Onder 2.6. Gerechtshof Den Haag 27 februari 2018

[0024] An especially preferred example of an injection device for a single application according to the present invention is a ready-made syringe. Ready-made syringes are well-known in the pharmaceutical field, in particular also in the treatment of rheumatoid arthritis with methotrexate. Ready-made syringes containing methotrexate solutions with concentrations of 7.5 mg/ml, 10.0 mg/ml and 25 mg/ml are already being distributed on the German market (trade names: Lantarel® of the company Wyeth, Metex® of the applicant, whereby the commercial product Lantarel® FS 25 mg is not approved for subcutaneous application). Although the provision of methotrexate solutions in ready-made syringes, some for self-application, have had a positive impact on patient compliance, the prior art preparations that are approved for subcutaneous application have the disadvantage that, depending on the amount of active substance to be administered in each week, relatively large amounts of liquid have to be injected under the patient's skin. In the case of a common weekly dosage of active substance of 30 mg, this means that based on the currently highest concentration of active substance solution for subcutaneous application of the prior art, namely 10 mg/ml (in the commercial product Metex® 10 mg/ml of the applicant), a volume of 3 ml has to be injected under the skin. This large amount of liquid is often hard to convey to the patient, in particular children, which leads to a reduced patient compliance.

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