EVEROLIMUS SANDOZ everolimus 5 mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

everolimus, Quantity: 5 mg

Dostupné s:

Novartis Pharmaceuticals Australia Pty Ltd

Léková forma:

Tablet, uncoated

Složení:

Excipient Ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose

Podání:

Oral

Jednotky v balení:

60 Tablets, 50 Tablets, 100 Tablets, 120 Tablets, 30 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

EVEROLIMUS SANDOZ is indicated for the treatment of:,? Postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? Advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. ? Patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery.

Přehled produktů:

Visual Identification: White to slightly yellowish, elongated tablet with a bevelled edge. One side debossed with 'NVR' and the other side with '5'.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Licence status A

Datum autorizace:

2018-02-01

Informace pro uživatele

EVEROLIMUS
SANDOZ
®
_everolimus_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EVEROLIMUS
SANDOZ.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
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.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
EVEROLIMUS SANDOZ against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EVEROLIMUS
SANDOZ IS USED FOR
EVEROLIMUS SANDOZ is used in
the treatment of renal cell carcinoma,
a type of kidney cancer;
neuroendocrine tumours (NETs), a
type of cancer located in the stomach
and intestine, lung or pancreas;
tuberous sclerosis complex (TSC)
with angiomyolipoma of the kidney
(a kidney tumour) not requiring
immediate surgery; or TSC with
subependymal giant cell astrocytoma
(sometimes called 'SEGA'), a specific
type of brain tumour not requiring
immediate surgery.
EVEROLIMUS SANDOZ is also
used in the treatment of hormone
receptor-positive HER2 negative
advanced breast cancer in
postmenopausal women, in
conjunction with exemestane after
failure of letrozole or anastrozole.
It is only used in patients whose
tumour has tested negative to HER2.
Everolimus is the active substance in
EVEROLIMUS SANDOZ.
TREATMENT OF KIDNEY CANCER
EVEROLIMUS SANDOZ stops the
cancer from making new cells and
cuts off the blood supply. This slows
the growth and spread of the cancer.
TREATMENT OF NETS

Charakteristika produktu

1
AUSTRALIAN PI – EVEROLIMUS SANDOZ (EVEROLIMUS) TABLETS
1
NAME OF THE MEDICINE
Everolimus.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Everolimus Sandoz tablet contains either 2.5 mg, 5 mg or 10 mg
everolimus.
Excipients: with known effect: contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
2.5 mg tablet: White to slightly yellowish, elongated tablet with a
bevelled edge and no score engraved
with “LCL” on one side and “NVR” on the other.
5 mg tablet: White to slightly yellowish, elongated tablet with a
bevelled edge and no score engraved with
“5” on one side and “NVR” on the other.
10 mg tablet: White to slightly yellowish, elongated tablet with a
bevelled edge and no score engraved
with “UHE” on one side and “NVR” on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Everolimus Sandoz is indicated for the:
•
Treatment of postmenopausal women with hormone receptor-positive, HER2
negative advanced
breast cancer in combination with exemestane after failure of
treatment with letrozole or
anastrozole.
•
Treatment
of
progressive,
unresectable
or
metastatic,
well
or
moderately
differentiated
neuroendocrine tumours (NETs) of pancreatic origin.
•
Treatment
of
progressive,
unresectable
or
metastatic,
well-differentiated,
non-functional
neuroendocrine tumours (NET) of gastrointestinal or lung origin in
adults.
•
Treatment of advanced renal cell carcinoma after failure of treatment
with sorafenib or sunitinib.
•
Treatment of subependymal giant cell astrocytoma (SEGA) associated
with tuberous sclerosis
complex (TSC) who require therapeutic intervention but are not
candidates for curative surgical
resection.
•
Treatment of patients with tuberous sclerosis complex (TSC) who have
renal angiomyolipoma not
requiring immediate surgery.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with Everolimus Sandoz should be initiated by a physician
experienced in the use of anticancer
therapies or in the treatment