IXIFI POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG VIAL

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Infliximab (PF-06438179)

Dostupné z:

PFIZER PRIVATE LIMITED

ATC kód:

L04AB02

Forma lieku:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Zloženie:

Infliximab (PF-06438179) 100mg / vial

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

Prescription Only

Výrobca:

Pfizer Manufacturing Belgium NV

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2020-06-03

Príbalový leták

IXIFI™
Infliximab
1.
NAME OF THE MEDICINAL PRODUCT
IXIFI Powder for Concentrate for Solution for Infusion 100 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains 100 mg of infliximab in a 15 mL vial.
After reconstitution with
10 mL of Sterile Water for Injection, each mL contains 10 mg of
infliximab.
Infliximab, the active ingredient in IXIFI, is a chimeric IgG1κ
monoclonal antibody
(composed of human constant and murine variable regions) specific for
human tumor
necrosis factor-alpha (TNFα), with an identical amino acid sequence
for the variable and
constant regions and identical primary structure with Remicade
(infliximab), the reference
product. It has a molecular weight of approximately 149 kilodaltons.
The manufacturing
process for infliximab drug substance uses a recombinant Chinese
hamster ovary (CHO) cell
line that contains the DNA encoding the sequence for infliximab and is
grown in suspension
culture using chemically-defined (CD), animal-derived component-free
(ACF) media.
3.
PHARMACEUTICAL FORM
White, lyophilized powder for intravenous (IV) infusion.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (RA)
IXIFI, in combination with methotrexate (MTX), is indicated for:
The reduction of signs and symptoms as well as the improvement in
physical function in
•
adult patients with active disease when the response to
disease-modifying drugs,
including MTX, has been inadequate.
•
adult patients with severe, active and progressive disease not
previously treated with
MTX or other disease-modifying anti-rheumatic drugs (DMARDs).
In these patient populations, a reduction in the rate of the
progression of joint damage, as
measured by X-ray, has been demonstrated (see Section 5.1).
CROHN’S DISEASE
IXIFI is indicated for:
•
Treatment of moderately to severely, active Crohn’s disease, in
adult patients who have
not responded despite a full and adequate course of therapy with a
corticosteroid and an
immunosuppressant; or who are intolerant to or have medi

Súhrn charakteristických

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IXIFI™
Infliximab
1.
NAME OF THE MEDICINAL PRODUCT
IXIFI Powder for Concentrate for Solution for Infusion 100 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains 100 mg of infliximab in a 15 mL vial.
After reconstitution with
10 mL of Sterile Water for Injection, each mL contains 10 mg of
infliximab.
Infliximab, the active ingredient in IXIFI, is a chimeric IgG1κ
monoclonal antibody
(composed of human constant and murine variable regions) specific for
human tumor
necrosis factor-alpha (TNFα), with an identical amino acid sequence
for the variable and
constant regions and identical primary structure with Remicade
(infliximab), the reference
product. It has a molecular weight of approximately 149 kilodaltons.
The manufacturing
process for infliximab drug substance uses a recombinant Chinese
hamster ovary (CHO) cell
line that contains the DNA encoding the sequence for infliximab and is
grown in suspension
culture using chemically-defined (CD), animal-derived component-free
(ACF) media.
3.
PHARMACEUTICAL FORM
White, lyophilized powder for intravenous (IV) infusion.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (RA)
IXIFI, in combination with methotrexate (MTX), is indicated for:
The reduction of signs and symptoms as well as the improvement in
physical function in
•
adult patients with active disease when the response to
disease-modifying drugs,
including MTX, has been inadequate.
•
adult patients with severe, active and progressive disease not
previously treated with
MTX or other disease-modifying anti-rheumatic drugs (DMARDs).
In these patient populations, a reduction in the rate of the
progression of joint damage, as
measured by X-ray, has been demonstrated (see Section 5.1).
CROHN’S DISEASE
IXIFI is indicated for:
•
Treatment of moderately to severely, active Crohn’s disease, in
adult patients who have
not responded despite a full and adequate course of therapy with a
corticosteroid and an
immunosuppressant; or who are intolerant to