Moxiclav BIS 457mg/5ml Powder for Oral Suspension

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

AMOXICILLIN, CLAVULANIC ACID

から入手可能:

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

ATCコード:

J01CR02

INN（国際名）:

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

医薬品形態:

POWDER FOR ORAL SUSPENSION

構図:

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

処方タイプ:

POM

治療領域:

ANTIBACTERIALS FOR SYSTEMIC USE

認証ステータス:

Authorised

承認日:

2015-09-02

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOXICLAV BIS 457MG/5ML POWDER FOR ORAL SUSPENSION
Amoxicillin/ clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR THEM.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for your baby or child only. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as your
child’s.
-
If your child gets any side effects, talk to your doctor or pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Moxiclav Bis is and what it is used for
2.
What you need to know before you give Moxiclav Bis
3.
How to use Moxiclav Bis
4.
Possible side effects
5.
How to store Moxiclav Bis
6.
Contents of the pack and other information
1.
WHAT MOXICLAV BIS IS AND WHAT IT IS USED FOR
Moxiclav Bis 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 Bis is used in babies and children to treat the following
infections:
•
middle ear and sinus infections
•
respiratory tract infections
•
urinary tract infections
•
skin and soft tissue infections including dental infections
•
bone and joint infections.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOXICLAV BIS
_ _
DO NOT GIVE YOUR CHILD MOXICLAV BIS:
•
if they are allergic to amoxicillin, clavulanic acid or any of the
other ingredients of Moxiclav Bis
(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 swelling of the face or neck.
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製品の特徴

spc-coamoxbis-pfos-1.4-MT
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MOXICLAV BIS 457mg/5ml powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Moxiclav Bis contains 400 mg amoxicillin and 57 mg clavulanic acid per
5ml (co-amoxiclav
400/57).
Amoxicillin is present as amoxicillin trihydrate and clavulanic acid
is present as potassium
clavulanate.
Excipient with known effect: sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white free flowing powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moxiclav Bis is 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)
• 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.
spc-coamoxbis-pfos-1.4-MT
Page 2 of 22
• 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 Bis that is 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 alternative presentations of Moxiclav (e.g. those that
provide higher doses of amoxicillin
and/or different ratios of amoxicillin to clavulanic acid) should be
considered as necessary (see
sections 4.4 and 5.1).
For children < 40 kg, th