Zoledronic acid Viatris

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Zoledronic acid monohydrate 0.8528 mg/mL equivalent to zoledronic acid 0.8 mg/mL;  

Disponible des:

Viatris Limited

Designació comuna internacional (DCI):

Zoledronic acid monohydrate 0.8528 mg/mL (= zoledronic acid 0.8 mg/mL)

Dosis:

4 mg/5mL

formulario farmacéutico:

Concentrate for infusion

Composición:

Active: Zoledronic acid monohydrate 0.8528 mg/mL equivalent to zoledronic acid 0.8 mg/mL   Excipient: Hydrochloric acid Sodium citrate Sodium hydroxide Water for injection

Unidades en paquete:

Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap, 1

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Sun Pharmaceutical Industries Ltd

indicaciones terapéuticas:

· Treatment of tumour-induced hypercalcaemia.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 4 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data d'autorització:

2011-11-18

Informació per a l'usuari

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ZOLEDRONIC ACID VIATRIS
_ZOLEDRONIC ACID CONCENTRATE FOR INFUSION 4MG/5ML_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start being given
Zoledronic Acid Viatris.
This leaflet answers some common
questions about Zoledronic Acid
Viatris.
The information in this leaflet was
last updated on the date listed on
the final page. More recent
information on the medicine may be
available.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
Zoledronic Acid Viatris against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ZOLEDRONIC
ACID VIATRIS IS USED
FOR
Zoledronic Acid Viatris is used to
lower the amount of calcium in the
blood when it becomes too high, as
may happen in some forms of
cancer.
Some cancers can speed up normal
changes in bone so that the amount
of calcium released from the bones
into the blood is increased.
Zoledronic Acid Viatris is also used
to slow down the spread of cancers
in bone, helping to prevent changes
to the bones that may cause them
to weaken.
Zoledronic Acid Viatris contains the
active ingredient zoledronic acid. It
belongs to a group of medicines
called bisphosphonates, which
strongly bind to bone. These
medicines slow down the rate of
bone change and help to restore the
amount of calcium in the blood to
normal levels.
It is used in people with advanced
cancer of the bone marrow (called
multiple myeloma) and other
advanced cancers that have spread
to the bone. This medicine is used
in addition to other standard cancer
treatments.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available

Fitxa tècnica

Page 1 of 17
NEW ZEALAND DATA SHEET
ZOLEDRONIC ACID VIATRIS
1. PRODUCT NAME
ZOLEDRONIC ACID VIATRIS, 4 mg/ 5 mL, concentrate for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for infusion contains 0.8 mg of zoledronic acid
(calculated as the anhydrous
form, corresponding to 0.8528 mg zoledronic acid monohydrate).
Each 5 mL vial contains 4 mg of zoledronic acid (calculated as the
anhydrous form, corresponding
to 4.264 mg zoledronic acid monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ZOLEDRONIC ACID VIATRIS concentrate for infusion is a sterile clear
and colourless solution.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ADULTS

Prevention
of
skeletal-related
events
(pathological
fracture,
spinal
cord
compression,
radiation to bone or surgery to bone) in patients with advanced
malignancies involving bone.

Treatment of tumour-induced hypercalcaemia.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ZOLEDRONIC ACID VIATRIS concentrate for infusion must not be mixed
with calcium or other
divalent cation-containing infusion solutions, such as Lactated
Ringer’s solution, and should be
administered as a single intravenous solution in a line separate from
all other drugs.
PREVENTION
OF
SKELETAL
RELATED
EVENTS
IN
PATIENTS
WITH
ADVANCED
MALIGNANCIES
INVOLVING BONE
In adults and elderly patients the recommended dose in the prevention
of skeletal related events in
patients with advanced malignancies involving bone is 4 mg zoledronic
acid. The concentrate must
be further diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v
glucose solution and given as an
intravenous infusion lasting no less than 15 minutes every 3 to 4
weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D
daily.
Page 2 of 17
TREATMENT OF TUMOUR-INDUCED HYPERCALCEMIA (TIH)
In adults and elderly patients the recommended dose in hypercalcemia
(albumin-corrected serum
calcium ≥12.0 mg/dL or 3.0 mmol/L) is 4 mg zoledronic acid. The