Jakavi

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5 mg;  

Saadav alates:

Novartis New Zealand Ltd

INN (Rahvusvaheline Nimetus):

Ruxolitinib phosphate 6.6 mg (= ruxolitinib 5 mg)

Annus:

5 mg

Ravimvorm:

Tablet

Koostis:

Active: Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5 mg   Excipient: Colloidal silicon dioxide Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Sodium starch glycolate

Retsepti tüüp:

Prescription

Valmistatud:

Novartis Ringaskiddy Ltd

Näidustused:

Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE(Aclar)/Al - 14 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PCTFE(Aclar)/Al - 28 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PCTFE(Aclar)/Al - 56 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PCTFE(Aclar)/Al - 112 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PCTFE(Aclar)/Al - 168 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PCTFE(Aclar)/Al - 224 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture

Loa andmise kuupäev:

2013-12-13

Infovoldik

Jakavi®
1
JAKAVI
®
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.
1.
WHY AM I USING JAKAVI?
Jakavi contains the active ingredient ruxolitinib (as phosphate).
Jakavi is used to treat adults with myelofibrosis, adults with
polycythemia vera, and patients 12 years and older with
graft-versus-host disease (GvHD).
For more information, see Section 1. Why am I using Jakavi? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE JAKAVI?
Do not take if you have ever had an allergic reaction to ruxolitinib
or any of the ingredients listed at the end of the CMI.
BEFORE YOU START TAKING JAKAVI, YOUR DOCTOR WILL DO SOME BLOOD TESTS.
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
Jakavi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Jakavi 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 JAKAVI?
•
Take Jakavi twice a day. Your doctor will tell you how many tablets to
take.
•
Jakavi tablets are to be taken by mouth, either with or without food.
Swallow the tablets whole with a glass of water.
More instructions can be found in Section 4. How do I use Jakavi? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING JAKAVI?
THINGS YOU
SHOULD DO
•
Keep all of your doctor's appointments so that your progress can be
checked
•
Remind any doctor, dentist, anaesthetist or pharmacist you visit that
you are using Jakavi.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking this medicine
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING OR USING
MACHINES
•
Do not drive or use machinery if you feel

Toote omadused

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Jakavi tablets: 5 mg, 10 mg, 15 mg and 20 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
•
5 MG:
Each tablet contains 5 mg of ruxolitinib as the phosphate salt.
•
10 MG:
Each tablet contains 10 mg of ruxolitinib as the phosphate salt
•
15 MG
: Each tablet contains 15 mg of ruxolitinib as the phosphate salt.
•
20 MG:
Each tablet contains 20 mg of ruxolitinib as the phosphate salt.
EXCIPIENT WITH KNOWN EFFECT:
these tablets contain sugars as lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
5MG TABLET:
Round curved white to almost white tablets of approximately 7.5 mm in
diameter
with “NVR” debossed on one side and “L5” debossed on the other
side.
10MG TABLET:
Round curved white to almost white tablets of approximately 9.3 mm in
diameter
with “NVR“ debossed on one side and “L10” debossed on the
other side.
15 MG TABLET:
Ovaloid curved white to almost white tablets of approximately 15.0 x
7.0 mm
with “NVR” debossed on one side and “L15” debossed on the
other side.
20 MG TABLET:
Elongated curved white to almost white tablets of approximately 16.5 x
7.4 mm
with “NVR” debossed one one side and “L20” debossed on the
other side.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Jakavi is indicated for the treatment of disease-related splenomegaly
or symptoms in
patients with primary myelofibrosis, post-polycythemia vera
myelofibrosis or post-
essential thrombocythemia myelofibrosis.
•
Jakavi is indicated for the treatment of adult patients with
polycythemia vera who are
resistant to or intolerant of hydroxyurea.
•
Jakavi is indicated for the treatment of patients aged 12 years and
older with acute graft-
versus-host disease who have inadequate response to corticosteroids.
•
Jakavi is indicated for the treatment of patients aged 12 years and
older with chronic
graft-versus-host disease who have inadequate response to
corticosteroids.
4.2
DOSE AND METHOD OF ADMINISTRATION
Doses should be indivi