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KINERET Solution for injection (2019)

Active ingredients: Anakinra

Product Name and Form

Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.

Pharmaceutical form

Solution for injection (injection).

Clear, colourless-to-white solution for injection that may contain some product-related translucentto-white amorphous particles.

Qualitative and Quantitative Composition

Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).

* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Anakinra

Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI). Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.

List of excipients

Citric acid, anhydrous
Sodium chloride
Disodium edetate dihydrate
Polysorbate 80
Sodium hydroxide
Water for injections

Pack sizes and Marketing

0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle. The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover. None of the syringe or needle shield components are made with natural rubber latex.

Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

Date of first authorisation: 8 March 2002
Date of latest renewal: 20 March 2007

Marketing authorization number:

EU/1/02/203/005 – 1-pack
EU/1/02/203/006 – 7-pack
EU/1/02/203/007 – 28-pack