SILAPO Solution for injection in pre-filled syringe Ref.[49811] Active ingredients: Epoetin zeta

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany

Product name and form

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe.
Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe.
Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe.
Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe.
Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe.
Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe.
Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe.
Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe.
Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe.
Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe.
Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe.

Pharmaceutical Form
Solution for injection in pre-filled syringe (injection). Clear, colourless solution.

Qualitative and quantitative composition

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.3 mL solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.15 mg phenylalanine.

Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.6 mL solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.30 mg phenylalanine.

Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.9 mL solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.45 mg phenylalanine.

Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.4 mL solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.20 mg phenylalanine.

Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.5 mL solution for injection contains 5 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.25 mg phenylalanine.

Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.6 mL solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.30 mg phenylalanine.

Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.8 mL solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.40 mg phenylalanine.

Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 1 mL solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.50 mg phenylalanine.

Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.5 mL solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.25 mg phenylalanine.

Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 0.75 mL solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.38 mg phenylalanine.

Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe

1 pre-filled syringe with 1 mL solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.

Excipient with known effect: Each pre-filled syringe contains 0.50 mg phenylalanine.

For the full list of excipients, see section 6.1.

^* Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.

Active Ingredient	Description
Epoetin zeta	Epoetin zeta is a recombinant human erythropoietin. Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. The 2 are indistinguishable on the basis of functional assays.

List of Excipients
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)

Pack sizes and marketing

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe:

0.3 mL solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard device.