IDACIO Solution for injection Ref.[107082] Active ingredients: Adalimumab

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Fresenius Kabi Ltd, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, United Kingdom

Product name and form

Idacio 40 mg solution for injection in pre-filled syringe.

Idacio 40 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution.

Qualitative and quantitative composition

Idacio 40 mg solution for injection in pre-filled syringe: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.

Idacio 40 mg solution for injection in pre-filled pen: Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.

Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Adalimumab

Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
List of Excipients

Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Mannitol
Sodium chloride
Citric acid monohydrate
Sodium citrate
Polysorbate 80
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Idacio 40 mg solution for injection in pre-filled syringe

0.8 ml solution in pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with a latex-free needle cap, a plunger stopper (synthetic rubber), extended finger flanges and a passive needle shield.

Pack sizes of:

  • 2 pre-filled syringes, with 2 alcohol pads
  • 6 pre-filled syringes, with 6 alcohol pads

Idacio 40 mg solution for injection in pre-filled pen

0.8 ml solution in pre-filled PhysiojectTM pen containing a pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with latex-free needle cap and a plunger stopper (synthetic rubber). The pen is a single use, disposable, handheld, mechanical injection device.

Pack sizes of:

  • 2 pre-filled pens, with 2 alcohol pads
  • 6 pre-filled pens, with 6 alcohol pads

Not all presentations may be marketed.

Not all presentations may be marketed.

Marketing authorization holder

Fresenius Kabi Ltd, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, United Kingdom

Marketing authorization dates and numbers

Idacio 40 mg solution for injection in pre-filled syringe: PLGB 08828/0321

Idacio 40 mg solution for injection in pre-filled pen: PLGB 08828/0322

01/01/2021

Drugs

Drug Countries
IDACIO Albania, Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom
 
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