ACLASTA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ZOLEDRONIC ACID

Disponível em:

NOVARTIS ISRAEL LTD

Código ATC:

M05BA08

Forma farmacêutica:

SOLUTION FOR INFUSION

Composição:

ZOLEDRONIC ACID 5 MG / 100 ML

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

FRESENIUS KABI AUSTRIA GmbH

Área terapêutica:

ZOLEDRONIC ACID

Indicações terapêuticas:

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.

Data de autorização:

2017-02-12

Folheto informativo - Bula

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