symptomatic venous
thromboembolism (VTE) and
prevention of its recurrence.
Unstable angina and non-Q wave myocardial infarction (unstable
coronary artery disease-UCAD),
administered concurrently with aspirin.
Extended Use
Fragmin may be used beyond 8 days in patients awaiting angiography/
revascularisation procedures (see
Section 5.1)
4.2 Posology and method of administration
TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) PRESENTING CLINICALLY AS
DEEP VEIN THROMBOSIS (DVT),
PULMONARY EMBOLISM (PE) OR BOTH:
ADULTS
A single dose of Fragmin is administered subcutaneously, once daily
according to the following weight
ranges. Monitoring of the anticoagulant effect is not usually
necessary.
WEIGHT (KG)
DOSE (IU)
< 46
7,500
46-56
10,000
57-68
12,500
69-82
15,000
83 and over
18,000
Abbreviations: IU = International Unit
The single daily dose should not exceed 18,000 IU.
Simultaneous anti-coagulation with vitamin K antagonists can be
started immediately. Treatment with
Fragmin is continued until the prothrombin complex levels (Factor II,
VII, IX and X) have decreased to a
therapeutic level. At least five days of combined treatment is
normally required.
PATIE