Pliaglis 70 mgg + 70 mgg cream

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

LIDOCAINE; tetracaine

Fáanlegur frá:

MIGRIS LIFE SCIENCES SDN BHD

INN (Alþjóðlegt nafn):

LIDOCAINE; tetracaine

Einingar í pakka:

15 gm mcg/mL; 30 gm mcg/mL

Framleitt af:

LABORATORIES GALDERMA

Vara einkenni

1 (11)
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pliaglis 70mg/g + 70mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of cream contains 70mg lidocaine (lignocaine) and 70 mg
tetracaine.
Excipients with known effect:
methyl parahydroxybenzoate (E218) 0.5 mg/g
propyl parahydroxybenzoate (E216) 0.1 mg/g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White to off-white viscous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pliaglis is indicated in adults to produce local dermal anaesthesia on
intact skin prior to
dermatological procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For use in adults and elderly:
For dermatological procedures such as pulsed-dye laser therapy,
laser-assisted hair removal, non-
ablative laser facial resurfacing, dermal filler injections and
vascular access, Pliaglis should be applied
onto intact skin at a thickness of approximately 1mm for 30 minutes
(approximately 1.3 g of cream
2 (11)
per 10 cm2). After the required time, the peel must then be removed
from the skin prior to the
procedure.
For dermatological procedures such as laser-assisted tattoo removal,
and laser leg vein ablation,
Pliaglis should be applied onto intact skin at a thickness of
approximately 1mm for 60 minutes
(approximately 1.3 g of cream per 10 cm2). After the required time,
the peel must then be removed
from the skin prior to the procedure.
SURFACE AREA OF TREATMENT SITE
(CM2)
APPROXIMATE WEIGHT OF PLIAGLIS
DISPENSED (G)
10
1.3
2 fingertip units
50
6.5
Half content of a 15g tube
100
13
Full content of a 15g tube
200
26
Full content of a 30g tube
400
52
Full content of two 30g tubes
The maximum application area should not exceed 400 cm2.
Hepatic, renal and cardiac impairment
Pliaglis should be used with caution in patients with hepatic, renal
and cardiac impairment (see
section 4.4).
Paediatric population
The safety and efficacy of Pliaglis in children and adolescents aged
up to 18 years have not been
established. Therefore, the