Fragmin Graduated Syringe 10,000units/1ml solution for injection pre-filled syringes

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Dalteparin sodium

Tilgjengelig fra:

Pfizer Ltd

ATC-kode:

B01AB04

INN (International Name):

Dalteparin sodium

Dosering :

10000unit/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Subcutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02080100; GTIN: 5012882008185

Informasjon til brukeren

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fragmin
®
Graduated Syringe 10,000 IU/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.
• 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 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 contains the active ingredient dalteparin sodium. It is
available in one strength:
10,000 IU (International Units)/1 ml Solution for injection.
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 may be used to treat a condition known as unstable angina
and non-Q wave
myocardial infarction (unstable coronary artery disease) in patients
who are taking aspirin.
• 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FRAGMIN
YOU SHOULD NOT BE GIVEN FRAGMIN:
• if you are allergic (hypersensitive) to the active ingredient
dalteparin sodium or a
similar product or any of

Preparatomtale

OBJECT 1
FRAGMIN GRADUATED SYRINGE 10,000 IU/ML
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin
®
Graduated Syringe 10,000 IU/ml Solution for Injection
2. Qualitative and quantitative composition
Pre-filled, single dose syringes containing dalteparin sodium 10,000
IU (anti-Factor Xa) in 1.0 ml
solution for injection.
Fragmin Graduated Syringes do 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
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
ADULTS
120 IU/kg body weight are administered subcutaneously 12 hourly for up
to 8 days if considered of
benefit by the physician. Maximum dose is 10,000 IU/12 hours.
Patients needing treatment beyond 8 days, while awaiting
angiography/revascularisation, should receive a
fixed dose of either 5,000 IU (women < 80 kg and men <70 kg) or 7,500
IU (women ≥80 kg and men ≥70
kg) 12 hourly. Treatment is recommended to be given until the day of
the revascularisation procedure
(PTCA or CABG) but not for more than 45 days.
PAEDIATRIC POPULATION
The safety and efficacy of dalteparin sodium in children has not been
established. Currently available data
are described in sections 5.1 and 5.2 but no recommendation on a
posology can be made.
MONITORING ANTI-XA LEVELS IN CHILDREN
Measurement of peak anti-Xa levels at about 4 hours post-dose should
be considered for certain special
populations receiving Fragmin, such as children. For therapeutic
treatment with doses administered once
daily, peak anti-Xa levels should generally be maintained betwe