Airtal cream

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Unduh Karakteristik produk (SPC)
01-03-2022

Bahan aktif:

aceclofenac

Tersedia dari:

Gedeon Richter PLC

Kode ATC:

M02AA25

INN (Nama Internasional):

aceclofenac

Dosis:

15mg/g

Bentuk farmasi:

cream

Unit dalam paket:

60g aluminium tube

Jenis Resep:

OTC

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-03-01

Karakteristik produk

                                1.
NAME OF THE MEDICINAL PRODUCT
AIRTAL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
15 mg aceclofenac in 1 g of cream.
Excipients with known effect:
0.20 g of methyl-parahydroxybenzoate (E218) in 100 g of cream,
0.05 g of propyl-parahydroxybenzoate (E216) in 100 g of cream,
cetyl-stearyl-alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of all types of local pain and inflammation of different
locomotor origin, including
traumatic injuries.
It can be used for the alleviation of inflammation of tendons,
ligaments, muscles and joints, in case of
sprain, overstrain, or contusion, as well as for the treatment of
lumbago, torticollis, and periarthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is for external use only and must not be used under
occlusive bandages.
Airtal cream should be applied three times daily, by gently massaging
into the affected area. The
applied dose depends on the size of affected area: 1.5-2 g of Airtal
cream (it is approximately a strip of
5-7 cm of cream).
There is no experience in the use of Airtal cream IN CHILDREN;
therefore, Airtal cream is
contraindicated in children.
No dosage adjustment is required in the elderly.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance (aceclofenac) or to any of
the excipients listed in
section 6.1.

It should not be given to patients who have shown hypersensitivity to
other NSAIDs. Even
though possible cross hypersensitivity with diclofenac has not been
established, application is
not recommended to those patients who have demonstrated
hypersensitivity to diclofenac.

As with other non-steroidal anti-inflammatory drugs, aceclofenac is
contraindicated in patients
in whom acetylsalicylic acid or other non-steroidal anti-inflammatory
drugs caused asthmatic
attacks, urticaria or acute rhinitis.

Childhood.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE

If the use of Airtal cream produces symptoms of loc
                                
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