PHORCAL Ointment

Ország: Tanzánia

Nyelv: angol

Forrás: Tanzania Medicinces & Medical Devices Authority

Aktív összetevők:

Calcitriol

Beszerezhető a:

Kusum Healthcare Private Limited, INDIA

ATC-kód:

Antipsoriatics for topical use

INN (nemzetközi neve):

Calcitriol

Adagolás:

3/1

Gyógyszerészeti forma:

Ointment

Gyártó:

Kusum Healthcare Pvt. Ltd, INDIA

Termék összefoglaló:

Physical description: White or almost white smooth ointment.; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Engedélyezési státusz:

Registered/Compliant

Engedély dátuma:

2022-04-11

Termékjellemzők

SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Phorcal Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_COMPOSITION_:
_Active substance: _Calcitriol; One gram of ointment contains:
Calcitriol BP
3 mcg
...........................
_For full list of excipients, see section 6.1 _
3.
PHARMACEUTICAL FORM
Ointment
Prescription Only Medicine
DESCRIPTION: White or almost white uniform ointment.
4.
CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Topical treatment of mild to moderately severe plaque psoriasis
(psoriasis vulgaris) with up to
35% of body surface area involvement.
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
ADMINISTRATION AND DOSAGE
Phorcal Ointment should be applied to the psoriasis affected areas
twice per day, once in the
morning and once in the evening before retiring and after washing. It
is recommended that not
more than 35% of the body surface be exposed to daily treatment. Not
more than 30 g of ointment
should be used per day. There is limited clinical experience available
for the use of this dosage
regimen of more than 6 weeks.
PAEDIATRIC POPULATION
In view of the particular sensitivity of neonates versus adult rodents
to the toxic effects of calcitriol,
exposure of children to calcitriol ointment should be avoided.
4.3 CONTRAINDICATIONS
Patients on systemic treatment of calcium homeostasis.
Patients with kidney or liver dysfunction.
Patients with hypercalcaemia and patients known to suffer from
abnormal calcium metabolism.
Patients with known hypersensitivity to the active substance or to any
of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The ointment can be applied to the face with caution, as there is an
increased risk of irritation in
this area. Contact with the eyes should be avoided. The hands should
be washed after applying
the ointment in order to avoid unintentional application to non
lesional areas. Not more than 35% of
the body surface should be exposed to daily treatment. Not more than
30g of ointment should be
used per day.
Due to potential