Klacid 250mg/5ml granules for oral suspension

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ダウンロード 製品の特徴 (SPC)
15-10-2016

有効成分:

clarithromycin

から入手可能:

AbbVie S.r.l.

ATCコード:

J01FA09

INN(国際名):

clarithromycin

投薬量:

250mg/5ml

医薬品形態:

granules for oral suspension

パッケージ内のユニット:

plastic container 100ml and measuring syringe or measuring spoon

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2015-07-03

製品の特徴

                                SUMMARY OF PRODUCT CHARACTERISTICS
CLARITHROMYCIN
1. NAME OF THE MEDICINAL PRODUCT
KLACID
GRANULES FOR ORAL SUSPENSION
DOSAGE: 125 MG /5 ML, 250 MG/5 ML
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin 125 mg/5 ml, Granules for Oral Suspension (Pediatric
Suspension):
Each 5 ml of the granules for suspension contains 125 mg of
clarithromycin.
Clarithromycin 250 mg/5 ml, Granules for Oral Suspension (Pediatric
Suspension):
Each 5 ml of the granules for suspension contains 250 mg of
clarithromycin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clarithromycin Granules for Oral Suspension: White to off-white
granules for suspen-
sion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections caused by susceptible to clarithromycin
microorganisms:
• Upper respiratory tract infection (tonsillitis, pharyngitis,
sinusitis);
• Lower respiratory tract infections (bronchitis, pneumonia,
bacterial and atypical);
• Skin and soft tissue infections (impetigo, erysipelas,
follicular-lit, boils and infected
wounds);
• Disseminated mycobacterial infection caused by Mycobacterium avium
and Mycobac-
terium intracellulare;
• acute otitis media.
It is necessary to take into account official guidance on the
appropriate use of antibacte-
rial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Conducted clinical studies using clarithromycin pediatric suspension
involving children
aged 6 months to 12 years. Thus, you should use clarithromycin
pediatric suspension
(granules for suspension for internal use) for children under 12
years.
The recommended daily dose of clarithromycin granules for suspension
for internal use
(125 mg / 5 mL and 250 mg / 5 ml) in children is 7.5 mg / kg 2 times
per day to a max-
imum dose of 500 mg 2 times a day with non-mycobacterial infections.
The usual dura-
tion of treatment is 5-10 days depending on the pathogen and the
severity of the pa-
tient's condition. The finished slurry should be ingested without food
(milk can).
The table shows the dosing
                                
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