Strensiq

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

asfotase alfa

Saatavilla:

Alexion Europe SAS

ATC-koodi:

A16AB

INN (Kansainvälinen yleisnimi):

asfotase alfa

Terapeuttinen ryhmä:

Other alimentary tract and metabolism products,

Terapeuttinen alue:

Hypophosphatasia

Käyttöaiheet:

Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-08-28

Pakkausseloste

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
STRENSIQ 40 MG/ML SOLUTION FOR INJECTION
(12 MG/0.3 ML 18 MG/0.45 ML 28 MG/0.7 ML 40 MG/1 ML)
asfotase alfa
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Strensiq is and what it is used for
2.
What you need to know before you use Strensiq
3.
How to use Strensiq
4.
Possible side effects
5.
How to store Strensiq
6.
Contents of the pack and other information
1.
WHAT STRENSIQ IS AND WHAT IT IS USED FOR
WHAT IS STRENSIQ
Strensiq is a medicine used to treat the inherited disease
hypophosphatasia that started in childhood. It
contains the active substance asfotase alfa.
WHAT IS HYPOPHOSPHATASIA
Patients with hypophosphatasia have low levels of an enzyme called
alkaline phosphatase that is
important for various body functions, including the proper hardening
of bones and teeth. Patients have
problems with bone growth and strength, which can lead to broken
bones, bone pain, and difficulty
walking, as well as difficulties with breathing and a risk of seizures
(fits).
WHAT IS STRENSIQ USED FOR
The active substance in Strensiq can replace the missing enzyme
(alkaline phosphatase) in
hypophosphatasia. It is used for long-term enzyme replacement
treatment to manage symptoms.
WHAT BENEFITS OF STRENSIQ HAVE

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Strensiq 40 mg/ml solution for injection
Strensiq 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Strensiq 40 mg/ml solution for injection
Each ml of solution contains 40 mg of asfotase alfa*.
Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40
mg/ml).
Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40
mg/ml).
Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40
mg/ml).
Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40
mg/ml).
Strensiq 100 mg/ml solution for injection
Each ml of solution contains 100 mg of asfotase alfa*.
Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100
mg/ml).
* produced by recombinant DNA technology using mammalian Chinese
Hamster Ovary (CHO) cell
culture.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, slightly opalescent or opalescent, colourless to slightly
yellow, aqueous solution; pH 7.4. A few
small translucent or white particles may be present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Strensiq is indicated for long-term enzyme replacement therapy in
patients with paediatric-onset
hypophosphatasia to treat the bone manifestations of the disease (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
management of patients with
metabolic or bone disorders.
3
Posology
Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight
administered
subcutaneously three times per week, or a dosage regimen of 1 mg/kg of
body weight administered
subcutaneously six times per week.
Maximum recommended dose of asfotas