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Codes ATC: A04AD01
EMLc
Indication
Palliative care Code ICD11: QC7A
Type de médicament
Chemical agent
Type de liste
Liste de base (EML)
(EMLc)
Formulations
Local > Topical > Transdermal patch: 1 mg per 72 hours transdermal patch (EMLc)
Parenteral > General injections > unspecified: 400 µg per mL injection (EMLc) ; 600 µg per mL injection (EMLc)
Historique des statuts LME
Ajouté pour la première fois en 2009 (TRS 958)
Sexe
Tous
Âge
Enfants (1 mois - 12 ans)
Équivalence thérapeutique
La recommandation concerne ce médicament spécifique
Renseignements sur le brevet
Patents have expired in most jurisdictions
Lire la suite sur les brevets.
Résumé des preuves et recommandation du comité d'experts
Hyoscine hydrobromide was added to the EMLc in 2009 for the management of excessive respiratory tract secretions in children receiving palliative care. The EMLc Subcommittee considered a review of medicines for palliative care commissioned by the Secretariat to ensure that appropriate medicines for the pharmacological management of the most prevalent and distressing symptoms in children with life-threatening and life-limiting conditions worldwide are included in the EMLc. The Subcommittee noted that malignancy and HIV/AIDS were identified as the most common causes of childhood mortality appropriate to palliative care worldwide and that the 10 most frequent symptoms and symptom clusters (fatigue and weakness, pain, anorexia and weight loss, delirium and agitation, breathlessness, nausea and vomiting, constipation, depression, excess respiratory tract secretions and anxiety) had been identified based on available data. The Subcommittee noted that the evidence to support efficacy and safety of medicines used in the management of these symptoms was generally weak and therefore, several recommendations in the proposal were based on experience from clinical practice. For the management of respiratory tract secretions, the proposal suggested that hyoscine hydrobromide may provide some benefit in terminal care. Despite the absence of data from large paediatric studies, the Subcommittee felt that the drug should be added to the EMLc. The Subcommittee particularly noted the potential usefulness of the patch presentation as an appropriate dosage form for use in children and decided, therefore to include the intravenous form and transdermal patch.