Desinobon 4 mg/5 ml, concentraat voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ZOLEDRONINEZUUR 1-WATER SAMENSTELLING overeenkomend met ; ZOLEDRONINEZUUR 0-WATER

Beschikbaar vanaf:

Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)

ATC-code:

M05BA08

INN (Algemene Internationale Benaming):

Zoledronic acid 1-WATER COMPOSITION corresponding to ; zoledronic acid 0-WATER

farmaceutische vorm:

Concentraat voor oplossing voor infusie

Samenstelling:

MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Zoledronic Acid

Product samenvatting:

Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Autorisatie datum:

2012-09-25

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
DESINOBON 4 MG/5 ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
Zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 DESINOBON is and what it is used for
2.
What you need to know before you are given DESINOBON
3.
How DESINOBON is used
4.
Possible side effects
5.
How to store DESINOBON
6.
Contents of the pack and other information
1.
WHAT DESINOBON IS AND WHAT IT IS USED FOR
The active substance in Desinobon is zoledronic acid, which belongs to
a group of substances called
bisphosphonates. Zoledronic acid works by attaching itself to the bone
and slowing down the rate of
bone change. It is used:

TO PREVENT BONE COMPLICATIONS, e.g. fractures, in adult patients with
bone metastases (spread
of cancer from primary site to the bone).

TO REDUCE THE AMOUNT OF CALCIUM in the blood in adult patients where
it is too high due to the
presence of a tumour. Tumours can accelerate normal bone change in
such a way that the
release of calcium from bone is increased. This condition is known as
tumour-induced
hypercalcaemia (TIH).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DESINOBON
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Desinobon and will check your
response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN DESINOBON:
-
if you are breast-feeding.
-
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Desinobon belongs), or any of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor befor

Productkenmerken

1
_Version 4, 02/2016_
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
Desinobon 4 mg/5 ml, concentraat voor oplossing voor infusie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic
acid monohydrate.
One ml concentrate contains 0.8 mg zoledronic acid.
Excipient with known effect:
5 ml concentrate contains 0.0816 mmol of sodium citrate dihydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
_ _
Clear, colourless solution, free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prevention of skeletal related events (pathological fractures, spinal
compression, radiation or
surgery to bone, or tumour-induced hypercalcaemia) in adult patients
with advanced
malignancies involving bone.
-
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Desinobon must only be prescribed and administered to patients by
healthcare professionals
experienced in the administration of intravenous bisphosphonates.
Patients treated with Desinobon
should be given the package leaflet and the patient reminder card.
Posology
_Prevention of skeletal related events in patients with advanced
malignancies involving bone _
_Adults and older people _
The recommended dose in the prevention of skeletal related events in
patients with advanced
malignancies involving bone is 4 mg zoledronic acid every 3 to 4
weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D
daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should
consider that the onset of treatment effect is 2-3 months.
_Treatment of TIH _
_Adults and older people _
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium ≥ 12.0 mg/dl or 3.0
mmol/l) is a single dose of 4 mg zoledronic acid.
3
_Renal impairment _
_TIH: _
Des