ALRINAST Film Coated Tablet 5

Land: Tansanía

Tungumál: enska

Heimild: Tanzania Medicinces & Medical Devices Authority

Virkt innihaldsefni:

Desloratadine

Fáanlegur frá:

ILKO ILAC SAN VE TIC. A.S., TURKEY

ATC númer:

Corticosteroids/ plain

INN (Alþjóðlegt nafn):

Desloratadine

Skammtar:

5

Lyfjaform:

Film Coated Tablet

Framleitt af:

ILKO ILAC SANAYI VE TICARET, TURKEY

Vörulýsing:

Physical description: Light blue colored, round shaped film coated tablets; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)

Leyfisstaða:

Registered/Compliant

Leyfisdagur:

2020-12-24

Vara einkenni

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ALRINAST 5 mg film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Desloratadine .............................. 5 mg
EXCIPIENT(S):
Lactose monohydrate ............. 2.8 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet
ALRINAST film coated tablet is light blue coloured, round shaped
tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ALRINAST is indicated for the relief of symptoms related with allergic
rhinitis such as
sneezing, runny nose and itching, congestion / stuffiness but also in
the eyes itching, tearing
and redness, in the palate itching and coughing.
ALRINAST is also indicated for the elimination of symptoms such as
ridges and redness of
the skin, relief of itching associated with urticaria.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY/ADMINISTRATION FREQUENCY AND DURATION:
Adults and adolescents (12 years of age and over):
The recommended dose is one tablet once a day.
Intermittent allergic rhinitis with presence of symptoms for 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
should
be
suspended
in
the
event
of
removal
and
recurrence
of
symptoms.
In persistent allergic rhinitis with presence of symptoms for 4 days
or more per week and for
more than 4 weeks, continuous treatment should be recommended in the
event of the
emergence of the patient's allergies.
_Paediatric population _
There is limited clinical trial efficacy experience with the use of
desloratadine in adolescent
s 12 through 17 years of age (see sections 4.8 and 5.1).
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The safety and efficacy of desloratadine 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.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS:
HEPATIC IMPAIRMENT:
There is no data on the us