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Tremfya 100 mg solution for injection
2018-06-08 14:49:52 来源: 作者: 【 】 浏览:926次 评论:0
Tremfya 100 mg solution for injection
Janssen-Cilag Ltd
contact details
Active ingredient
guselkumab
Legal Category
POM: Prescription only medicine 
1. Name of the medicinal product

Tremfya 100 mg solution for injection.

2. Qualitative and quantitative composition

Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.

Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection (injection)

The solution is clear and colourless to light yellow.

4. Clinical particulars
 
4.1 Therapeutic indications

Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

4.2 Posology and method of administration

Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.

Posology

The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.

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