Aprepitant 80mg capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Aprepitant

Tillgänglig från:

Zentiva Pharma UK Ltd

ATC-kod:

A04AD12

INN (International namn):

Aprepitant

Dos:

80mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04060000; GTIN: 8594739231665

Bipacksedel

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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
Page 3 of 3
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

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aprepitant Zentiva 80mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg capsule contains 80mg of aprepitant.
Excipient with known effect
Each 80mg 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 80mg 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
on Day 1 and in the morning on Day 2 to 4. The dose of dexamethasone
accounts for
active substance interactions.
_Moderately Emetogenic Chemotherapy Regimen _
Day 1
Day 2
Day 3
Aprepitant
125mg orally
80mg orally
80mg orally
Dexamethasone
12mg orally
None
None
5-HT
3
antagonists
Standard dose of
5-HT
3
antagon