Safe’n’Sound® is on the market in Europe with a newly registered injectable medication.
The commercial launch of HULIO™ (Adalimumab Biosimilar) was initiated in selected European markets on October 19,2018.
Hulio™, developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and
marketed in the European Union by Mylan N.V. is approved as a biosimilar
for the same indications as the reference product, Humira®.
This formulation received market authorizations with Terumo proprietary PLAJEX™ pre-filled syringe, in combination with Nemera 1ml Safe’n’Sound add-on safety device.
In the parenteral industry, needlestick injuries are a global concern, all the more with the growing trend of self-administration. According to World Health Organization, over 3 million exposures to blood occur every year, resulting in health, psychological and cost issues.
To ensure adherence and user well-being, Nemera has developed Safe’n’Sound®, a fully passive safety device for prefilled syringes. With an ergonomic and robust design, it helps in preventing needle stick injuries, providing a user-friendly protection for healthcare professionals or patients.
This add-on device has been developed for healthcare professionals, patients with self-administered prescribed medications, or individuals that assist self-injecting patients.
Safe’n’Sound® is a customizable platform, compatible with prefilled ISO standard glass syringes as well as PLAJEX™ COP syringe, for 1ml or 2.25ml.
Not only does Safe’n’Sound® improve users safety and injection, but also the device complies with the recommendations of the World Health Organization, US FDA (US Federal Needle stick Prevention Act, 2000) and the EU Medical Device Regulation 2017/745 (MDR).
To find out more, contact us.
About Nemera
Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its expertise covers all five modes of delivery: Nasal/Buccal/Auricular (spray pumps, actuators, valves, etc.), Ophthalmic (preservative-free droppers), Pulmonary (pMDI, MDI’s, DPI’s), Dermal /Transdermal (airless & atmospheric dispensers), and Parenteral (autoinjectors, pens, and safety devices). Nemera provides solutions for the pharmaceutical industry, including standard innovative products, the development of proprietary devices and contract manufacturing.
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