Fragmin 10,000units/4ml solution for injection ampoules

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:

2500unit/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Subcutaneous; Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02080100; GTIN: 5012882008208

Prospect

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

Caracteristicilor produsului

OBJECT 1
FRAGMIN 10,000 IU/4ML
Summary of Product Characteristics Updated 19-May-2016 | Pfizer
Limited
1. Name of the medicinal product
Fragmin 10,000 IU/4ml
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 10,000 IU/4 ml: Ampoules containing dalteparin sodium
corresponding to 2,500 IU (anti-Factor
Xa)/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.
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 iv 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 within the range 0.5-1.0 IU (anti-Factor Xa)/ml.
In acute renal failure, or chronic renal failure in patients with a
high risk of bleeding, the dosage is:
An iv bolus injection of Fragmin 5-10 IU (anti-Factor Xa)/kg
bodyweight, followed by an infusion of 4-5
IU (anti-Factor Xa)/kg bodyweight/hour.
The plasma anti-Factor Xa levels should be within the range 0.