Desa 5mg F.C tablets 5mg tablets film-coated

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

desloratadine

Հասանելի է:

Delta Pharma

ATC կոդը:

R06AX27

INN (Միջազգային անվանումը):

desloratadine

Դոզան:

5mg

Դեղագործական ձեւ:

tablets film-coated

Միավորները փաթեթում:

(20/2x10/) strips

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2015-02-20

Տեղեկատվական թերթիկ

INSERT LEAFLET
DESA 5 MG F.C TABLETS
(DESLORATADINE)
COMPOSITION:
_ACTIVE INGREDIENT: _each film coated tablet contains 5mg
desloratadine.
_INACTIVE INGREDIENTS: _Avicel PH102, Mg stearate, Croscarmllose
sodium, talc,
lactose monohydrate, povidone K30.
FILM COAT COMPOSITION:_ _ hydroxyl propyl methyl cellulose 2910,
titanium
dioxide, polyethylene glycol 6000, patent blue colour.
PHARMACEUTICAL FORM: Oral film coated tablets.
THERAPEUTIC INDICATIONS:
Desa is indicated in adults and adolescents aged 12 years and older
for the
relief of symptoms associated with:
•Allergic rhinitis.
•Urticaria.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_Adults and adolescents (12 years of age and over): _
The recommended dose of Desa is one tablet once a day. Intermittent
allergic
rhinitis (presence of symptoms for less than 4 days per week or for
less than 4
weeks) should be managed in accordance with the evaluation of
patient's
disease history and the treatment could be discontinued after symptoms
are
resolved and reinitiated upon their reappearance.In persistent
allergic rhinitis
(presence of symptoms for 4 days or more per week and for more than 4
weeks), continued treatment may be proposed to the patients during the
allergen exposure periods.
_Pediatric population _
There is limited clinical trial efficacy experience with the use of
desloratadine
in adolescents 12 through 17 years of age. The safety and efficacy of
Desa 5
mg film coated tablets in children below the age of 12 years have not
been
established. No data are available.
_METHOD OF ADMINISTRATION _
Oral use.
The dose can be taken with or without food.
CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients ,
or to
loratadine.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the case of severe renal insufficiency, Desa should be used with
caution.
Desa
film
coated
tablets
contain
lactose.
Patients
with
rare
hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-
galactose malabsorption should not take thi

Ապրանքի հատկությունները

THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Desa 5mg F.C tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each F.C tablet contains
*ACTIVE SUBSTANCE
Desloratadine
……..……………….……..……………………..………..5mg
*EXCIPIENTS
Avicel
pH102……………………………………..…….............................24mg
Lactose monohydrate
……………………………..…............................
61mg
Mg stearate
…………………………………….....................…………....0.5
mg
Crosscarmellose sodium
………………………....…………………… 5mg
Talc purified
…………………………………………………… 3.495mg
Povidone K
30…………………………………....................................…..
3 mg
*FILM COAT COMPOSITION:
Hydroxypropyl methylcellulose
2910...................................................................
2 mg
Titanium
dioxide..................................................................................................
0.5 mg
Polyethylene glycol
6000......................................................................................
0.5 mg
Patent blue
color..................................................................................................
0.005mg
3. PHARMACEUTICAL AND DOSAGE FORM
Film coated tablets
4. CLINICAL PARTICULAR
4.1 THERAPEUTIC INDICATIONS
Desa is indicated for the relief of symptoms associated with:
- Allergic rhinitis
- Urticaria
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents (12 years of age and over): one tablet once a
day, with or without a meal for the
relief of symptoms associated with allergic rhinitis (including
intermittent and persistent allergic
rhinitis) and urticaria.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to any of the excipients or
to loratadine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Efficacy and safety of Desloratadine tablets in children under 12
years of age have not been