Macmiror tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nifuratel

Available from:

Doppel Farmaceutici S.r.l.

ATC code:

G01AX05

INN (International Name):

nifuratel

Dosage:

200mg

Pharmaceutical form:

tablets coated

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-31

Summary of Product characteristics

_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MACMIROR 200 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
active substance: nifuratel 200 mg
excipients with known effect: sucrose (each coated tablet contains 150
mg of sucrose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
Description of product: biconvex coated tablets, of bright white
color.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
vulvovaginal infections, which are caused by agents sensitive to this
medicinal product (pathogenic
microorganisms, Candida, Trichomonas, bacteria, chlamydia).
-
Pyelonephritis, urethritis, cystitis, pyelitis and other diseases of
the urinary tract.
-
intestinal amebiasis and lambliosis;
-
chronic inflammatory diseases of the upper GIT caused by Helicobacter
pylori.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Vulval-vaginal infections
_Adults _
One coated tablet to be taken by the woman and her partner 3 times a
day after the main meals, for 1 week.
Peroral treatment is combined with locally applied preparations such
as soft vaginal capsules or vaginal
cream.
In patients taking only peroral treatment in these indications the
daily dose needs to be increased up to 4 or
more coated tablets.
_Paediatric population _
The daily dose is 10 mg/kg of body mass for 10 days. The daily dose
should be divided to 2 partial doses.
Infections of urinary tract
_Adults _
For these diseases, the dose for adults is 1-2 coated tablets 3 times
a day after main meals for 1 – 2 weeks,
based on the type and nature of the infection.
Treatment can be prolonged or repeated without any risk upon a
doctor’s decision.
_Paediatric population _
The daily dose is 30 – 60 mg/kg of body mass- The daily dose should
be divided to 2 partial doses.
Intestinal amebiasis
_Adults _
2 coated tablets 2-3× a day for 10 days
_ _
2
_Paediatric population _
3x a day 10 mg /kg of body mass..
Intestinal giardiasis
_Adults _
2 coated tablets 2 �