STRENSIQ 40 MGML

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

ASFOTASE ALFA

Saadav alates:

ALEXION PHARMA ISRAEL LTD

ATC kood:

A16AB13

Ravimvorm:

SOLUTION FOR INJECTION

Koostis:

ASFOTASE ALFA 40 MG / 1 ML

Manustamisviis:

S.C

Retsepti tüüp:

Required

Valmistatud:

ALEXION PHARMA GMBH, SWITZERLAND

Terapeutiline ala:

ASFOTASE ALFA

Näidustused:

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

Loa andmise kuupäev:

2021-01-31

Infovoldik

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
’
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon
a physician's prescription only
STRENSIQ
® 40 MG/ML
SOLUTION FOR SUBCUTANEOUS INJECTION
STRENSIQ
® 100 MG/ML
SOLUTION FOR SUBCUTANEOUS INJECTION
THE ACTIVE INGREDIENT AND ITS
CONCENTRATION:
Each 1 ml contains:
asfotase alfa 40 mg
THE ACTIVE INGREDIENT AND ITS
CONCENTRATION:
Each 1 ml contains:
asfotase alfa 100 mg
For the list of excipients, please see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions, refer to your physician
or pharmacist.
This medicine has been prescribed for your illness. Do not pass it on
to others. It may harm them,
even if you think that their illness is similar to yours.
In addition to the leaflet, there is a patient safety information card
for Strensiq. This card contains
important safety information that you need to know, before commencing
treatment and during
the course of the treatment with Strensiq and adhere to. Read the
patient safety information
card and this patient leaflet before commencing use of this medicine.
Keep the card for further
review, if necessary
1. WHAT IS THE MEDICINE USED FOR?
Strensiq is a medicine used to treat the inherited disease
hypophosphatasia that started in
childhood.
Strensiq is indicated for long-term enzyme replacement therapy in
patients with paediatric-onset
hypophosphatasia to treat the bone manifestations of the disease.
THERAPEUTIC GROUP:
Other alimentary tract and metabolism products, Enzymes.
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).
The active substance in S

Toote omadused

1
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.
Patient safety information card
The marketing of Strensiq is subject to a risk management plan (RMP)
including a ‘Patient safety
information card’. The ‘Patient safety information card’,
emphasizes important safety information
that the patient should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
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.
2
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
bo