Aprepitant Accord 80 mg hard capsules

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Aprepitant

Доступна с:

Accord Healthcare Ireland Ltd.

код АТС:

A04AD12

ИНН (Международная Имя):

Aprepitant

дозировка:

80 milligram(s)

Фармацевтическая форма:

Capsule, hard

Терапевтические области:

aprepitant

Статус Авторизация:

Marketed

Дата Авторизация:

2019-03-22

тонкая брошюра

* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
FMD info
NA (not a carton)

No

Yes

Details
APREPITANT 80MG, 125MG & 125MG/80MG HARD CAPSULES PIL - UK/EIRE
Black
BBBA3644
S.Anson
19.12.18
21/12/18
R.Wrey
170 x 500
10pt
Pharmathen
19.12.18
20.12.18
5
Version 2
01.11.2017
_Continued top of next column _
BBBA3644
APREPITANT 125MG HARD CAPSULES
APREPITANT 80MG HARD CAPSULES
APREPITANT 125MG/80MG HARD CAPSULES
aprepitant
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
IF YOU ARE THE PARENT OF A CHILD TAKING
APREPITANT HARD CAPSULES , PLEASE READ THIS
INFORMATION CAREFULLY.
• 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
or the child 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 or the child gets any side effects, talk
to your doctor, pharmacist or nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
• The full name of this medicine is Aprepitant
Hard Capsules but within this leaflet it will
be referred to as Aprepitant Capsules.
WHAT IS IN THIS LEAFLET
1
WHAT APREPITANT CAPSULES ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE OR GIVE APREPITANT CAPSULES
3
HOW TO TAKE APREPITANT CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE APREPITANT CAPSULES
6
CONTENTS OF THE PACK AND OTHER
INFORMA

Характеристики продукта

Health Products Regulatory Authority
06 November 2023
CRN00DH0D
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aprepitant Accord 80 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg capsule contains 80 mg of aprepitant.
Excipient with known effect
Each 80 mg capsule contains 80 mg of sucrose and 0.00022 mmol (0.005
mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule)
The 80 mg hard capsules are presented as opaque hard gelatin capsules
of size No 2, with a white cap and white body,
imprinted in black ink with "80mg" on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of nausea and vomiting associated with highly and
moderately emetogenic cancer chemotherapy in adults and
adolescents from the age of 12.
Aprepitant 125 mg/80 mg capsules are given as part of combination
therapy (see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Aprepitant capsules are given for 3 days as part of a regimen that
includes a corticosteroid and a 5-HT
3
antagonist.
The recommended dose is 125 mg orally once daily one hour before start
of chemotherapy on Day 1 and 80 mg orally once
daily on Days 2 and 3 in the morning.
The following regimens are recommended in adults for the prevention of
nausea and vomiting associated with emetogenic
cancer chemotherapy:
_Highly Emetogenic Chemotherapy Regimen_
Day 1
Day 2
Day 3
Day 4
Aprepitant capsules
125 mg orally
80 mg orally
80 mg orally
none
Dexamethasone
12 mg orally
8 mg orally
8 mg orally
8 mg orally
5-HT
3
antagonists
Standard dose of
5-HT
3
antagonists.
See the product
information for the
selected 5-HT
3
antagonist for
appropriate dosing
information
none
none
none
DEXAMETHASONE should be administered 30 minutes prior to chemotherapy
treatment on Day 1 and in the morning on Days 2
to 4. The dose of dexamethasone accounts for active substance
interactions.
Health Products Regulatory Authority
06 November 2023
CRN00DH0D
Page 2 of 15
_Mo