MOXIFLOXACIN 400/250 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOXIFLOXACIN HCI, ANHYDROUS

Available from:

Fresenius Kabi Limited

ATC code:

J01MA14

INN (International Name):

MOXIFLOXACIN HCI, ANHYDROUS

Dosage:

400/250 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Fluoroquinolones

Authorization status:

Authorised

Authorization date:

2014-01-17

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOXIFLOXACIN 400 MG/250 ML 
SOLUTION FOR INFUSION
Moxifloxacin
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. 
-  If  you  get  any  side  effects,  talk  to  your 
doctor  or  pharmacist.  This  includes  any 
possible side effects not listed in this leaflet.
  See section 4.
WHAT IS IN THIS LEAFLET
1.  What Moxifloxacin is and what it is used for 
2.  What  you  need  to  know  before  you    use 
Moxifloxacin
3.  How to use Moxifloxacin
4.  Possible side effects
5.  How to store Moxifloxacin
6.  Contents of the pack and other information 
1.  WHAT MOXIFLOXACIN IS AND WHAT IT IS USED 
FOR
Moxifloxacin  contains  the  active  substance 
moxifloxacin  which  belongs  to  a  group  of 
antibiotics  called  fluoroquinolones.  Moxifloxacin 
works  by  killing  bacteria  that  cause  infections  if 
they are caused by bacteria that are susceptible 
(sensitive) to moxifloxacin.
Moxifloxacin  is  used  in  adults  for  treating  the 
following bacterial infections:
- 
Infection  of  the  lungs  (pneumonia)  acquired 
outside the hospital
- 
Infections of the skin and soft tissue
Moxifloxacin  is  only  used  to  treat  these 
infections when usual antibiotics cannot be used 
or have not worked.
2.  WHAT YOU  NEED TO  KNOW BEFORE YOU  USE 
MOXIFLOXACIN
Contact  your  doctor  if  you  are  not  sure  if  you 
belong to a patient group described below.
DO NOT USE MOXIFLOXACIN
•  If  you  are  allergic  to  moxifloxacin,  any  other 
qui

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moxifloxacin 400mg/250ml Solution for Infusion, KabiPac bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Each ml contains 1.6 mg moxifloxacin (as hydrochloride).
Excipient with known effects:
250 ml of solution for infusion contains 54.4 mmol sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear yellow solution.
pH of solution is between 5.0 and 6.0.
Osmolality of solution: 260 – 330 mOsm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moxifloxacin is indicated for the treatment of:
Community acquired pneumonia (CAP)
Complicated skin and skin structure infections (cSSSI)
Moxifloxacin should be used only when it is considered inappropriate
to use antibacterial agents that are commonly
recommended for the initial treatment of these infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 400 mg moxifloxacin, infused once daily.
Initial intravenous treatment may be followed by oral treatment with
moxifloxacin 400 mg tablets, when clinically
indicated.
In clinical studies most patients switched to oral therapy within 4
days (CAP) or 6 days (cSSSI). The recommended
total duration of intravenous and oral treatment is 7 - 14 days for
CAP and 7 - 21 days for cSSSI.
Renal/hepatic impairment
No adjustment of dosage is required in patients with mild to severely
impaired renal function or in patients on chronic
dialysis i.e. haemodialysis and continuous ambulatory peritoneal
dialysis (see section 5.2 for more details).
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