Tasigna 200 mg

Land: Jordanië

Taal: Engels

Bron: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Werkstoffen:

Nilotinib 200 mg

Beschikbaar vanaf:

شركة مستودع الأدوية الأردني - The Jordan Drugstore Co

ATC-code:

L01XE08

INN (Algemene Internationale Benaming):

Nilotinib 200 mg

Dosering:

200 mg

Eenheden in pakket:

112 Caps

Geproduceerd door:

NOVARTIS PHARMA STEIN AG /SWI (سويسرا)

Bijsluiter

PRESCRIBING INFORMATION FOR HUMAN MEDICINES
Novartis Pharma Schweiz AG
Confidential
Application no.:
TASIGNA®
COMPOSITION
_Active substances _
Nilotinib as nilotinib hydrochloride monohydrate.
_Excipients _
_Capsule contents – 50/150/200 mg capsules: _
Lactose
monohydrate,
(50/150/200 mg
capsules:
39/117/156 mg),
crospovidone,
poloxamer, colloidal silicone dioxide, magnesium stearate.
_Capsule shell_ _– 50 mg and 150 mg capsules_:
Gelatin, titanium dioxide (E171), iron oxide (E172, red), iron oxide
(E172, yellow).
_Capsule shell –200 mg capsules_:
Gelatin, titanium dioxide (E171), iron oxide (E172, yellow).
_Printing ink – 50 mg and 150 mg capsules: _
Shellac (E904), iron oxide (E172, black), propylene glycol, ammonium
hydroxide.
_Printing ink – 200 mg capsules: _
Two different printing inks may be used on the 200 mg capsules.
Printing ink a: Shellac (E904), iron oxide (E172, red), propylene
glycol, ammonium
hydroxide.
Printing ink b: Shellac (E904), iron oxide (E172, red), propylene
glycol, iron oxide (E172,
black), titanium dioxide (E171).
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
_50 mg hard capsules _
White to yellowish powder in hard gelatin capsules with red opaque cap
and light yellow
opaque body, size 4, with black radial imprint “NVR/ABL” on cap.
_Capsules containing 150 mg nilotinib: _
PRESCRIBING INFORMATION FOR HUMAN MEDICINES
Novartis Pharma Schweiz AG
Confidential
Application no.:
White to yellowish powder in red opaque hard gelatin capsules, size 1,
with black axial
imprint “NVR/BCR”.
_Capsules containing 200 mg nilotinib: _
White to yellowish powder in light yellow opaque hard gelatin
capsules, size 0, with red
axial imprint “NVR/TKI”.
INDICATIONS/POTENTIAL USES
•
First-line treatment of adult patients and paediatric patients aged 2
years and over with
Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML)
in chronic
phase.
•
Treatment of Philadelphia chromosome-positive chronic myeloid
leukaemia (Ph+
CML) in chronic or accelerated phase