PHARMALENE B

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Karakteristik produk Karakteristik produk (SPC)
01-01-2020

Bahan aktif:

ADAPALENE, BENZOYL PEROXIDE

Tersedia dari:

GENERO PHARMACEUTICALS - Indonesia

INN (Nama Internasional):

ADAPALENE, BENZOYL PEROXIDE

Dosis:

1 MG /25 MG

Bentuk farmasi:

GEL

Unit dalam paket:

DUS, 1 TUBE PLASTIK @ 10 G

Diproduksi oleh:

GENERO PHARMACEUTICALS - Indonesia

Tanggal Otorisasi:

2020-09-26

Karakteristik produk

                                Bahasa Inggris
PHARMALENE B
Adapalene
Benzoyl Peroxide
Gel
Composition :
Each gram of gel contains :
Adapalene
.............................................................................................................
1 mg
Benzoyl Peroxide
.................................................................................................
25 mg
Mechanism of action:
Adapalene acts on retinoid receptors. Mechanistically, Adapalene binds
to specific Retinoic acid
nuclear receptors but it does not bind to the cytosolic receptor
protein. Although the exact mode of
action of Adapalene is unknown, it is suggested that topical Adapalene
normalizes the differentiation
of follicular epithelial cells resulting in decreased microcomedone
formation.
Benzoyl Peroxide is an antibacterial agent which is believed to act by
oxidizing proteins, including
bacterial proteins, and reducing the population of Propionibacterium
acnes which are usually
abnormally present in the acne-affected pilosebaceous unit. Therefore,
Adapalene and Benzoyl
Peroxide act through different, but complementary, mechanisms that
affect different aspects of
acne therapy.
Indication :
Pharmalene B is indicated for the topical treatment of acne vulgaris
in patients 12 years of age and
older.
Dosage and administrations :
Apply a thin film of Pharmalene B to affected areas of the face and/or
trunk once daily after washing
with a mild or soapless cleanser. Use a pea-sized amount for each area
of the face (e.g., forehead,
chin, each cheek).
Avoid the eyes, lips and mucous membranes. Pharmalene B is not for
oral, opthalmic, or intravaginal
use.
•The product can be used within 60 days after opened.
DISETUJUI OLEH BPOM: 23/01/2020
ID: EREG10023811800025
Contraindication :
Patients with history of hypersensitivity to Adapalene, Benzoyl
Peroxide or to any other component
of this preparation.
Adverse Reactions :
If skin irritation appears after application of Pharmalene B, the
intensity is generally mild or
moderate, with local tolerability signs and symptoms [erythema
                                
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