INLYTA

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Axitinib 1mg;  

Предлага се от:

Pfizer New Zealand Limited

INN (Международно Name):

Axitinib 1 mg

дозиране:

1 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Axitinib 1mg   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry red 32K15441

Броя в опаковка:

Blister pack, Al/Al foil, 28 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Pfizer Ireland Pharmaceuticals

Терапевтични показания:

Treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, Al/Al foil - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, HDPE with desiccant - 180 tablets - 36 months from date of manufacture stored at or below 30°C

Дата Оторизация:

2012-10-15

Листовка

INLYTA
®
1
INLYTA
®
_Axitinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INLYTA.
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 taking INLYTA
against the benefits it is expected to
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 INLYTA IS USED
FOR
_WHAT INLYTA DOES _
INLYTA is used to treat a certain
type of kidney cancer called renal
cell carcinoma (RCC).
It belongs to a group of medicines
called tyrosine kinase inhibitors.
_HOW INLYTA WORKS _
INLYTA contains the active
substance axitinib. It works by
reducing the blood supply to the
tumour and slowing down the growth
of cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INLYTA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
INLYTA is only available with a
doctor's prescription. It is not
addictive.
_USE IN CHILDREN _
The safety and efficacy of INLYTA
have not been established in children.
BEFORE YOU TAKE
INLYTA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE INLYTA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing axitinib
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS,

Данни за продукта

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INLYTA
®
axitinib 1 mg film-coated tablets
INLYTA axitinib 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INLYTA 1 MG FILM-COATED TABLET
Each tablet contains 1 mg axitinib.
EXCIPIENTS WITH KNOWN EFFECT
Each tablet contains 32 mg lactose monohydrate.
INLYTA 5 MG FILM-COATED TABLET
Each tablet contains 5 mg axitinib.
EXCIPIENTS WITH KNOWN EFFECT
Each tablet contains 56 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
INLYTA 1 mg film-coated tablets: red, film-coated, oval tablets,
debossed with “Pfizer” on
one side and “1 XNB” on the other.
INLYTA 5 mg film-coated tablets: red, film-coated, triangular tablets,
debossed with “Pfizer”
on one side and “5 XNB” on the other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INLYTA is indicated for the treatment of patients with advanced renal
cell carcinoma after
failure of one prior systemic therapy.
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4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSE
The recommended starting oral dose of INLYTA is 5 mg twice daily.
INLYTA may be taken
with or without food.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next
prescribed dose should be taken at the usual time.
DOSE ADJUSTMENT
Dose increase or reduction is recommended based on individual safety
and tolerability.
Patients who tolerate the INLYTA starting dose of 5 mg twice daily
with no adverse
reactions > Grade 2 (according to the Common Toxicity Criteria for
Adverse Events
[CTCAE]) for two consecutive weeks, are normotensive, and are not
receiving anti-
hypertensive medication, may have their dose increased to 7 mg twice
daily. Subsequently,
using the same criteria, patients who tolerate the INLYTA dose of 7 mg
twice daily, may
have their dose increased to a maximum of 10 mg twice daily.
Management of some adverse drug reactions may r