Moxifloxacin 400 mg/250 ml Solution for Infusion, KabiPac bottles

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Moxifloxacin

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01MA; J01MA14

INN (International Name):

Moxifloxacin

Dosage:

400/250 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Fluoroquinolones; moxifloxacin

Authorization status:

Not marketed

Authorization date:

2014-01-17

Patient Information leaflet

1
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 _
_side effects_
).
2

If you were born with or have had any condition with abnormal heart
rhythm (se

Summary of Product characteristics

Health Products Regulatory Authority
04 March 2021
CRN00C3CS
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moxifloxacin 400 mg/250 ml 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 effect:
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 other antibacterial agents that are commonly
recommended for the 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).
There is insufficient data in patients with impaired liver function
(see section 4.3).
_Other special populations_
Health Products Regulatory Authority
04 March 2021
CRN00C3CS
Page 2 of 15
No adjustment of