Moxiral tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

moxifloxacin (moxifloxacin hydrochloride)

Disponibil de la:

Alkaloid AD Skopje

Codul ATC:

J01MA14

INN (nume internaţional):

moxifloxacin (moxifloxacin hydrochloride)

Dozare:

400mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(5/1x5/) and (7/1x7/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-10-22

Caracteristicilor produsului

Moxiral
®
400 mg film-coated tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Moxiral
®
400 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 400 mg moxifloxacin (as
hydrochloride).
Excipient with known effect: color sunset yellow (E110).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Oblong, biconvex, pale orange film-coated tablets with break mark on
one side.
The break
mark is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moxiral is 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 (adequately diagnosed)
-
Acute exacerbations of chronic obstructive pulmonary disease including
bronchitis
(adequately diagnosed)
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.
Moxiral
®
400 mg film-coated tablets
Summary of Product Characteristics
2
Moxiral is 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
gonorrhoea