AKLIEF CREAM 50mcgg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Trifarotene

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

D10AD06

Pharmaceutical form:

CREAM

Composition:

Trifarotene 50 mcg/g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

Laboratoires GALDERMA

Authorization status:

ACTIVE

Authorization date:

2022-08-17

Summary of Product characteristics

1
SINGAPORE PRODUCT INFORMATION
AKLIEF (TRIFAROTENE) CREAM
1
NAME OF THE MEDICINE
Aklief Cream 50mcg/g
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 50 micrograms of Trifarotene.
EXCIPIENTS WITH KNOWN EFFECT
Contains alcohol as 50 mg/g ethanol. For the full list of excipients
see section 6.1 LIST OF
EXCIPIENTS
3
PHARMACEUTICAL FORM
Cream
White and homogenous cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aklief is indicated for the topical treatment of _Acne Vulgaris_ of
the face and/or the trunk in
patients from 12 years of age and older, when many comedones, papules
and/or pustules are
present.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Apply a thin layer of Aklief cream to the affected areas of the face
and/or trunk once a day, in
the evening, on clean and dry skin.
It is recommended that the physician assesses the continued
improvement of the patient after
three months of treatment. The duration of treatment should be
determined by the doctor based
on the clinical response.
_Special populations_
_Elderly patients _
The safety and efficacy of Aklief in geriatric patients aged 65 years
and above have not been
established.
2
RENAL IMPAIRMENT AND HEPATIC IMPAIRMENT
Aklief has not been studied in patients with renal and hepatic
impairment.
_Paediatric population _
The safety and efficacy of Aklief in children below 12 years old have
not been established.
Method of administration
For topical use only.
Before using the pump for the first time, prime it by pressing down
several times until a small
amount of medicine is dispensed (up to 10 times maximum). The pump is
now ready to use.
Apply a thin layer of Aklief cream to the affected areas of the face
(forehead, nose, chin and
right and left cheeks) and all affected areas of the trunk once a day,
in the evening, on clean
and dry skin:
-
One pump actuation should be enough to cover the face (i.e. forehead,
cheeks, nose, and
chin).
-
Two pump actuations should be enough to cover the upper trunk (i.e.
reachable upper
back, shoulders a