Iasibon

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

ibandronic acid

Saatavilla:

Pharmathen S.A.

ATC-koodi:

M05BA06

INN (Kansainvälinen yleisnimi):

ibandronic acid

Terapeuttinen ryhmä:

Drugs for treatment of bone diseases

Terapeuttinen alue:

Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms

Käyttöaiheet:

Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.,

Tuoteyhteenveto:

Revision: 11

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-01-21

Pakkausseloste

72
B. PACKAGE LEAFLET
73
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IASIBON 1 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ibandronic acid
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, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible
side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
:
1.
What Iasibon is and what it is used for
2.
What you need to know before you receive Iasibon
3.
How to receive Iasibon
4.
Possible side effects
5.
How to store Iasibon
6.
Contents of the pack and other information
1.
WHAT IASIBON IS AND WHAT IT IS USED FOR
Iasibon contains the active substance ibandronic acid. This belongs to
a group of medicines called
bisphosphonates.
Iasibon is used in adults and prescribed to you if you have breast
cancer that has spread to your bones
(called ‘bone metastases’).
•
It helps to prevent your bones from breaking (fractures)
•
It helps to prevent other bone problems that may need surgery or
radiotherapy
Iasibon can also be prescribed if you have a raised calcium level in
your blood due to a tumour.
Iasibon works by reducing the amount of calcium that is lost from your
bones. This helps to stop your
bones from getting weaker.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE IASIBON
DO NOT RECEIVE IASIBON
•
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine that are
listed in section 6
•
if you have, or have ever had low levels of calcium in your blood.
Do not receive this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or
pharmacist before having Iasibon.
WARNINGS AND PRECAUTIONS
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in
the jaw) has been reported very
rarely in the post marketing setting in patients receiving ib

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Iasibon 1 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule with 1 mL concentrate for solution for infusion contains 1
mg ibandronic acid (as sodium
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Iasibon is indicated in adults for
-
Prevention of skeletal events (pathological fractures, bone
complications requiring radiotherapy
or surgery) in patients with breast cancer and bone metastases
-
Treatment of tumour-induced hypercalcaemia with or without metastases
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Iasibon therapy should only be initiated by physicians experienced in
the treatment of cancer.
Posology
_Prevention of skeletal events in patients with breast cancer and bone
metastases_
The recommended dose for prevention of skeletal events in patients
with breast cancer and bone
metastases is 6 mg intravenous injection given every 3-4 weeks. The
dose should be infused over at
least 15 minutes.
A shorter (i.e. 15 min) infusion time should only be used for patients
with normal renal function or mild
renal impairment. There are no data available characterising the use
of a shorter infusion time in
patients with creatinine clearance below 50 mL/min. Prescribers should
consult the section
_Patients with _
_Renal Impairment _
(see section 4.2) for recommendations on dosing and administration in
this patient
group.
_Treatment of tumour-induced hypercalcaemia_
Prior to treatment with Iasibon the patient should be adequately
rehydrated with 9 mg/mL (0.9%)
sodium chloride solution. Consideration should be given to the
severity of the hypercalcaemia as well as
the tumour type. In general patients with osteolytic bone metastases
require lower doses than patients
with the humoral type of hypercalcaemia. In most patients with severe
hypercalcaemia