Eladynos

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

abaloparatide

Disponible depuis:

Theramex Ireland Limited

Code ATC:

H05AA04

DCI (Dénomination commune internationale):

abaloparatide

Groupe thérapeutique:

Calcium homeostasis

Domaine thérapeutique:

Osteoporosis, Postmenopausal; Osteoporosis

indications thérapeutiques:

Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Descriptif du produit:

Revision: 2

Statut de autorisation:

Authorised

Date de l'autorisation:

2022-12-12

Notice patient

24
B.
PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELADYNOS 80 MICROGRAMS/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN
abaloparatide
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.
WHAT IS IN THIS LEAFLET
1.
What Eladynos is and what it is used for
2.
What you need to know before you use Eladynos
3.
How to use Eladynos
4.
Possible side effects
5.
How to store Eladynos
6.
Contents of the pack and other information
1.
WHAT ELADYNOS IS AND WHAT IT IS USED FOR
E
ladynos contains the active substance abaloparatide. It is used to
treat osteoporosis in women after
menopause.
Osteoporosis is especially common in women after menopause. The
disease causes bones to become thin
and fragile. If you have osteoporosis, you are more likely to break
bones, especially in your spine, hips
and wrists.
This medicine is used to make bone stronger and less likely to break.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELADYNOS
DO NOT USE ELADYNOS IF YOU
•
are allergic to abaloparatide or any of the other ingredients of this
medicine (listed in section 6)
•
are pregnant or breast-feeding
•
are still able to get pregnant
•
have high blood calcium levels
•
have severely reduced kidney function
•
have unexplained high blood levels of the enzyme alkaline phosphatase
•
have had radiation therapy involving yo

Résumé des caractéristiques du produit

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
Eladynos 80 micrograms/dose solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (40 microliters) contains 80 micrograms of abaloparatide.
Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of
solution (corresponding to 2 milligrams
per mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Colourless, clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fracture (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 80 micrograms once daily.
The maximum total duration of treatment with abaloparatide should be
18 months (see sections 4.4 and
5.1).
Patients should receive supplemental calcium and vitamin D if dietary
intake is inadequate.
Following cessation of abaloparatide therapy, patients may be
continued on other osteoporosis therapies
such as bisphosphonates.
_Missed dose _
If a patient forgets or cannot administer their dose at the usual
time, it can be injected within 12 hours of
the normally scheduled time. Patients should not administer more than
one injection in the same day and
should not try to make up for a missed dose.
T
3
_Special populations _
_Elderly patients _
Dose a
djustment based on age is not required (see section 5.2).
_Renal impairment _
Abaloparatide must not be used in patients with severe renal
impairment including patients with end-stage
renal disease (see section 4.3). In patients with mild to moderate
renal impairment, dose-based adjustment
is not required (see section 5.2).
_Hepatic impairment _
No data are available in