Bondronat
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
14-07-2023
Karatteristiċi tal-prodott
(SPC)
14-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
13-05-2016
Ingredjent attiv:
ibandronic acid
Disponibbli minn:
Atnahs Pharma Netherlands B.V.
Kodiċi ATC:
M05BA06
INN (Isem Internazzjonali):
ibandronic acid
Grupp terapewtiku:
Drugs for treatment of bone diseases
Żona terapewtika:
Hypercalcemia; Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Indikazzjonijiet terapewtiċi:
Bondronat is indicated 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.
Sommarju tal-prodott:
Revision: 32
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
1996-06-25
Fuljett ta 'informazzjoni
54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BONDRONAT 2 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 Bondronat is and what it is used for
2.
What you need to know before you receive Bondronat
3.
How to receive Bondronat
4.
Possible side effects
5.
How to store Bondronat
6.
Contents of the pack and other information
1.
WHAT BONDRONAT IS AND WHAT IT IS USED FOR
Bondronat contains the active substance ibandronic acid. This belongs
to a group of medicines called
bisphosphonates.
Bondronat 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.
Bondronat can also be prescribed if you have a raised calcium level in
your blood due to a tumour.
Bondronat 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 BONDRONAT
DO NOT RECEIVE BONDRONAT:
•
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 Bondronat.
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 set
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bondronat 2 mg concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One vial with 2 ml concentrate for solution for infusion contains 2 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
Bondronat 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
Patients treated with Bondronat should be given the package leaflet
and the patient reminder card.
Bondronat 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 Bondronat 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 l
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