Aprepitant 125mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Aprepitant

Disponible depuis:

Sandoz Ltd

Code ATC:

A04AD12

DCI (Dénomination commune internationale):

Aprepitant

Dosage:

125mg

forme pharmaceutique:

Oral capsule

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04060000; GTIN: 07613421026493

Notice patient

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1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.ai
aprepitant
1 x 125 mg hard capsule
and
2 x 80mg hard capsules
Aprepitant Zentiva 125mg/80mg hard capsules
Aprepitant Zentiva 125mg/80mg hard capsules
Aprepitant Zentiva 125mg/80mg hard capsules
Aprepitant Zentiva 125mg/80mg hard capsules
1 x 125 mg hard capsule and 2 x 80 mg hard capsule
Aprepitant 125mg/80 mg hard capsules
Each 80 mg capsule contains 80 mg of aprepitant.
Each 125 mg capsule contains 125 mg of aprepitant.
Contains sucrose and sodium
Read the package leaflet before use.
Oral use.
Store in the original package
in order to protect
from moisture.
KEEP OUT OF
THE SIGHT
AND REACH
OF CHILDREN.
PL 17780/0824
Zentiva Pharma UK Limited
12 New Fetter Lane
London EC4A 1JP
United Kingdom
1065019079
*WILL BE IMPLEMENTED
NOT LATER THAN 2/2019
_Data matrix code_
_printed on the right _
_of the variable data _
_Tamper evidence sol._
Orders _with_
_serialization_
PC:
SN:
Batch No:
EXP:
Orders _without_
_serialization_
Batch No:
EXP:
aprepitant
#125 mg/#80 mg
1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.pdf 1 6/2/2020
1:37:37 PM
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1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.ai
PMS 287 C • PMS 7528 C • PMS 568 C • PMS 339 C • PMS 2727 C
KEYLINE • BRAILLE • VARNISH FREE
Correction to the Braille text.
Space is required bewteen the number and the units 'mg' in the braille
text.
This needs to be implemented in the next production run.
Correction to the Braille text.
Space is required bewteen the number and the units 'mg' in the braille
text.
This needs to be implemented in the next production run.
aprepitant
#125 mg/#80 mg
aprepitant
#125 mg/#80 mg
N/A
N/A
Helvetica Neue LT Std 7 pt
N/A
N/A
100 x 24 x 145 mm
Pharmaten
RV
02.06.2020
V1
718149
APREPITANT 80;125MG; CD WAL1X1+2
Box
1065019079
REEL POSITION
REEL POSITION
TECHNICAL COLOURS
TECHNICAL COLOURS
COLOURS [ 5 ]
COLOURS [ 5 ]
TECHNICAL INFO
TECHNICAL INFO
GENERAL INFO
GENERAL INFO
REASON FOR CHANGE
REASON FOR CHANGE
BRAILLE TEXT:
MATERIAL TYPE (TS):
LOOK CODE:
FONT + MI

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aprepitant Zentiva 125mg/80mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 125 mg capsule contains 125mg of aprepitant.
Each 80 mg capsule contains 80 mg of aprepitant.
Excipient with known effect
Each 125mg capsule contains 125 mg of sucrose and 0.00026 mmol (0.006
mg) of sodium.
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 125mg hard capsules are presented as opaque hard gelatin capsules
of size No 1,
with a pink cap and white body, imprinted in black ink with
“125mg” on the body.
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 125mg/80 mg is given as part of combination therapy (see
section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Aprepitant is given for 3 days as part of a regimen that includes a
corticosteroid and a
5-HT3 antagonist.
The recommended dose is 125mg 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
125mg
orally
80mg
orally
80mg
orally
none
Dexamethasone
12mg orally
8mg orally
8mg orally
8mg orally
5-HT
3
antagonists
Standard
dose of
5-HT
3
antagonists.
See the
product
information
for selected
5-HT
3
antagonist
for
appropriate
dosing
information
None
None
None
Dexamethasone should be administered 30 minutes prior to chemotherapy
treatment