TREMFYA

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

GUSELKUMAB

Доступно од:

J-C HEALTH CARE LTD

АТЦ код:

L04AC16

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

GUSELKUMAB 100 MG / 1 ML

Пут администрације:

S.C

Тип рецептора:

Required

Произведен од:

CILAG AG, SWITZERLAND

Терапеутска област:

GUSELKUMAB

Терапеутске индикације:

Plaque psoriasisTremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Датум одобрења:

2023-04-30

Информативни летак

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
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Карактеристике производа

1
TREMFYA_PI_March 2022
1.
NAME OF THE MEDICINAL PRODUCT
Tremfya
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tremfya 100 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 100 mg of guselkumab in 1 mL
solution.
Tremfya 100 mg solution for injection in pre-filled pen
Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution
Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ)
monoclonal antibody (mAb) to the
interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO)
cells by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
The solution is clear and colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plaque psoriasis
Tremfya is indicated for the treatment of adults with moderate to
severe plaque psoriasis who
are candidates for systemic therapy or phototherapy.
Psoriatic arthritis
Tremfya, alone or in combination with methotrexate (MTX), is indicated
for the treatment of active
psoriatic arthritis in adult patients who have had an inadequate
response or who have been intolerant to a
prior disease-modifying antirheumatic drug (DMARD) therapy (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tremfya is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of conditions for which Tremfya is indicated.
Posology
Plaque psoriasis
The recommended dose of Tremfya is 100 mg by subcutaneous injection at
weeks 0 and 4, followed
by a maintenance dose every 8 weeks.
Consideration should be given to discontinuing treatment in patients
who have shown no response
after 16 weeks of treatment.
Psoriatic arthritis
The recommended dose of Tremfya is 100 mg by subcutaneous injection at
weeks 0 and 4, followed
by a maintenance dose every 8 weeks. For patients at high risk for
joint damage according to clinical
2
TREMFYA_PI_March 2022
judgement, a dose of 100 mg every 4 weeks may be considered (see
sect