Palonosetron beta 250 Mikrogramm Injektionslösung

Nchi: Ujerumani

Lugha: Kijerumani

Chanzo: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Viambatanisho vya kazi:

Palonosetronhydrochlorid

Inapatikana kutoka:

betapharm Arzneimittel GmbH (3364323)

ATC kanuni:

A04AA05

INN (Jina la Kimataifa):

Palonosetron hydrochloride

Dawa fomu:

Injektionslösung

Tungo:

Teil 1 - Injektionslösung; Palonosetronhydrochlorid (31115) 0,28 Milligramm

Njia ya uendeshaji:

intravenöse Anwendung

Idhini hali ya:

verlängert

Idhini ya tarehe:

2017-01-11

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 250 MICROGRAMS SOLUTION FOR
INJECTION
Palonosetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [invented name] is and what it is used for
2.
What you need to know before you use [invented name]
3.
How to use [invented name]
4.
Possible side effects
5.
How to store [invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name]
contains the active substance palonosetron. This belongs to a group of
medicines called
‘serotonin (5HT
3
) antagonists’.
[Invented name] is used in adults, adolescents and children over one
month of age to help stop you
feeling or being sick (nausea and vomiting) when having cancer
treatments called chemotherapy.
It works by blocking the action of a chemical called serotonin, which
can cause you to feel sick or
to vomit.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [INVENTED NAME]
DO NOT USE [INVENTED NAME] IF:
-
you are allergic to palonosetron or any of the other ingredients of
this medicine (listed in
section 6).
You will not be given [invented name] if any of the above apply to
you. If you are not sure, talk to your
doctor, pharmacist or nurse before you are given this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using [invented name]
if:
-
you have a blocked bowel or have had repeated constipation in the
past.
-
you have had heart problems or heart problems run in your family, such
as change

Tabia za bidhaa

2
1.
NAME OF THE MEDICINAL PRODUCT
[Invented name] 250 micrograms solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride).
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
pH value: between 4.5 and 5.5
Osmolality: between 270 to 310 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palonosetron is indicated in adults for:
•
the prevention of acute nausea and vomiting associated with highly
emetogenic cancer
chemotherapy,
•
the prevention of nausea and vomiting associated with moderately
emetogenic cancer
chemotherapy.
Palonosetron is indicated in paediatric patients 1 month of age and
older for:
•
the prevention of acute nausea and vomiting associated with highly
emetogenic cancer
chemotherapy and prevention of nausea and vomiting associated with
moderately emetogenic
cancer chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Palonosetron should be used only before chemotherapy administration.
This medicinal product
should be administered by a healthcare professional under appropriate
medical supervision.
Posology
_Adults_
250 micrograms palonosetron administered as a single intravenous bolus
approximately 30 minutes
before the start of chemotherapy. [invented name] should be injected
over 30 seconds.
The efficacy of palonosetron in the prevention of nausea and vomiting
induced by highly
emetogenic chemotherapy may be enhanced by the addition of a
corticosteroid administered
prior to chemotherapy.
_Elderly people_
No dose adjustment is necessary for the elderly.
3
_Paediatric population _
_Children and Adolescents (aged 1 month to 17 years):_
20 micrograms/kg (the maximum total dose should not exceed 1500
micrograms) palonosetron
administered as a single 15 minute intravenous infusion beginning
approximately 30 minutes before
the start of chemoth