MOXIVIG 0.5 %w/v Eye Drops Solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

MOXIFLOXACIN HYDROCHLORIDE

Prieinama:

Alcon Laboratories (UK) Ltd

ATC kodas:

S01AE07

INN (Tarptautinis Pavadinimas):

MOXIFLOXACIN HYDROCHLORIDE

Dozė:

0.5 %w/v

Vaisto forma:

Eye Drops Solution

Recepto tipas:

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

Gydymo sritis:

Fluoroquinolones

Autorizacija statusas:

Authorised

Leidimo data:

2009-07-31

Pakuotės lapelis

InDesign CS4
140 x 335  /  140 x 22 mm
AANTAL KLEUREN   :  
1
MM 
02-09- 2014
GBI
RECTO - verso
Moxivig 0.5  % 5 ml
64121 - 3 - DRAFT 
BELGIUM
V1
PMS ZWART
À 100  %  -  20  % 
64121 - 3
MOXIVIG
*
  0.5  % W / V EYE DROPS, SOLUTION
Moxifloxacin hydrochloride
PACKAGE LEAFLET  : INFORMATION FOR THE USER
MOXIVIG eye drops are used for the treatment of 
infections of the eye ( conjunctivitis ) when caused 
by bacteria. The active ingredient is moxifloxacin 
an ophthalmological anti-infective.
READ ALL OF THIS LEAFLET CAREFULLY 
BEFORE YOU START USING THIS MEDICINE 
BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your 
doctor or pharmacist.
• This medicine has been prescribed for you only. 
Do not pass it on to others. It may harm them, 
even if their symptoms are the same as yours.
• If you get any of the side effects talk to your 
doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. 
See section 4.
WHAT’S IN THIS LEAFLET  :
1.  What MOXIVIG is and what it is used for
2.  What you need to know before you use 
MOXIVIG
3.  How to use MOXIVIG
4.  Possible side effects
5.  How to store MOXIVIG
6.  Contents of the pack and other information
DO NOT USE MOXIVIG
• If you are allergic ( hypersensitive ) to 
moxifloxacin, to other quinolones, or any of the 
other ingredients of this medicine.
WARNINGS AND PRECAUTIONS
• IF YOU EXPERIENCE AN ALLERGIC REACTION 
TO MOXIVIG. Allergic reactions occur 
uncommonly and serious reactions occur 
rarely. If you experience any allergic 
( hypersensitivity ) reaction or any side effect 
please refer to section 4.
• IF YOU WEAR CONTACT LENSES – stop wearing 
your lenses if you have any signs or symptoms 
of an eye infection. Wear your glasses instead. 
Do not start wearing your lenses again until 
the signs and symptoms of the infec

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moxivig 0.5% w/v eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin (0.5% w/v).
Each eye drop contains 190 micrograms of moxifloxacin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, greenish
-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and
5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use only. Not for injection. MOXIVIG 0.5%w/v eye drops, solution should not be injected subconjunctivally
or introduced directly into the anterior chamber of the eye.
Use in adults including the elderly ( 65 years)
The dose is one drop in the affected eye(s) 3 times a day.
The infection normally improves within 5 days and treatment should then be continued for a further 2
-3 days. If no
improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered.
The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of
infection.
Paediatric patients
No dosage adjustment is necessary.
Use in hepatic and renal impairment
No dosage adjustment is necessary.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas
or other surfaces with the dropper tip of the bottle.
In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or