Fragmin 18,000units/0.72ml 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: 5012882008178

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
FRAGMIN®
10,000 IU/0.4 ml, 12,500 IU/0.5 ml, 15,000 IU/0.6 ml & 18,000 IU/0.72
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 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.
Ask your doctor if you are unsure why you have been given Fragmin.
Page 1 of 9
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 this medicine (listed in
section 6).
• if you have an active stomach ulcer

Caracteristicilor produsului

OBJECT 1
FRAGMIN 18,000 IU/0.72ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin
®
18,000 IU/0.72ml solution for injection
2. Qualitative and quantitative composition
Fragmin 18,000 IU: single dose syringe containing dalteparin sodium
18,000 IU (anti-Factor Xa) in 0.72
ml solution for injection equivalent to 25,000 IU/ml.
For excipients see section 6.1
Fragmin does not contain preservatives.
*Potency is described in International anti-Factor Xa units (IU) of
the 1st 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.
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)
46-56
10,000 IU
57-68
12,500 IU
69-82
15,000 IU
83 AND OVER
18,000 IU
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.
For patients with an increased risk of bleeding, it is recommended
that Fragmin be administered
according to the twice daily regimen detailed in the Summary of
Product Characteristics for Fragmin
10,000 IU/1ml ampoules or Fragmin Multidose Vial.
PAEDIATRIC POPULATION
The safety and efficacy of d