Defitelio 200mg2.5ml concentrate for solution for infusion vials

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Defibrotide

Beschikbaar vanaf:

Jazz Pharmaceuticals UK

INN (Algemene Internationale Benaming):

Defibrotide

Dosering:

80mg/1ml

farmaceutische vorm:

Solution for infusion

Toedieningsweg:

Intravenous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF:

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFITELIO 80 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Defibrotide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
−
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Defitelio is and what it is used for
2.
What you need to know before you are administered Defitelio
3.
How you will be given Defitelio.
4.
Possible side effects.
5.
How to store Defitelio.
6.
Contents of the pack and other information.
1.
WHAT DEFITELIO IS AND WHAT IT IS USED FOR
Defitelio is a medicine that contains the active substance
defibrotide.
It is used to treat a condition called hepatic veno-occlusive disease,
in which the blood vessels in the
liver become damaged and obstructed by blood clots. This can be caused
by medicines that are given
prior to a stem cell transplantation.
Defibrotide works by protecting the cells of the blood vessels and
preventing or breaking down the
blood clots.
This medicine can be used in adults, and in adolescents, children and
infants over one month of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEFITELIO
DO NOT USE DEFITELIO
•
if you are allergic to defibrotide or other ingredients of this
medicine (listed in section 6)
•
if you are using other medicines to break down blood clots such as
tissue plasminogen activator
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Defitelio:
•
if you have heavy bleeding and need a blood transfusion
•
if you are undergoing surgery
•
if you have problems with blood circulation because your bod

Productkenmerken

OBJECT 1
DEFITELIO 80 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 31-May-2016 | Gentium SPA a
Jazz Pharmaceuticals
company
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Defitelio 80 mg/mL concentrate for solution for infusion
2. Qualitative and quantitative composition
One mL contains defibrotide* 80mg corresponding to a quantity of 200
mg in 2.5 mL in a vial and
corresponding to a concentration in the range of 4 mg/mL to 20 mg/mL
after dilution
* produced from porcine intestinal mucosa.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
The solution is clear light yellow to brown, free from particulate
matter or turbidity.
4. Clinical particulars
4.1 Therapeutic indications
Defitelio is indicated for the treatment of severe hepatic
veno-occlusive disease (VOD) also known as
sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell
transplantation (HSCT) therapy.
It is indicated in adults and in adolescents, children and infants
over 1 month of age .
4.2 Posology and method of administration
Defitelio must be prescribed and administered to patients by
specialised physicians experienced in the
diagnosis and treatment of complications of HSCT.
Posology
The recommended dose is 6.25 mg/kg body weight every 6 hours (25
mg/kg/day).
There is limited efficacy and safety data on doses above this level
and consequently it is not
recommended to increase the dose above 25 mg/kg/day.
Defitelio should be administered for a minimum of 21 days and
continued until the symptoms and signs
of severe VOD resolve.
_Renal Impairment_
Dose adjustment is not required for patients with renal impairment or
who are on intermittent
haemodialysis (see section 5.2).
_Hepatic