Zoledroninezuur Genericon 4 mg/100 ml, 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:

GENERICON PHARMA Gesellschaft m.b.H. Hafnerstrasse 211 A-8054 GRAZ (OOSTENRIJK)

ATC-code:

M05BA08

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

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:

2013-08-12

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledroninezuur Genericon 4mg/100ml, 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 Zoledroninezuur Genericon is and what it is used for
2.
What you need to know before you are given Zoledroninezuur Genericon
3.
How Zoledroninezuur Genericon is used
4.
Possible side effects
5.
How to store Zoledroninezuur Genericon
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONINEZUUR GENERICON IS AND WHAT IT IS USED FOR
The active substance in Zoledroninezuur Genericon 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 ZOLEDRONINEZUUR GENERICON
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledroninezuur
Genericon and will check your response to treatment at regular
intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONINEZUUR GENERICON:
− if you are breast-feeding.
− if you are allergic (hypersensitive) to zoledronic acid, another
bisphosphonate (the
group of su

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zoledroninezuur Genericon 4 mg/100 ml, oplossing voor infusie
2. QUALITATIVE AND QUANTITAVE COMPOSITION
One vial contains 4 mg zoledronic acid, corresponding to 4.26 mg
zoledronic acid
monohydrate.
This medicinal product contains less than 1 mmol sodium (23 mg) per
infusion, i.e.
essentially ’sodium-free’.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution
pH:
5.5-7.0
Osmolarity:
0.27-0.33 Osmol /kg
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
Zoledroninezuur Genericon must only be prescribed and administered to
patients by
healthcare professionals experienced in the administration of
intravenous
bisphosphonates. Patients treated with Zoledroninezuur Genericon
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 elderly _
2
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 elderly _
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.
_Renal impairment _
_TIH: _
Zoledroninezuur Genericon treatment in TIH patients who al