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65502005
Articles
Safety in Lactation: Sympathomimetics for acute cardiac conditions
4 November 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Dobutamine, dopamine and dopexamine are inotropes…
What is the clinical significance of potential drug interactions with local anaesthetic preparations used in primary care dentistry?
30 July 2020This updated Medicines Q&A explores the clinical significance of potential interactions between dental local anaesthetic preparations and other medicines as listed in the BNF and…
Safety in Lactation: Drugs used for allergic conditions
22 May 2017Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Antihistamines Non-sedating antihistamines (NSA) are preferred…
Lactation Safety Information
For allergic emergencies
For allergic emergencies
-
No published evidence of safety
Low levels anticipated in milk due to very short half-life (2 minutes)
Minimal absorption from the infant’s GI tract
Considered safe for short-term emergency use
29 July 2020
Bibliography For cardiopulmonary resuscitation
Bibliography
For cardiopulmonary resuscitation
-
No published evidence of safety
Low levels anticipated in milk due to very short half-life (2 minutes)
Minimal absorption from the infant’s GI tract
Emergency use for CPR supercedes all other considerations
29 July 2020
New Medicines
Neffy (US) Anaphylaxis - intranasal formulation
Information
Neffy (US)
New formulation
Recordati
ARS Pharmaceuticals
Development and Regulatory status
None
Pre-registration (Filed)
Phase III Clinical Trials
Nov 20ARS announces acceptance of MAA submission by EMA. The MAA submission includes data from multiple clinical studies showing that 1 mg of Neffy achieves epinephrine exposures that are similar to a 0.3 mg epinephrine IM injection, with rapid absorption and clinical response based on surrogate endpoints. A dosage strength of 0.65 mg is under development for children weighing between 15kg and 30kg and is expected to be filed shortly after the initial approval [3].
Sep 20ARS Pharmaceuticals has entered an exclusive licensing agreement with Recordati) for marketing rights for ARS-1 in the EU, UK and several other countries [3].
Feb 19Granted fast track status in US [2].
Category
Alpha and beta adrenergic receptor agonist
The number of people who experience severe systemic allergic reactions is increasing. In the UK, incidence is about 1-3 reactions per 10,000 population per annum [1].
Anaphylaxis - intranasal formulation
Intranasal
Trial or other data
Sep 21The company anticipated 60% of epinephrine pen users will switch to Neffy immediately and 80% within two years [4].
Jun 19ARS announce topline results from EPI-04 study (n=36). Study demonstrates intranasal adrenaline spray has a similar pharmacokinetic profile to IM adrenaline in patients with allergic rhinitis, however, the former showed a faster time to peak exposure [2].