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

Front page before folding
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 ARE ADMINISTERED 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 quinolone
antibiotics or any of the other ingredients  
  of this medicine (listed in section 6).
•  If you are pregnant or breast-feeding.
•  If you are under 18 years of age.
•  If you have a history of tendon disease or disorder which was
related to treatment with  
  quinolone antibiotics (see sections _Warnings and
precautions _and _4. Possible

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moxifloxacin 400mg/250ml Solution for Infusion, FreeFlex bags
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag 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).
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___