ALOXI palonosetron (as hydrochloride) 250 micrograms/5mL solution for injection vial

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

palonosetron hydrochloride, Quantity: 56 microgram/mL (Equivalent: palonosetron, Qty 50 microgram/mL)

Disponibil de la:

Juniper Biologics Pty Ltd

INN (nume internaţional):

Palonosetron hydrochloride

Forma farmaceutică:

Injection, solution

Compoziție:

Excipient Ingredients: sodium hydroxide; disodium edetate; hydrochloric acid; sodium citrate dihydrate; mannitol; water for injections; citric acid monohydrate

Calea de administrare:

Intravenous

Unități în pachet:

5mL vial (pack of 1 vial)

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

ALOXI is indicated for: - prevention of nausea and vomiting induced by cytotoxic chemotherapy. - prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

Rezumat produs:

Visual Identification: Clear, essentially colourless solution free from evidence of contamination.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2006-06-26

Prospect

ALOXI
®
1
ALOXI
®
_Palonosetron 250 microgram per 5 mL solution for injection;
Palonosetron 75 microgram per 1.5 mL _
_solution for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALOXI. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ALOXI IS USED
FOR
This medicine belongs to a group of
medicines known as serotonin (5-
HT3) antagonists and is a colourless
solution for injection into a vein.
It is used for the prevention of nausea
and vomiting that happens:
•
with cancer chemotherapy
•
up to 24 hours while recovering
from anaesthesia after surgery.
Your doctor, however, may prescribe
this medicine for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
ALOXI
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO PALONOSETRON OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching, hives or flushed, red
skin
ALOXI should not be used to prevent
or treat nausea and vomiting in the
days following chemotherapy if not
associated with another
chemotherapy administration.
_BEFORE YOU ARE GIVEN IT _
Your doctor must know about all of
the following before you are given
this medicine.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ALLERGIES TO:
•
ANY MEDICINES, IN PARTICULAR IF
YOU HAVE HAD AN ALLERGIC
REACTION TO ANOTHER MEDICINE
FOR NAUSEA OR VOMITI

Caracteristicilor produsului

ALOXI
®
SOLUTION FOR INJECTION
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION – ALOXI
® [PALONOSETRON (AS
HYDROCHLORIDE)] SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Palonosetron hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALOXI injection is a sterile, clear, colourless, non-pyrogenic,
isotonic, buffered solution for
intravenous administration.
ALOXI injection is available as 5 mL single use vial or 1.5 mL single
use vial.
Each 5 mL vial of ALOXI injection contains 250 microgram equivalent
palonosetron base
as hydrochloride. Each 1.5 mL vial contains 75 microgram equivalent
palonosetron base as
hydrochloride.
The inactive ingredients in ALOXI injection are mannitol, disodium
edetate, citric acid
monohydrate, sodium citrate dihydrate, sodium hydroxide and/or
hydrochloric acid and water
for injections.
3
PHARMACEUTICAL FORM
ALOXI solution for injection is a clear, essentially colourless
solution in a clear glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ALOXI is indicated for:
•
prevention of nausea and vomiting induced by cytotoxic chemotherapy
•
prevention of postoperative nausea and vomiting (PONV) for up to 24
hours following
surgery.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE FOR ADULTS – CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)
The recommended dosage of ALOXI is 250 microgram administered as a
single dose
approximately 30 minutes before the start of chemotherapy.
Drug accumulation was observed in subjects administered ALOXI on
consecutive days or once
every two days for three doses (see Section 5.2 – Pharmacokinetic
properties). Safety and
efficacy data available regarding repeated dosing of ALOXI within a
course of multi-day
chemotherapy are limited (see Section 5.1 – Pharmacological
properties; Clinical Trials).
ALOXI
®
SOLUTION FOR INJECTION
Page 2 of 15
DOSAGE FOR ADULTS – POSTOPERATIVE NAUSEA AND VOMITING (PONV)
The recommended dosage of ALOXI is 75 microgram administered as single
dose immediately
before induction of anaesthesia.
USE IN GERIATRIC PA