Avelox 400 mg film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Moxifloxacin hydrochloride

Dostopno od:

PCO Manufacturing Ltd.

Koda artikla:

J01MA; J01MA14

INN (mednarodno ime):

Moxifloxacin hydrochloride

Odmerek:

400 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Fluoroquinolones; moxifloxacin

Status dovoljenje:

Authorised

Datum dovoljenje:

2009-07-24

Lastnosti izdelka

Health Products Regulatory Authority
09 April 2021
CRN00C8J3
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Portugal and Greece:_
Dull red film-coated tablet with an oblong, convex shape with facet,
and marked with "M400" on one side and "BAYER" on the
other side.
4 CLINICAL PARTICULARS
As per PA1410/027/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/027/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Film coat:
Hypromellose
Macrogol 4000
Iron oxide (E172)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market in
the country of origin.
Health Products Regulatory Authority
09 April 2021
CRN00C8J3
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cartons containing colourless or white opaque polypropylene/aluminium
blisters:
The film-coated tablets are available in packs of 5 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/230/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24th July 2009
10 DATE OF REVISION OF THE TEXT
April 2021