Fragmin 10,000units/1ml solution for injection ampoules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Dalteparin sodium

Mevcut itibaren:

Pfizer Ltd

ATC kodu:

B01AB04

INN (International Adı):

Dalteparin sodium

Doz:

10000unit/1ml

Farmasötik formu:

Solution for injection

Uygulama yolu:

Subcutaneous; Intravenous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 02080100; GTIN: 5012882008192

Bilgilendirme broşürü

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
FRAGMIN® 10,000 IU/1 ml and 10,000 IU/4 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 2 strengths:
10,000 IU/ 1 ml solution for injection.
10,000 IU/ 4 ml solution for injection.
Abbreviation: IU = International units
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.
You may be given Fragmin for the following conditions:
•
HAEMODIALYSIS/HAEMOFILTRATION:
Fragmin may be used in patients having haemodialysis or
haemofiltration. Fragmin prevents
blood clots being formed in the tubes of the equipment.
Haemodialysis and haemofiltration are methods of removing excessive
natural waste products
from the blood of people whose kidneys are no longer able to perform
this function.
The 10,000 IU/1 ml can also be used to treat conditions such as venous
thromboembolism
and unstable coronary artery disease.
Page 2 of 7
•
VENOUS THROMBOEMBOLISM:
Venous thromboembolism is a condition where blood clots develop in the
legs (deep vein
thrombosis) or the lungs (pulmonary embolism). This can happen
following surgery,
pregnancy or long periods of bed rest.
•
UNSTABLE CORONARY ARTERY DISEASE:
In patie

Ürün özellikleri

OBJECT 1
FRAGMIN 10,000 IU/1 ML
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin 10,000 IU/1 ml
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
Ampoules containing dalteparin sodium, 10,000 IU (anti-Factor Xa) in 1
ml.
3. Pharmaceutical form
Solution for injection for intravenous or subcutaneous administration.
4. Clinical particulars
4.1 Therapeutic indications
Prevention of clotting in the extracorporeal circulation during
haemodialysis or haemofiltration, in
patients with chronic renal insufficiency or acute renal failure.
Treatment of venous thromboembolism (VTE) presenting clinically as
deep vein thrombosis (DVT),
pulmonary embolism (PE) or both.
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
Recommended dosage for adults
(I) PREVENTION OF CLOTTING DURING HAEMODIALYSIS AND HAEMOFILTRATION
In chronic renal insufficiency for patients with no known additional
bleeding risk, the dosage is:
(a) Long-term haemodialysis or haemofiltration - duration of
haemodialysis/haemofiltration more than 4
hours;
An I.V. bolus injection of Fragmin 30-40 IU (anti-Factor Xa)/kg
bodyweight, followed by an infusion of
10-15 IU (anti-Factor Xa)/kg bodyweight/hour.
(b) Short-term haemodialysis or haemofiltration - duration of
haemodialysis/haemofiltration less than 4
hours:
Either as above, or, a single IV. bolus injection of Fragmin 5000 IU
(anti-Factor Xa).
Both for long and short-term haemodialysis and haemofiltration, the
plasma anti-Factor Xa levels should
be with