Clarem 500 tablets film-coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

clarithromycin

Dostopno od:

Remedica Ltd

Koda artikla:

J01FA09

INN (mednarodno ime):

clarithromycin

Odmerek:

500mg

Farmacevtska oblika:

tablets film-coated

Enote v paketu:

(14/2x7/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2016-07-27

Lastnosti izdelka

CLAREM 500 FC TABS-SPC-V1-03
1 of 8
Ref: CLAREM 500 FC TABS-SPC-V1-03
SUMMARY OF PRODUCT CHARACTERISTICS
_1. NAME OF THE MEDICINAL PRODUCT _
Clarem 500 Tablets
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Each Clarem 500 tablet contains 500mg Clarithromycin.
For full list of excipients refer to point 6.1.
_3. PHARMACEUTICAL FORM _
Film-Coated Tablets
_4. CLINICAL PARTICULARS _
_4.1. THERAPEUTIC INDICATIONS _
Clarem is indicated for treatment of infections caused by susceptible
organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia.
Upper respiratory tract infections for example, sinusitis and
pharyngitis.
Clarem is appropriate for initial therapy in community acquired
respiratory infections and has been
shown to be active in vitro against common and atypical respiratory
pathogens as listed in the
microbiology section.
Clarem is also indicated in skin and soft tissue infections of mild to
moderate severity.
Clarem in the presence of acid suppression effected by omeprazole or
lansoprazole is also indicated
for the eradication of _ H. pylori_ in patients with duodenal ulcers.
See Dosage and Administration
section.
Clarem is usually active against the following organisms _in vitro_:
Gram-positive Bacteria: _ Staphylococcus aureus_ (methicillin
susceptible); _ Streptococcus pyogenes_
(Group A beta-hemolytic streptococci), alpha-hemolytic streptococci
(viridans group_); Streptococcus _
_(Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria
monocytogenes_.
Gram-negative
Bacteria:
_Haemophilus _
_influenzae, _
_Haemophilus _
_parainfluenzae, _
_Moraxella _
_(Branhamella) _
_catarrhalis, _
_Neisseria _
_gonorrhoeae; _
_Legionella _
_pneumophila, _
_Bordetella _
_pertussis, _
_Helicobacter pylori; Campylobacter jejuni._
Mycoplasma: _Mycoplasma pneumoniae; Ureaplasma urealyticum._
Other
Organisms:
_Chlamydia _
_trachomatis; _
_Mycobacterium _
_avium; _
_Mycobacterium _
_leprae; _
_Mycobacterum _
_kansasii; _
_Mycobacterium _
_chelonae; _
_Mycobact