Jakavi 15mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ruxolitinib phosphate

Saatavilla:

Novartis Pharmaceuticals UK Ltd

ATC-koodi:

L01XE18

INN (Kansainvälinen yleisnimi):

Ruxolitinib phosphate

Annos:

15mg

Lääkemuoto:

Tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 08010500; GTIN: 5010678910025 5010678910056

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JAKAVI 5 MG TABLETS
JAKAVI 10 MG TABLETS
JAKAVI 15 MG TABLETS
JAKAVI 20 MG TABLETS
ruxolitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Jakavi is and what it is used for
2.
What you need to know before you take Jakavi
3.
How to take Jakavi
4.
Possible side effects
5.
How to store Jakavi
6.
Contents of the pack and other information
1.
WHAT JAKAVI IS AND WHAT IT IS USED FOR
Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat adult patients with an enlarged spleen or with
symptoms related to myelofibrosis,
a rare form of blood cancer.
Jakavi is also used to treat patients with polycythaemia vera who are
resistant to or intolerant of
hydroxyurea.
HOW JAKAVI WORKS
Enlargement of the spleen is one of the characteristics of
myelofibrosis. Myelofibrosis is a disorder of
the bone marrow, in which the marrow is replaced by scar tissue. The
abnormal marrow can no longer
produce enough normal blood cells and as a result the spleen becomes
significantly enlarged. By
blocking the action of certain enzymes (called Janus Associated
Kinases), Jakavi can reduce the size of
the spleen in patients with myelofibrosis and relieve symptoms such as
fever, night sweats, bone pain
and weight loss in patients with myelofibrosis. Jakavi can help reduce
the risk of serious blood or
vascular complications.
Polycythaemia vera is a disorder of the bone marrow, in which the
marrow produce too many red blood
cells. The blood becomes thicker as a result of

Valmisteyhteenveto

OBJECT 1
JAKAVI 15MG TABLETS
Summary of Product Characteristics Updated 13-Jun-2018 | Novartis
Pharmaceuticals UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Jakavi
®
5 mg tablets
Jakavi
®
10 mg tablets
Jakavi
®
15 mg tablets
Jakavi
®
20 mg tablets
2. Qualitative and quantitative composition
Jakavi 5 mg tablets
Each tablet contains 5 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 71.45 mg lactose monohydrate.
Jakavi 10 mg tablets
Each tablet contains 10 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 142.90 mg lactose monohydrate.
Jakavi 15 mg tablets
Each tablet contains 15 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 214.35 mg lactose monohydrate.
Jakavi 20 mg tablets
Each tablet contains 20 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 285.80 mg lactose monohydrate.
For the full list of excipients, see section 6.