Notice on suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5mg and 50 mg extended-release suspension for injection for intramuscular use
24.05.2010
The company Johnson & Johnson S.E. d.o.o., in collaboration with the Croatian Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional letter about the suspected quality defect of the medicinal product Rispolept Consta 25 mg, 37,5 mg and 50 mg extended-release suspension for injection for intramuscular use.
This defect was recently observed in the Needle-Pro, a recapping device for needles, part of the approved packaging of the medicinal product, used in order to administer the medicine. In some countries, an increased number of incidents was reported linked to separation of gluteal needle during the preparation and fastening of injection needle to the cylinder, before the medicine is administered. Also, there is an increased number of reports of leaking contents on the Alaris SmartSite Needle-Free Vial Access devices for reconstitution of suspension. In this letter, the marketing authorisation holder also provides detailed instructions for preparation of the needle for intramuscular administration and instructions for the use of Alaris SmartSite Needle-Free Vial Access device, which can be also found in the approved summary of product characteristics and the patient information leaflet for the medicinal product Rispolept Consta.
In the Republic of Croatia, no such defects have been reported.
The Croatian Agency for Medicinal Products and Medical Devices does not consider these defects to present a significant safety risk either to patients receiving the medicinal product, or to the healthcare professionals who administer it.
Healthcare professionals are invited, if they observe needle separation, leakage or some other medicinal product defect, to notify immediately the Croatian Agency for Medicinal Products and Medical Devices (citing quality defect of medicinal product) and the marketing authorisation holder in Croatia, Johnson & Johnson S.E. d.o.o.
The text of the letter can be found here. (available in Croatian language)
