AFINITOR everolimus 5 mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

everolimus, Quantity: 5 mg

Commercializzato da:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Nome Internazionale):

Everolimus

Forma farmaceutica:

Tablet, uncoated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

60 TABLETS, 30 TABLETS, 120 TABLETS, 100 TABLETS, 50 TABLETS

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Afinitor 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. ? Adjunctive treatment of patients aged 2 years and older with TSC and associated refractory seizures.

Dettagli prodotto:

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: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2009-08-06

Foglio illustrativo

AFINITOR
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING AFINITOR?
Afinitor contains the active ingredient everolimus. Afinitor is used
to treat various types of cancer by slowing the growth of cancer-
causing cells.
For more information, see Section 1. Why am I using Afinitor? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AFINITOR?
Do not use if you have ever had an allergic reaction to Afinitor or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Afinitor? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Afinitor and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE AFINITOR?
•
Your doctor will tell you the dose of Afinitor that you should take.
More instructions can be found in Section 4. How do I use Afinitor? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AFINITOR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Afinitor.
•
Avoid becoming pregnant while using Afinitor and for up to 8 weeks
after you stop using it.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take Afinitor to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
It is not known if Afinitor will influence your ability to drive and
use machines.
DRINKING
ALCOHOL
•
There are no known interactions bet

Scheda tecnica

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN
PI
–
AFINITOR
(EVEROLIMUS)
TABLETS
AND
DISPERSIBLE TABLETS
1
NAME OF THE MEDICINE
Everolimus.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Afinitor tablet contains either 2.5 mg, 5 mg or 10 mg everolimus.
Each Afinitor dispersible tablet contains either 2 mg, 3 mg or 5 mg
everolimus.
Excipients with known effect: tablets only - 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.
2 mg dispersible tablet: White to slightly yellowish, round, flat
tablets with a bevelled edge and no
score. The tablets are engraved with “D2” on one side and
“NVR” on the other.
3 mg dispersible tablet: White to slightly yellowish, round, flat
tablets with a bevelled edge and no
score. The tablets are engraved with “D3” on one side and
“NVR” on the other.
5 mg dispersible tablet: White to slightly yellowish, round, flat
tablets with a bevelled edge and no
score. The tablets are engraved with “D5” on one side and
“NVR” on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Afinitor 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.
▼

2
•
Tre