ACLASTA

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

ZOLEDRONIC ACID

Dostupno od:

NOVARTIS ISRAEL LTD

ATC koda:

M05BA08

Farmaceutski oblik:

SOLUTION FOR INFUSION

Sastav:

ZOLEDRONIC ACID 5 MG / 100 ML

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Terapijska grupa:

ZOLEDRONIC ACID

Područje terapije:

ZOLEDRONIC ACID

Terapijske indikacije:

Treatment of Paget's disease of the bone. Treatment of osteoporosis : - in post-menopausal women - in men at increased risk of fracture including those with a recent low-trauma hip fracture.Treatment and prevention of glucocorticoid-induced osteoporosis.Prevention of postmenopausal osteoporosis in women for whom bisphosphonate therapy is indicated.

Datum autorizacije:

2022-01-31

Uputa o lijeku

SH ACL APL DEC20 V2
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
ACLASTA
®
SOLUTION FOR INTRAVENOUS
INFUSION (I.V.)
ZOLEDRONIC ACID 5 MG/100 ML
Each vial of 100 ml solution contains 5 mg zoledronic
acid (anhydrous).
INACTIVE AND ALLERGENIC INGREDIENTS IN THE
PREPARATION - see chapter 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your
ailment. Do not pass it on to others. It may harm them
even if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Aclasta is used for:
∙ Treatment of Paget’s disease of the bone.
∙ Treatment of osteoporosis:
∘ in postmenopausal women
∘ in men
who are at increased risk of fracture, including those
with a recent hip fracture from a minor injury.
∙ Treatment and prevention of glucocorticoid-induced
osteoporosis (a type of steroids).
∙ Prevention of postmenopausal osteoporosis in women
for whom bisphosphonate therapy is indicated.
THERAPEUTIC GROUP: bisphosphonates.
Osteoporosis:
Osteoporosis is a disease that causes thinning and
weakening of the bones and is common in women
after menopause, but can also occur in men. At
menopause, a woman’s ovaries stop producing the
female hormone estrogen, which helps keep bones
healthy. After menopause, bone loss occurs, the bones
become weaker and break more easily. Osteoporosis
could also occur in men and women because of the
long-term use of steroids, which can affect the strength
of bones. Many patients with osteoporosis have no
symptoms, but they are still at risk of breaking bones
because osteoporosis has made their bones weaker.
Decreased blood levels of sex hormones, mainly
estrogens formed from androgens, also play a role
in the more gradual bone loss observed

Svojstava lijeka

ACL API MAY21 V13
Page 1 of 17
EU SmPC Mar2021, NZ DS AUG 2020
1.
NAME OF THE MEDICINAL PRODUCT
Aclasta
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as
monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of Paget’s disease of the bone.

Treatment of osteoporosis:
• in post-menopausal women
• in men
at increased risk of fracture, including those with a recent
low-trauma hip fracture.

Treatment and prevention of glucocorticoid-induced osteoporosis.

Prevention of post-menopausal osteoporosis in women for whom
bisphosphonate therapy is indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients must be appropriately hydrated prior to administration of
Aclasta. This is especially important for the
elderly (≥65 years) and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with Aclasta administration.
_Osteoporosis _
For the treatment of post-menopausal osteoporosis, osteoporosis in men
and the treatment and prevention of
osteoporosis associated with long-term systemic glucocorticoid
therapy, the recommended dose is a single
intravenous infusion of 5 mg Aclasta administered once a year.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for
continued treatment should be re-evaluated periodically based on the
benefits and potential risks of Aclasta on
an individual patient basis, particularly after 5 or more years of
use.
In patients with a recent low-trauma hip fracture, it is recommended
to give the Aclasta infusion at least two
weeks after hip fracture repair (see section 5.1). In patients with a
recent low-trauma hip fracture, a loading dose
of 50 000 to 125 000 IU of vitamin D given oral