DENOTAS 60 Solution for Injection 60 mg/ml

País: Tanzania

Idioma: inglés

Fuente: Tanzania Medicinces & Medical Devices Authority

Ingredientes activos:

Denosumab

Disponible desde:

Intas Pharmaceuticals Limited, INDIA

Código ATC:

Drugs Affecting Bone Structure And Mineralization

Designación común internacional (DCI):

Denosumab

Dosis:

60 mg/ml

formulario farmacéutico:

Solution for Injection

Fabricado por:

Intas Pharmaceuticals Limited, INDIA

Resumen del producto:

Physical description: Clear, colorless to slightly yellow solution; Local technical representative: PHARMAJEN LIMITED (61840)

Estado de Autorización:

Registered/Compliant

Fecha de autorización:

2022-07-19

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
DENOTAS
Denosumab 60 mg solution for injection in a prefilled syringe
Product legal distribution category: prescription-only medicine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 60 mg of denosumab in 1 mL of
solution (60 mg/mL).
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian
cell line (CHO)
by recombinant DNA technology.
Excipient with known effect:
This medicine contains 47 mg sorbitol in each mL of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
Denosumab is indicated for the:
(i)
Treatment of postmenopausal women with osteoporosis at high risk of
fracture
(ii)
Treatment to increase bone mass in men with osteoporosis at high risk
of fracture
(iii)
Treatment to increase bone mass in men at high risk for fracture
receiving androgen
deprivation therapy for non-metastatic prostate cancer
(iv)
Treatment to increase bone mass in women at high risk for fracture
receiving
adjuvant aromatase inhibitor therapy for breast cancer
2.
POSOLOGY AND METHOD OF ADMINISTRATION
During a phase III study in women with postmenopausal osteoporosis,
Intas Denosumab was
administered as single subcutaneous (SC) injection of 60 mg every 6
months in combination
with daily calcium and vitamin D.
Information provided below is based on the innovator data.
POSOLOGY
The recommended dose of denosumab is 60 mg administered as a single SC
injection once
every 6 months into the thigh, abdomen or upper arm.
Patients must be adequately supplemented with calcium 1000 mg daily
and at least 400 IU
vitamin D daily (see section 4.4).
The
optimal
total
duration
of
antiresorptive
treatment
for
osteoporosis
(including
both
denosumab
and
bisphosphonates)
has
not
been
established. The
need
for
continued
treatment should be re-evaluated periodically based on the benefits
and pot