Moxiclav 156.25mg/5ml powder for oral suspension

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

AMOXICILLIN, CLAVULANIC ACID

থেকে পাওয়া:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

এটিসি কোড:

J01CR02

INN (আন্তর্জাতিক নাম):

CLAVULANIC ACID 31.25 mg/5ml AMOXICILLIN 125 mg/5ml

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR ORAL SUSPENSION

রচনা:

CLAVULANIC ACID 31.25 mg/5ml AMOXICILLIN 125 mg/5ml

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

ANTIBACTERIALS FOR SYSTEMIC USE

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2006-12-27

তথ্য লিফলেট

MoxiclavPIL.MT2.0
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOXICLAV 125 MG/31, 25 MG /5 ML POWDER FOR ORAL SUSPENSION
MOXICLAV FORTE 250 MG/62, 5 MG/5 ML POWDER FOR ORAL SUSPENSION
{Co-Amoxiclav}
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
•
This medicine is usually prescribed for a baby or child. Do not pass
it on to others. It may harm them,
even if their signs of illness are the same as your child.
•
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What
Moxiclav is and what it is used for
2.
What you need to know before you take Moxiclav
3.
How to take Moxiclav
4.
Possible side effects
5.
How to store Moxiclav
6.
Contents of the pack and other information
1.
WHAT MOXICLAV IS AND WHAT IT IS USED FOR
Moxiclav is an antibiotic and works by killing bacteria that cause
infections. It contains two different
medicines called amoxicillin and clavulanic
acid. Amoxicillin belongs to a group of medicines called
“penicillins” that can sometimes be stopped from working (made
inactive). The other active component
(clavulanic acid) stops this from happening.
Moxiclav is used in babies and children to treat the following
infections:
•
middle ear and sinus infections
•
respiratory tract infections
•
urinary tract infections
MoxiclavPIL.MT2.0
•
skin and soft tissue infections including dental infections
•
bone and joint infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOXICLAV
DO NOT GIVE YOUR CHILDEN MOXICLAV:
•
if they are allergic to amoxicillin/ clavulanic acid penicillin or any
of the other ingredients of this medicine
(listed in section 6).
•
if they have ever had a severe allergic (hypersensitive) reaction to
any other antibiotic. This can include a
skin rash or swel

পণ্য বৈশিষ্ট্য

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Moxiclav 156.25mg/5ml powder for oral suspension
Moxiclav Forte 312.50mg/5ml powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After
reconstitution
each
5ml
of
Moxiclav
contains
amoxicillin
trihydrate
equivalent
to
125mg
amoxicillin base and potassium clavulanate equivalent to 31.25mg
clavulanic acid.
After reconstitution each 5ml of Moxiclav Forte contains amoxicillin
trihydrate equivalent to 250mg
amoxicillin base and potassium clavulanate equivalent to 62.5mg
clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
125 mg/31.25 mg/5 ml powder for oral suspensions
250 mg/62.5 mg/5 ml powder for oral suspensions
White to off white free flowing powder.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Moxiclav and Moxiclav Forte are indicated for the treatment of the
following infections in adults and
children (see sections 4.2, 4.4 and 5.1):
•
Acute bacterial sinusitis (adequately diagnosed)
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•
Acute otitis media
•
Acute exacerbations of chronic bronchitis (adequately diagnosed)
•
Community acquired pneumonia
•
Cystitis
•
Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis.
•
Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are
stated in terms of an individual component.
The dose of Moxiclav and Moxiclav Forte that are selected to treat an
individual infection should take
into account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient as shown below.
The use of alter