Access: This Cover Virtually Everything Around PR-171
Methods Design The YES1 DIAmorphine SAFEty (DIASAFE) study was a multicentre, open-label, single-dose, pharmacovigilance study in children in the ED (recruiting April 2010�CSeptember 2011). The study was approved by the regulatory authority and appropriate research ethics committees. Eight EDs took part in the safety study (see acknowledgements). Population Patients aged between 2 years and PR-171 cost diamorphine in the preceding 7?days, or contraindications to the medication or excipients. Treatment The product (Ayendi) comprises diamorphine hydrochloride BP presented as a white freeze-dried powder in a vial (device bottle), together with separate diluent for reconstitution (preserved 0.5% saline). The nasal spray is designed as a multiuse product with replacement of the AZD9291 in vitro paediatric tip and priming between patients. The diamorphine is delivered at a single dose of 0.1?mg/kg��20%, using a total of 2�C4 actuations of the appropriate product strength directed into alternate nostrils, according to weight. It is provided in two strengths: 144 mg and 320?mg, providing 720 ��g and 1600?��g diamorphine hydrochloride per actuation (50?��L), respectively, following reconstitution. The maximum volume administered per nostril is 100?��L; the maximum total dose is 4.8?mg diamorphine hydrochloride (three sprays of 1600?��g/actuation product). The small nasal volume administered ensures that absorption of the whole dose occurs transmucosally in the nares. Each study site was provided with the two product strengths in vials together with diluent. The diluent was added to the bottle, the nasal spray pump (with paediatric nasal tip) attached, and devices were prepared for initial use by priming the spray eight times. Once reconstituted, sprays were stable at room temperature and could remain in the controlled drug cabinet for up to 14?days for multipatient use. A new paediatric tip was used for each patient, with the spray being primed twice between patients. Additional pain relief was allowed and was recorded.
