Elaprase 6mg3ml concentrate for solution for infusion vials

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Idursulfase

Dostępny od:

Shire Pharmaceuticals Ltd

Kod ATC:

A16AB16

INN (International Nazwa):

Idursulfase

Dawkowanie:

2mg/1ml

Forma farmaceutyczna:

Solution for infusion

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 09081000; GTIN: 7350006499210

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELAPRASE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
idursulfase
▼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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. 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 any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Elaprase is and what it is used for
2.
What you need to know before you use Elaprase
3.
How to use Elaprase
4.
Possible side effects
5
How to store Elaprase
6.
Contents of the pack and other information
1.
WHAT ELAPRASE IS AND WHAT IT IS USED FOR
Elaprase is used as enzyme replacement therapy to treat children and
adults with Hunter syndrome
(Mucopolysaccharidosis II) when the level of the enzyme
iduronate-2-sulfatase in the body is lower than
normal, helping improve the symptoms of the disease. If you suffer
from Hunter syndrome, a
carbohydrate called glycosaminoglycan which is normally broken down by
your body, is not broken
down and slowly accumulates in various organs in your body. This
causes cells to function abnormally,
thereby causing problems for various organs in your body which can
lead to tissue destruction and organ
malfunction and failure. Typical organs where glycosaminoglycan
accumulates are spleen, liver, lungs,
heart, and connective tissue. In some patients glycosaminoglycan
accumulates also in the brain. Elaprase
contains an active substance called idursulfase which works by acting
as a replacemen

Charakterystyka produktu

OBJECT 1
ELAPRASE 2 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 15-Sep-2016 | Shire
Pharmaceuticals Limited
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
Elaprase 2 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of
idursulfase*.
Excipient with known effect
Each vial contains 0.482 mmol of sodium.
For the full list of excipients, see section 6.1.
* idursulfase is produced by recombinant DNA technology in a
continuous human cell line.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
A clear to slightly opalescent, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Elaprase is indicated for the long-term treatment of patients with
Hunter syndrome
(Mucopolysaccharidosis II, MPS II).
Heterozygous females were not studied in the clinical trials.
4.2 Posology and method of administration
This treatment should be supervised by a physician or other healthcare
professional experienced in the
management of patients with MPS II disease or other inherited
metabolic disorders.
Posology
Elaprase is administered at a dose of 0.5 mg/kg body weight every week
by intravenous infusion over a 3
hour period, which may be gradually reduced to 1 hour if no
infusion-associated reactions are observed
(see section 4.4).
For instruction for use, see section 6.6.
Infusion at home may be considered for patients who have received
several months of treatment in the
clinic and who are tolerating their infusions well. Home infusions
should be performed under the
surveillance of a physician or other healthcare professional.
Special populations
_Elderly patients_
There is no clinical experience in patients over