Airtal powder for oral suspension

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

aceclofenac

Tersedia dari:

Gedeon Richter PLC

Kode ATC:

M01AB16

INN (Nama Internasional):

aceclofenac

Dosis:

100mg

Bentuk farmasi:

powder for oral suspension

Unit dalam paket:

(20) sachets 3g

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-03-01

Karakteristik produk

1.
NAME OF THE MEDICINAL PRODUCT
AIRTAL 100 MG POWDER FOR ORAL SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 100 mg aceclofenac.
Excipients with known effect: contains 2.639 mg sorbitol (E420) and 10
mg aspartame (E951) in each
sachet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
Approximately 3 g white or almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in osteoarthritis,
rheumatoid arthritis and ankylosing
spondylitis as well as other painful locomotor disorders (e.g.
humeroscapular periarthritis and other
extra-articular rheumatism). Analgesic in different painful conditions
(including lumbar or dental pain
and primary dysmenorrhoea).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Adults_
The recommended dose is one sachet twice daily (one in the morning and
one in the evening).
_Paediatric population _
The safety and efficacy in children and adolescents have not been
established. The use of Airtal is not
recommended in paediatric population.
_Elderly_
The elderly, who are more likely to be suffering from impaired renal,
cardiovascular or hepatic
function and receiving concomitant medication, are at increased risk
of the serious consequences of
adverse reactions. If an NSAID is considered necessary, the lowest
effective dose should be used and
for the shortest possible duration. The patient should be monitored
regularly for GI bleeding during
NSAID therapy.
The pharmacokinetics of aceclofenac is not altered in elderly
patients. Generally no dose reduction is
necessary; however, consider the precautions in section 4.4.
_Hepatic insufficiency _
The dose of aceclofenac should be reduced in patients with mild to
moderate hepatic impairment. The
recommended initial dose is 100 mg daily.
2
_Renal insufficiency _