Moxifloxacin Anfarm 400 mg/250 ml solution for infusion

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

MOXIFLOXACIN HYDROCHLORIDE

Pieejams no:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

ATĶ kods:

J01MA14

SNN (starptautisko nepatentēto nosaukumu):

MOXIFLOXACIN HYDROCHLORIDE 400/250 mg/ml

Zāļu forma:

SOLUTION FOR INFUSION

Kompozīcija:

MOXIFLOXACIN HYDROCHLORIDE 400/250 mg/ml

Receptes veids:

POM

Ārstniecības joma:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizācija statuss:

Authorised

Autorizācija datums:

2019-04-26

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MOXIFLOXACIN ANFARM 400MG/250ML SOLUTION FOR INFUSION
For use in adults
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, pharmacist or
nurse.
-If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Moxifloxacin Anfarm is and what it is used for
2. What you need to know before you Moxifloxacin Anfarm is given to
you
3. How to use Moxifloxacin Anfarm
4. Possible side effects
5. How to store Moxifloxacin Anfarm
6. Contents of the pack and other information
1. WHAT MOXIFLOXACIN ANFARM IS AND WHAT IT IS USED FOR
Moxifloxacin Anfarm contains the active substance moxifloxacin, which
belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin Anfarm works by
killing bacteria that cause
infections if they are caused by bacteria that are susceptible to
moxifloxacin.
Moxifloxacin Anfarm 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
2. WHAT YOU NEED TO KNOW BEFORE MOXIFLOXACIN ANFARM IS GIVEN TO YOU
Contact your doctor if you are not sure if you belong to a patient
group described below.
DO NOT USE MOXIFLOXACIN ANFARM
- If you are allergic to the active substance 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_
).
- If you were born with or have had any condition with abnormal heart

Produkta apraksts

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Moxifloxacin Anfarm 400 mg/250 ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle of 250 ml contains 400 mg moxifloxacin (as
hydrochloride). 1 ml contains 1.6 mg moxifloxacin (as
hydrochloride).
Excipient with known effect: 250 ml of solution for infusion contains
1.072mg (46.6 mmol)
sodium. For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, greenish-yellow solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moxifloxacin Anfarm 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).
There is insufficient data in patients with impaired liver function
(see section 4.3).
_ _
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_ Other special populations _
No adjustment of dosage is required in the elderly and in patients
with low bodyweight.
_Paediatric population _
Moxifloxacin is contraindicated in children and growing adolescents.
Efficac