Երկիր: Հայաստան
Լեզու: անգլերեն
Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
moxifloxacin
Bayer AG
J01MA14
moxifloxacin
400mg
tablets coated
(5/1x5/) in blister
Prescription
Registered
2019-03-20
1 RESTRICTED SUMMARY OF PRODUCT CHARACTERISTICS 2 RESTRICTED 1. NAME OF THE MEDICINAL PRODUCT Avelox 400 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: The coated tablet contains 68 mg lactose monohydrate (= 66.56 mg lactose) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet Dull red coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on one side and “BAYER” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Avelox 400 mg coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1). In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections: - Acute bacterial sinusitis - Acute exacerbation of chronic obstructive pulmonary disease including bronchitis In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed: - Community acquired pneumonia, except severe cases - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. Avelox 400 mg coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of _Neisseria _ _gonorrhoeae_ unless moxifloxacin-resistant _Neisseria gonorrhoeae_ can be excluded (see sections 4.4 and 5.1). Կարդացեք ամբողջական փաստաթուղթը