Navoban

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Tropisetron hydrochloride 5.64mg equivalent to to 5 mg tropisetron

제공처:

Novartis New Zealand Ltd

INN (International Name):

Tropisetron hydrochloride 5.64 mg (equiv. to 5 mg tropisetron)

복용량:

5 mg

약제 형태:

Capsule

구성:

Active: Tropisetron hydrochloride 5.64mg equivalent to to 5 mg tropisetron Excipient: Colloidal silicon dioxide Gelatin Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Tekprint red SW-1102 Titanium dioxide

패키지 단위:

Blister pack, PVDC/PVC, 1 capsule

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Novartis Pharma AG

치료 징후:

The prevention of cancer-chemotherapy-induced nausea and vomiting.

제품 요약:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC - 1 capsules - 60 months from date of manufacture, no storage statement needed - Blister pack, PVDC/PVC - 2 capsules - 60 months from date of manufacture, no storage statement needed - Blister pack, PVDC/PVC - 3 capsules - 60 months from date of manufacture, no storage statement needed - Blister pack, PVDC/PVC - 5 capsules - 60 months from date of manufacture, no storage statement needed - Blister pack, PVDC/PVC - 50 capsules - 60 months from date of manufacture, no storage statement needed

승인 날짜:

1991-06-17

환자 정보 전단

__________________________________________________________________________________________________ 
NAVOBAN
®                                             

1 
NAVOBAN
®  
_5mg Capsule _
_2mg/2ml and 5mg/5ml Injection _
_tropisetron_ 
_____________________________________________________________________________________ 
CONSUMER MEDICINE INFORMATION 

__________________ 
WHAT IS IN THIS LEAFLET 
_________________________________ 

This leaflet answers some common 
questions about Navoban.  

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 it against the 
benefits they expect it will have for 
you. 

IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
________________________
WHAT NAVOBAN IS  
USED FOR 
________________________

Navoban 5 mg ampoules and 
capsules are used in the treatment of 
cancer to help prevent nausea 
(feeling sick) and vomiting caused by 
chemotherapy medicines. Navoban  
2 mg ampoules are used to treat 
nausea and vomiting which may 
happen after surgery. 

The active ingredient in Navoban is 
tropisetron. It works by stopping the 
action of a substance in the body 
called serotonin which is thought to 
bring about the nausea and vomiting. 

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY NAVOBAN HAS 
BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed this 
medicine for another reason.  

Navoban is only available with a 
doctor's prescription. It is not  
addictive.  
_____________________________ 
BEFORE YOU USE 
NAVOBAN 
______________________ 
_�

제품 특성 요약

DATA SHEET 

NAVOBAN
® 
TROPISETRON HYDROCHLORIDE 
5MG CAPSULE 
2MG/2ML AND 5MG/5ML INJECTION  

QUALITATIVE AND QUANTITATIVE COMPOSITION 
The active ingredient is ((1 alphaH, 5
alphaH)-8-Methyl-8-azabicyclo(3.2.1)oct-3-alphayl) 1H-
indole-3-carboxylate hydrochloride (= tropisetron hydrochloride). 
One capsule contains 5.64 mg tropisetron hydrochloride (= 5 mg
tropisetron base). 
One ampoule contains 2.26 mg tropisetron hydrochloride (= 2
mg tropisetron base) per 2 mL, 
or 5.64 mg tropisetron hydrochloride (= 5 mg tropisetron base) per 5
mL. 
For a full list of excipients, see List of excipients. 
PHARMACEUTICAL FORM 
Capsule: hard gelatine capsules for oral administration; 
Ampoule: glass ampoule containing an aqueous-solution for intravenous
administration. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
•  Prevention of cancer-chemotherapy-induced nausea and vomiting
(All dose forms). 
•  Treatment of post-operative nausea and vomiting (2mg/2ml
ampoule only). 
_DOSAGE AND METHOD OF ADMINISTRATION _
PREVENTION OF CANCER CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING 
ADULTS 
Navoban is recommended in adults as 6-day courses of 5 mg per day,
given intravenously on 
day 1 shortly before cancer chemotherapy either as an infusion
(diluted in a common infusion 
fluid such as normal saline, Ringer's solution, glucose 5%, or
levulose 5%) or as a slow 
injection (not less than 1 minute), followed by oral administration
on days 2 to 6. 
If tropisetron alone produces insufficient anti-emetic control, its
therapeutic efficacy can be 
enhanced by dexamethasone. 
Capsules should be taken with water in the morning immediately upon
rising, one hour before 
food intake. 

1
TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING 
ADULTS 
Navoban is recommended as a 2 mg dose given intravenously either as
an infusion (diluted in 
a common infusion fluid such as normal saline, Ringer's solution,
glucose 5% or levulose 
5%), or as a slow injection