AKYNZEO

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NETUPITANT; PALONOSETRON AS HYDROCHLORIDE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

A04AA55

الشكل الصيدلاني:

CAPSULES

تركيب:

NETUPITANT 300 MG; PALONOSETRON AS HYDROCHLORIDE 0.50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HELSINN BIREX PHARMACEUTICALS, LTD., IRELAND

المجال العلاجي:

PALONOSETRON, COMBINATIONS

الخصائص العلاجية:

Prevention of Acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

تاريخ الترخيص:

2021-03-31

نشرة المعلومات

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only.
AKYNZEO
CAPSULES
ACTIVE INGREDIENTS:
Each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron
as hydrochloride salt.
For the list of the other ingredients, see section 6. See also
'Important information about some of the
medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine was prescribed for treating your condition. Do not pass
it on to others. It may harm
them, even if you think their medical condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for prevention of nausea and vomiting as an
immediate or delayed
result of chemotherapy.
THERAPEUTIC GROUP:
Anti-nausea and vomiting agents: Netupitant – blocks substance P
from binding to neurokinin 1
(NK-1) receptor, Palonosetron – blocking serotonin (5-HT
3
) receptor.
By blocking the activity of substance P and serotonin, the medicine
prevents stimulation of the
vomiting center and as a result, also the feeling of nausea.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients or to any of
the other ingredients the medicine
contains (for a list of the other ingredients, see section 6).
•
You are pregnant.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TREATMENT WITH THE MEDICINE TELL YOUR DOCTOR IF:
•
You suffer from liver problems.
•
You suffer from bowel obstruction or have suffered in the past from
constipation.
•
You or someone in your family suffer or have suffered in the past from
a heart problem called QT interval
prolongation, or if you suffer from any other heart problem.
•
You suffer from imbalance of salts (electrolytes) in your blood (e.g.
potassium or magnesium).
USE IN CHILDREN:
There

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Akynzeo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg of netupitant, and 0.56 mg palonosetron
hydrochloride equivalent to
0.5 mg of palonosetron.
Excipients with known effect:
Each capsule contains 7 mg of sorbitol and 20 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Opaque gelatin capsule with white body and caramel cap with “HE1”
printed on the body. The hard
capsule is filled with three tablets and one soft capsule.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Akynzeo is indicated for the prevention of acute and delayed nausea
and vomiting associated with
initial and repeat courses of cancer chemotherapy, including, but not
limited to, highly emetogenic
chemotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
One 300 mg / 0.5 mg capsule should be administered approximately one
hour prior to the start of each
chemotherapy cycle.
The recommended oral dexamethasone dose should be reduced by
approximately 50 % when co-
administered with netupitant/palonosetron capsules (see section 4.5
and clinical studies administration
schedule in section 5.1).
Special populations
_Elderly people_
No dosage adjustment is necessary for elderly patients.
Caution should be exercised when using this
medicinal product in patients over 75 years, due to the long half-life
of the active substances and the
limited experience in this population.
_ _
_ _
_ _
2
_ _
_Renal impairment _
Dosage adjustment is not considered necessary in patients with mild to
severe renal impairment. Renal
excretion for netupitant is negligible. Mild to moderate renal
impairment does not significantly affect
palonosetron pharmacokinetic parameters. Total systemic exposure to
intravenous palonosetron
increased by approximately 28% in severe renal impairment relative to
healthy subjects. The
pharmacokinetics of palonosetron or netupitant has not been studied in
subjects with end-stage renal
disease requiring hemodialysi