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300mg

4.2 Posology and method of administration

Ulcerative colitis

Maintenance dose

The maintenance dose is 200 mg (i.e. two 100 mg pre‑filled syringes or two 100 mg pre‑filled pens) by subcutaneous injection every 4 weeks after completion of induction dosing. It can be administered either as two pre‑filled syringes or pre-filled pens of 100 mg each, or as one pre‑filled syringe or pre-filled pen of 200 mg.

For the posology of the subcutaneous dosing regimen, see section 4.2 of the Summary of Product Characteristics for Omvoh 100 mg and Omvoh 200 mg solution for injection in pre‑filled syringe and Omvoh 100 mg and Omvoh 200 mg solution for injection in pre‑filled pen.

Crohn's disease

Maintenance dose

The maintenance dose is 300 mg (i.e. one pre‑filled syringe or pre‑filled pen of 100 mg and one pre‑filled syringe or pre-filled pen of 200 mg) by subcutaneous injection every 4 weeks after completion of induction dosing.

The injections may be administered in any order.

The 200 mg pre-filled syringe and 200 mg pre-filled pen are only for the treatment of Crohn’s disease.

5.1 Pharmacodynamic properties

Minor changes to footnotes of Table 5

100mg and 200mg

4.2 Posology and method of administration

Ulcerative colitis

Maintenance dose

The maintenance dose is 200 mg (i.e. two pre-filled syringes or two pre-filled pens) by subcutaneous injection every 4 weeks after completion of induction dosing. It can be administered either as two pre‑filled syringes or pre-filled pens of 100 mg each, or as one pre‑filled syringe or pre-filled pen of 200 mg.

Crohn's disease

Maintenance dose

The maintenance dose is 300 mg (i.e. one pre‑filled syringe or pre‑filled pen of 100 mg and one pre‑filled syringe or pre‑filled pen of 200 mg) by subcutaneous injection every 4 weeks after completion of induction dosing.

The injections may be administered in any order.

The 200 mg pre-filled syringe and the 200 mg pre-filled pen are only for the treatment of Crohn’s disease.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.

5.1 Pharmacodynamic properties

Minor changes to footnotes of Table 5

6.5 Nature and contents of container

Not all pack sizes may be marketed. 

Omvoh 200 mg solution for injection in pre-filled syringe

2 mL solution in a type I clear glass syringe. 

The syringe is encased in a disposable, single‑dose syringe with bromobutyl rubber plunger. 

Pack sizes: 

·               packs of 1 pre-filled syringe 

·               multipacks containing 3 (3 packs of 1) pre-filled syringes. 

Not all pack sizes may be marketed. 

Omvoh 200 mg solution for injection in pre-filled pen

2 mL solution in a type I clear glass syringe. 

The syringe is encased in a disposable, single‑dose pen with bromobutyl rubber plunger. 

Pack sizes: 

·        packs of 1pre-filled pen 

·        multipacks containing 3 (3 packs of 1) pre-filled pens. 

Not all pack sizes may be marketed. 

8.     Market Authorisation Numbers

Omvoh 200 mg solution for injection in pre-filled syringe

EU/1/23/1736/012

EU/1/23/1736/013

Omvoh 200 mg solution for injection in pre-filled pen

EU/1/23/1736/014

EU/1/23/1736/015

Disposing of Omvoh

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Disposing of Omvoh

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3.             How to use Omvoh

How much Omvoh is given and for how long

Crohn’s disease

Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be given by an injection under the skin (‘subcutaneously’) and then every 4 weeks. The maintenance dose of 300 mg will be given by using 2 injections: one containing 100 mg (1 mL) of Omvoh and one containing 200 mg (2 mL) Omvoh. The injections may be administered in any order.

The 200 mg pre-filled pen is only for treatment of Crohn’s disease.

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6.      Contents of the pack and other information

What Omvoh looks like and contents of the pack

Omvoh is a solution in a clear glass cartridge encased in a disposable, single-use pen. Its colour may vary from colourless to slightly yellow.

Omvoh is available in packs containing 2 pre-filled pens of 100 mg, in multipacks comprising 2 cartons, each containing 2 pre-filled pens of 100 mg and in multipacks comprising 3 cartons, each containing 2 pre‑filled pens of 100 mg.

Not all pack sizes may be marketed.

This is a new PIL for a new presentation

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3.         How Omvoh is used

     Ulcerative colitis  

  Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be given by an injection under the skin (‘subcutaneously’) and then every 4 weeks. The maintenance dose of 200 mg will be given by using either 2 injections each containing 100 mg of Omvoh or 1 injection containing 200 mg of Omvoh.

Crohn’s disease

·           Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be given by an injection under the skin (‘subcutaneously’) and then every 4 weeks. The maintenance dose of 300 mg will be given by one pre‑filled syringe or pen of 100 mg and one pre‑filled syringe or pen of 200 mg. The injections may be administered in any order.

The 200 mg pre-filled syringe or pen is only for treatment of Crohn’s disease.