Zoledronic acid Oresund Pharma 4 mg/100 ml Infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

zoledronsyramonohydrat

Tillgänglig från:

Øresund Pharma ApS

ATC-kod:

M05BA08

INN (International namn):

zoledronic

Dos:

4 mg/100 ml

Läkemedelsform:

Infusionsvätska, lösning

Sammansättning:

mannitol Hjälpämne; zoledronsyramonohydrat 4,264 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Infusionspåse, 1 st (1 x 100 ml)

Bemyndigande status:

Godkänd

Tillstånd datum:

2016-11-07

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID ORESUND PHARMA 4 MG/100 ML SOLUTION FOR INFUSION
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 is and what it is used for
2. What you need to know before you are given
3. How is used
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
The active substance in 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
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN :

if you are breast-feeding.

if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to
which belongs), or any of the other ingredients of
this medicine (lis

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Oresund Pharma 4 mg/100 ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag of solution contains zoledronic acid monohydrate
corresponding to 4 mg
zoledronic acid.
Each ml of solution contains 0.04 mg zoledronic acid.
This medicinal product contains 1.7-2.6 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution
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

must
only
be
prescribed
and
administered
to
patients
by
healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated
with Zoledronic Acid 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 _
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: _
treatment in TIH patients who also have severe renal
impairment should be
considered only after evaluating t