SUPRAX POWDER PAEDIATRIC 100 MG/5ml Powder for Oral Suspension

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

CEFIXIME

から入手可能:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATCコード:

J01DD08

INN（国際名）:

CEFIXIME

投薬量:

100 MG/5ml

医薬品形態:

Powder for Oral Suspension

処方タイプ:

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

治療領域:

Third-generation cephalosporins

認証ステータス:

Authorised

承認日:

1994-01-05

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprax 100mg/5ml Powder for Paediatric Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose of reconstituted suspension and each single dose sachet
contains 100 mg cefixime.
Excipients - contains sucrose 2.525g
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral suspension
When reconstituted with water gives a strawberry flavoured suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of infections due to micro-organisms
sensitive to the antibiotic including pathogens such as
_Streptococci pneumoniae and pyogenes_,_ E.coli_, Proteus,_ H.
influenza_ and_ B. catarrhalis_ (both beta lactamase positive
and negative), Klebsiella and Enterobacter species.
Most Enterococci, Staphylococci, Pseudomonas, Clostridia,_ Bacteroides
fragili_s and_ Listeria monoyctogenes_ are
resistant to Cefixime.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration is oral.
ADULTS AND CHILDREN OF 12 YEARS AND OVER (OR MORE THAN 50KG BODY
WEIGHT):
The usual daily dose is 200-400mg in single or twice daily dosage
regimen.
In uncomplicated upper respiratory tract infections or urinary tract
infections a daily dose of 200 mg may be sufficient.
CHILDREN AGED 9 TO 12 YEARS:
The usual total daily dose is 300mg (15ml of oral suspension) in
single or twice daily regimen.
CHILDREN AGED 5 TO 8 YEARS:
The usual total daily dose is 200 mg (10ml of oral suspension) in
single or twice daily dosage regimen.
CHILDREN AGED 2 TO 4 YEARS:
The usual total daily dose is 100 mg (5ml of oral suspension) in
single or twice daily dosage regimen.
CHILDREN AGED 6 MONTHS TO 2 YEARS:
The usual total daily dose in 8 mg/kg in single or twice daily
regimen.
The safety and efficacy of use in infants less than 6 months of age
has not been established.
ELDERLY:
The usual dosage is as for adults with appropriate modifications on
the basis of renal impairment.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H