Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clarithromycin
Hankook Korus Pharm Co.
J01FA09
clarithromycin
500mg
tablets film-coated
(10/1x10/) in blister, (100/10x10/) in blister
Prescription
Registered
2020-12-30
Marketing Authorization Holder ASTERIA LLC, YEREVAN, REPUBLIC OF ARMENIA CLACIN-ASTERIA Tab. 500mg (Clarithromycin) To be prescribed ATC Code : J01FA09 CLACIN-ASTERIA Tab. 500mg 설명서(120*327) C-0 M-0 Y-0 K-100 [COMPOSITION] Each film coated tablet contains: Active ingredient Clarithromycin--------------------------------------------------------------------------------------------------------------------------- 500mg(potency) Excipients : Microcrystalline cellulose, Gelatinized starch, Povidone, Croscarmellose sodium, Colloidal Silicon Dioxide, Stearic Acid, Magnesium stearate, Talc, Hydroxypropyl methylcellulose 2910, Diacetylated Monoglycerides, Titanium oxide, Ethyl Vanillin, Sorbic acid, Yellow No. 5 [INDICATION] Lower respiratory tract Infection : Bronchitis, pneumonia Upper respiratory tract Infection : Pharryngitis, sinusitis Disseminates mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare H.pylori eradication to reduce the risk of duodenal ulcer recurrence [DOSAGE AND ADMINISTRATION] The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. _Children older than 12 years and adults:_ Standard dosage: The usual dose is 250 mg twice daily. High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. _Elimination of Helicobacter pylori in adults:_ In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin can be used in a dose of 500 mg twice daily during the eradication therapy in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily. _Dosage in renal functional impairment:_ The maximum recommended dosages should be reduced proportionately to renal impairment. At creatinine clearance rate of less than 30 ml/min, the dosage should be halved to 250 mg daily or in the most severe infections to 250 mg twice daily. The duration of treatment should not exceed 14 days in these pati read_full_document
Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTIC (SPC) CLACIN-ASTERIA TAB. 500MG (CLARITHROMYCIN) Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Clacin-Asteria Tab. 500mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient NO. CHEMICAL NAME QUANTITY/TAB. USE 1 Clarithromycin 500.0mg (potency) Active ingredient Excipient(s) NO. CHEMICAL NAME QUANTITY/TAB. USE 1 Microcrystalline cellulose 90.0mg Inactive 2 Gelatinized starch 75.0mg Inactive 3 Povidone 20.0mg Bonding agent 4 Croscarmellose sodium 40.0mg Disintegrant 5 Colloidal Silicon Dioxide 7.5mg Disintegrant 6 Stearic Acid 12.5mg Lubricant 7 Magnesium stearate 7.5mg Lubricant 8 Talc 17.5mg Lubricant 9 Hydroxypropyl methylcellulose 2910 24.0mg Coating agent 10 Diacetylated Monoglycerides 2.0mg Coating agent 11 Titanium oxide 4.0mg Coating agent 12 Ethyl Vanillin q.s flavoring agent 13 Sorbic acid 0.6mg Antioxidant 14 Yellow No. 5 q.s Coloring agent 3. PHARMACEUTICAL FORM Summary of Product Characteristics Film-coated Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lower respiratory tract Infection : Bronchitis, pneumonia Upper respiratory tract Infection : Pharryngitis, sinusitis Disseminates mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare H.pylori eradication to reduce the risk of duodenal ulcer recurrence 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. _Children older than 12 years and adults:_ Standard dosage: The usual dose is 250 mg twice daily. High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. _Elimination of Helicobacter pylori in adults:_ In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin can be used in a dose of 500 mg twice daily during the eradication therapy in combination with amoxicillin 1000 mg twice daily and read_full_document