ALOXI® Solution for Injection 50mcgml

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Palonosetron Hydrochloride 0.28 mg/5ml eqv Palonosetron

Commercializzato da:

JUNIPER HEALTHCARE PTE LTD

Codice ATC:

A04AA05

Dosaggio:

50mcg/ml

Forma farmaceutica:

INJECTION, SOLUTION

Composizione:

Palonosetron Hydrochloride 0.28 mg/5ml eqv Palonosetron 50mcg/ml

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

FAREVA PAU 1

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2011-10-24

Foglio illustrativo

158244/0201203598.indd 1
158244/0201203598.indd 1
27/01/2022 14:51
27/01/2022 14:51
Tracy
Helsinn Birex
HBP
Font Size:
ESSENTRA PACKAGING IRELAND,
Supplied File
0201203598
2440
153
SGP Juniper Aloxi PONV PIL
Black
00158244
21003395
27/01/2022
1
3
410mm x 355mm
N/A
00158244 0201203598
158244/0201203598.indd 2
158244/0201203598.indd 2
27/01/2022 14:51
27/01/2022 14:51
Tracy
Helsinn Birex
HBP
Font Size:
ESSENTRA PACKAGING IRELAND,
Supplied File
0201203598
2440
153
SGP Juniper Aloxi PONV PIL
Black
00158244
21003395
27/01/2022
1
3
410mm x 355mm
N/A
31-01-2022

Scheda tecnica

_ALOXI_
®
SOLUTION FOR INJECTION 50 MCG/ML
INDICATIONS AND USAGE
CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING IN ADULTS
_ALOXI_
®
is indicated for:
•
Moderately emetogenic cancer chemotherapy -- prevention of acute and
delayed nausea and vomiting associated with initial and
repeat courses
•
Highly emetogenic cancer chemotherapy -- prevention of acute nausea
and vomiting associated with initial and repeat courses
CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING IN PEDIATRIC PATIENTS AGED 1
MONTH TO LESS THAN 17 YEARS
_ALOXI_
_®_
_ _
is indicated for:
•
Prevention of acute nausea and vomiting associated with initial and
repeat courses of moderately or highly emetogenic cancer
chemotherapy
POSTOPERATIVE NAUSEA AND VOMITING IN ADULTS
_ALOXI_
®
is indicated for:
•
Prevention of postoperative nausea and vomiting (PONV) for up to 24
hours following surgery. Efficacy beyond 24 hours has not
been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in
patients in whom there is little expectation that nausea and/or
vomiting will
occur postoperatively. In patients where nausea and vomiting must be
avoided during the postoperative period,
_ALOXI_
®
is recommended even
where the incidence of postoperative nausea and/or vomiting is low.
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSING
Chemotherapy-Induced Nausea and Vomiting
Age
Dose*
Infusion Time
Adults
0.25 MG
x 1
Infuse over
30
SECONDS
beginning
approx. 30 min before
the start of chemo
Pediatrics
(1 month to less
than 17 years)
20 MICROGRAMS PER
KILOGRAM
(max 1.5
mg) x 1
Infuse over
15
MINUTES
beginning
approx. 30 min before
the start of chemo
*Note different dosing units in pediatrics
The safety and efficacy of Aloxi in children aged less than 1 month
have not been established. No data are available. There is limited
data on the
use of Aloxi in the prevention of nausea and vomiting in children
under 2 years of age.
Postoperative Nausea and Vomiting
Dosage for Adults - a single 0.075 mg I.V. dose administered over 10
seconds immediately before the i