HUMIRA SOLUTION FOR INJECTION 40MG0.8ML (VIAL)

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Adalimumab

Հասանելի է:

ABBVIE PTE. LTD.

ATC կոդը:

L04AB04

Դոզան:

40.0 mg

Դեղագործական ձեւ:

INJECTION

Կազմը:

Adalimumab 40.0 mg

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

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

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2014-09-19

Տեղեկատվական թերթիկ

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.  Each  single  use  pre-
filled syringe or pen or single use pre-filled glass vial of 
Humira contains 40 mg adalimumab per 0.8 mL (50mg/mL).  
Inactive  ingredients  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, 
water for injection and sodium hydroxide per 0.8 mL.  
CLINICAL PHARMACOLOGY  

GENERAL  
Adalimumab binds specifically to TNF and neutralizes the biologi

Ապրանքի հատկությունները

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