Evenity

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Romosozumab

Διαθέσιμο από:

UCB Pharma S.A.

Φαρμακολογική κατηγορία (ATC):

M05BX

INN (Διεθνής Όνομα):

romosozumab

Θεραπευτική ομάδα:

Drugs for treatment of bone diseases

Θεραπευτική περιοχή:

Osteoporosis

Θεραπευτικές ενδείξεις:

Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Περίληψη προϊόντος:

Revision: 4

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-12-09

Φύλλο οδηγιών χρήσης

Draft
39
B. PACKAGE LEAFLET
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40
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVENITY 105 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
romosozumab
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You will be given a patient alert card, which contains important
safety information you need to
be aware of before and during your treatment with EVENITY.
WHAT IS IN THIS LEAFLET
1.
What EVENITY is and what it is used for
2.
What you need to know before you use EVENITY
3.
How to use EVENITY
4.
Possible side effects
5.
How to store EVENITY
6.
Contents of the pack and other information
1.
WHAT EVENITY IS AND WHAT IT IS USED FOR
WHAT EVENITY IS
EVENITY contains the active substance romosozumab, a medicine that
helps to make the bones
stronger, and reduce the risk of broken bones.
WHAT EVENITY IS USED FOR
EVENITY is used to treat severe osteoporosis in women after the
menopause who are at high risk of
broken bone (fracture).
Osteoporosis is a disease that causes your bones to become thin and
fragile. Many patients with
osteoporosis have no symptoms, but they may be at increased risk of
fractures.
HOW EVENITY WORKS
EVENITY is a monoclonal antibody. A monoclonal antibody is a type of
protein that has been
designed to recognize and attach to specific proteins in the body.
EVENITY attaches to a protein
called sclerosti

Αρχείο Π.Χ.Π.

Draft
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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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
EVENITY 105 mg solution for injection in pre-filled pen
EVENITY 105 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EVENITY 105 mg solution for injection in pre-filled pen
Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of
solution (90 mg/ml).
EVENITY 105 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 105 mg of romosozumab in 1.17 ml of
solution (90 mg/ml).
Romosozumab is a humanized IgG2 monoclonal antibody produced using
recombinant DNA
technology in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Solution for injection (injection)
Clear to opalescent, colorless to light yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EVENITY is indicated in treatment of severe osteoporosis in
postmenopausal women at high risk of
fracture (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialist physicians
experienced in the management
of osteoporosis.
Posology
The recommended dose is 210 mg romosozumab (administered as two
subcutaneous injections of
105 mg each) once monthly for 12 months.
Patients should be adequately supplemented with calcium and vitamin D
before and during treatment
(see sections 4.3 and 4.4).
Patients treated with EVENITY should be given the package leaflet and
the patient alert card.
Draft
3
Following completion of romosozumab therapy, transition to
antiresorptive therapy is recommended
in order to extend the benefit achieved with romosozumab beyond 12
months.
_Missed doses _
If the romosozumab dose is missed, administer as soon a