SCABOMA LOTION

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

Gamma Benzene Hexachloride

Disponibil de la:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (nume internaţional):

Gamma Benzene Hexachloride

Unități în pachet:

100ml mL

Produs de:

GLENMARK PHARMACEUTICALS LTD

Prospect

Not Applicable

Caracteristicilor produsului

Manufactured by:
Plot No. E-37, 39, D-Road,
MIDC, Satpur, Nashik - 422 007,
Maharashtra State, India.
Trade Mark
PRODUCT REGISTRATION HOLDER
Glenmark Pharmaceuticals
(Malaysia) Sdn Bhd (660397-W)
D-31-02, Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
COMPOSITION
Lindane USP 1% w/v
Aqueous Base
q.s.
DESCRIPTION:
A printed carton containing an insert & labelled sealed amber
coloured glass bottles containing a white lotion with rose
perfume.
THERAPEUTIC INDICATIONS
SCABOMA lotion is indicated for the treatment of scabies
(infestations of Sarcoptes scabei) in patients who:
1. Cannot tolerate other approved therapies, OR
2. Have failed treatment with other approved therapies.
DOSAGE AND ADMINISTRATION
For Scabies (Sarcoptes Scabiei)
1) It is recommended 30ml of SCABOMA Lotion applied in a thin
layer to all areas of the body from the neck down and
thoroughly washed off after 8 hours. SCABOMA should not
be applied immediately after a bath or shower and should not
be used by persons with extensive dermatitis, or in pregnant
or lactating women.
2) The lotion should be applied thinly and rubbed in thoroughly
from the neck down to the soles of the feet, with special
attention under nail and to the hands, feet and interdigital
areas.
Avoid
applying
SCABOMA
to
open
cuts
or
excoriations.
3) The mite does not infest areas of sebaceous gland activity in
adults or children, and the face and scalp need not be treated.
However, scabies may affect the head in infants.
4) The lotion should be left on for 8 to 12 hours and removed by
thorough washing.
5) One application is usually curative although many patients
exhibit persistent pruritus after treatment. It is not known how
soon after SCABOMA administration that a second dose can
safety be readministered. Retreatment is not recommended.
PEDIATRIC USE: Animal data demonstrated increased risk of
adverse events in the young across species. Pediatric patients
have a higher surface to volume ratio and may be at risk of
greater systemic exposure when Lindane Lotion