AVELOX SOLUTION FOR INFUSION 400 mg250 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MOXIFLOXACIN HCl EQV MOXIFLOXACIN

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

J01MA14

Dosage:

400 mg/250 ml

Pharmaceutical form:

INJECTION

Composition:

MOXIFLOXACIN HCl EQV MOXIFLOXACIN 400 mg/250 ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Bayer AG

Authorization status:

ACTIVE

Authorization date:

2002-05-31

Patient Information leaflet

AVELOX ® Prescription use only
1. NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle or bag contains 250 mL solution for infusion containing 400
mg moxifloxacin (as hydrochloride)
3. PHARMACEUTICAL FORM
Solution for infusion
250 mL polyolefine flexible bag filled with minimum 250 mL clear,
yellow solution
250 mL glass bottle with clear, yellow solution filled with minimum
250 mL
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Avelox 400 mg solution for infusion is indicated for the treatment of
the following bacterial infection caused by susceptible strains: *
Community acquired pneumonia caused by _Streptococcus pneumoniae,
Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae
_or_ Moraxella catarrhalis_. *
Complicated skin and skin structure infections caused by
methicillin-susceptible _Staphylococcus aureus, Escherichia coli,
Klebsiella pneumoniae, _or_ Enterobacter cloacae._
For full list of susceptible strains, please refer to Pharmacodynamic
Properties.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Solution for Infusion:
The infusion solution should be infused intravenously over 60 minutes.
The solution for infusion can be administered directly or via a T-tube
together with compatible infusion solutions.
The following coinfusions were found to form stable mixtures over a
period of 24 hours at room temperature with Avelox infusion solution,
and can therefore be considered as compatible with Avelox solution for
infusion:
Water for Injections
Sodium Chloride 0.9%
Sodium Chloride 1 molar
Glucose 5%
Glucose 10%
Glucose 40%
Xylitol 20%
Ringer’s Solution
Lactated Ringer’s Solution
If Avelox infusion solution is to be given with another drug, each
drug should be given separately (see “Pharmaceutical Particulars,
Incompatibilities”).
Only clear solutions are to be used.
4.2.2 DOSAGE REGIMEN
DOSE (ADULTS):
The rec

Summary of Product characteristics

Avelox IV_CCDS 23_December 2020
PRESCRIPTION USE ONLY
1. NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle or bag contains 250 mL solution for infusion containing 400
mg moxifloxacin (as
hydrochloride)
3. PHARMACEUTICAL FORM
Solution for infusion
250 mL polyolefine flexible bag filled with minimum 250 mL clear,
yellow solution
250 mL glass bottle with clear, yellow solution filled with minimum
250 mL
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Avelox 400 mg solution for infusion is indicated for the treatment of
the following bacterial
infection caused by susceptible strains:
•
Community acquired pneumonia caused by _Streptococcus pneumoniae,
Haemophilus _
_influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae _or_
Moraxella catarrhalis_.
•
Complicated skin and skin structure infections caused by
methicillin-susceptible
_Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, _or_
Enterobacter _
_cloacae. _
For full list of susceptible strains, please refer to Pharmacodynamic
Properties.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
AVELOX® SOLUTION FOR INFUSION
Avelox IV_CCDS 23_December 2020
Solution for Infusion:
The infusion solution should be infused intravenously over 60 minutes.
The solution for infusion can be administered directly or via a T-tube
together with compatible
infusion solutions.
The following coinfusions were found to form stable mixtures over a
period of 24 hours at room
temperature with Avelox infusion solution, and can therefore be
considered as compatible with
Avelox solution for infusion:
Water for Injections
Sodium Chloride 0.9%
Sodium Chloride 1 molar
Glucose 5%
Glucose 10%
Glucose 40%
Xylitol 20%
Ringer’s Solution
Lactated Ringer’s Solution
If Avelox infusion solution is to be given with another drug, each
drug should be given
separately (see “Pharmaceutical Particulars, Incompa