HUMIRA SOLUTION FOR INJECTION 80MG0.8ML (PREFILLED PEN)

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Adalimumab

Dostępny od:

ABBVIE PTE. LTD.

Kod ATC:

L04AB04

Forma farmaceutyczna:

INJECTION, SOLUTION

Skład:

Adalimumab 80.0mg/0.8mL

Droga podania:

SUBCUTANEOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Vetter Pharma-Fertigung GmbH & Co. KG (Schützenstrasse)

Status autoryzacji:

ACTIVE

Data autoryzacji:

2020-03-19

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HUMIRA 80 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
HUMIRA 80 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
adalimumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Humira is and what it is used for
2.
What you need to know before you use Humira
3.
How to use Humira
4.
Possible side effects
5.
How to store Humira
6.
Contents of the pack and other information
7.
Injecting Humira
1.
WHAT HUMIRA IS AND WHAT IT IS USED FOR
Humira contains the active substance adalimumab.
Humira is used to treat

Rheumatoid arthritis

Plaque psoriasis

Hidradenitis suppurativa

Crohn’s disease

Ulcerative colitis

Non-infectious uveitis
The active ingredient in Humira, adalimumab, is a human monoclonal
antibody. Monoclonal antibodies
are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor
(TNFα), which is involved in the
immune (defence) system and is present at increased levels in the
inflammatory diseases listed above. By
attaching to TNFα, Humira decreases the process of inflammation in
these diseases.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints.
Humira is used to treat moderate to severe rheumatoid arthritis in
adults. You may first be given other
disease-modifying medicines, such as methotrexate. If you do not
respond well enough to these medicines,
you will be given Humira.
2
Humira, when used with methotrexate, can also be used to treat seve

Charakterystyka produktu

1
HUMIRA
®
Adalimumab
PRODUCT NAME
Adalimumab solution for injection in pre-filled syringe
Adalimumab solution for injection in pre-filled pen
Adalimumab solution for injection in single use pre-filled glass vial
TRADE NAME
Humira
®
Humira (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody containing only human peptide
sequences. Humira was created using phage display technology resulting
in fully human heavy and light chain variable regions,
which confer specificity to human tumor necrosis factor (TNF), and
human IgG1 heavy chain and kappa light chain sequences.
Humira binds with high affinity and specificity to soluble tumor
necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta).
Adalimumab is produced by recombinant DNA technology in a mammalian
cell expression system. It consists of 1330 amino
acids and has a molecular weight of approximately 148 kilodaltons.
Humira is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous administration. The solution of
Humira is clear and colorless, with a pH of 5.2. The drug product is
supplied as either a single-use 1 mL pre-filled glass syringe,
1 mL single-use glass vial or as a single-use pre-filled Pen (Humira
Pen). Enclosed within the Pen is a single-use, 1 mL pre-
filled glass syringe.
Inactive ingredients for Humira 20 mg per 0.2 mL (100 mg/mL) include:
8.4 mg mannitol, 0.2 mg polysorbate 80, and water for
injection.
Inactive ingredients for Humira 40 mg per 0.8 mL (50 mg/mL) include:
4.93 mg sodium chloride, 0.69 mg monobasic sodium
phosphate dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24
mg sodium citrate, 1.04 mg citric acid monohydrate,
9.6 mg mannitol, 0.8 mg polysorbate 80, sodium hydroxide, as needed
(for pH adjustment) and water for injection per 0.8 mL.
Inactive ingredients for Humira 40 mg per 0.4 mL (100 mg/mL) include:
16.8 mg mannitol, 0.4 mg polysorbate 80, and water for
injection.
Inactive ingredients for Humira 80 mg per 0.8 mL (100 mg/mL) include:
33.6 mg mannitol, 0.8 mg poly