AKLIEF CREAM

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Galderma Laboratories S.A. (Pty) Ltd

כמות:

50,0 μg

טופס פרצבטיות:

CREAM

הרכב:

EACH 1,0 g CREAM CONTAINS TRIFAROTENE 50,0 μg

מצב אישור:

Old Medicine

עלון מידע

Applicant: Galderma Laboratories South Africa (Pty) Ltd
Product name: Aklief
Dosage form: Cream
Strength:50 µg Trifarotene per 1 g of cream
Registration number: 56/13.12/1007
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Aklief 50 microgram/g cream
Trifarotene
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING AKLIEF
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, nurse
or other health
care provider.
•
Aklief has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What Aklief is and what it is used for
2.
What you need to know before you use Aklief
3.
How to use Aklief
4.
Possible side effects
5. How to store Aklief
6.
Contents of the pack and other information
1. WHAT AKLIEF IS AND WHAT IT IS USED FOR
Aklief contains the active substance trifarotene that belongs to a
group of medicines called
retinoids.
S3
Applicant: Galderma Laboratories South Africa (Pty) Ltd
Product name: Aklief
Dosage form: Cream
Strength:50 µg Trifarotene per 1 g of cream
Registration number: 56/13.12/1007
Page 2 of 9
Aklief is used for the cutaneous treatment of Acne Vulgaris of the
face and/or the trunk in
patients from 12 years of age and older, when many comedones
(whiteheads and
blackheads), papules and pustules (inflammatory pimples) are present.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AKLIEF
DO NOT USE AKLIEF:
- If you are allergic to trifarotene or any of the other ingredients
of this medicine (listed in
section 6)
- If you are a woman planning pregnancy or if you are pregnant (see
section “Pregnancy
and breastfeeding”)
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH AKLIEF:
Talk to your doctor or health care provider before using Aklief.
• Redness, peeling, dryness, and stinging/burning may be experienced
with the use of
Aklief (see section 4 “Possi

מאפייני מוצר

Applicant: Galderma Laboratories South Africa (Pty) Ltd
Product name: Aklief
Dosage form: Cream
Strength:50 µg Trifarotene per 1 g of cream
Registration number: 56/13.12/1007
Page 1 of 17
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S3
1. NAME OF THE MEDICINE
Aklief 50 microgram/g cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 50 micrograms of trifarotene.
_Excipients with known effect_
One gram of cream contains 300 milligrams of propylene glycol (E1520)
and 50 milligrams of
ethanol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
White and homogenous cream
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Aklief is indicated for the cutaneous treatment of moderate _Acne
Vulgaris_ of the face and/or the
trunk in patients from 12 years of age and older, when many comedones,
papules and pustules
are present.
Applicant: Galderma Laboratories South Africa (Pty) Ltd
Product name: Aklief
Dosage form: Cream
Strength:50 µg Trifarotene per 1 g of cream
Registration number: 56/13.12/1007
Page 2 of 17
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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 medical practitioner assesses the continued
improvement of the
patient after three months of treatment.
SPECIAL POPULATIONS
_Renal and Hepatic impairment _
Aklief has not been studied in patients with renal and hepatic
impairment.
_Elderly patients _
The safety and efficacy of Aklief in elderly patients aged 65 years
and above have not been
established.
PAEDIATRIC POPULATION
The safety and efficacy of Aklief in children below 12 years old have
not been established.
METHOD OF ADMINISTRATION
Cutaneous 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 fa