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Version 10 February 2012 CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation, Suspension Fluticasone propionate, Salmeterol xinafoate Date: 11.05.2015 This module reflects the scientific discussion for the approval of Salmeterol plus Fluticason Propionat momaja 25 Mikrogramm/250 Mikrogramm Druckgasinhalator, Suspension and Salmeterol plus Fluticason-propionat momaja 25 Mikrogramm/125 Mikrogramm Druckgasinhalator, Suspension. The procedure was finalised at 04.08.2014. For information on changes after this date please refer to the module ‘Update’. 1/26 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation, from Cipla Europe NV. The product is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonist. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(3)of Directive 2001/83/EC. Fluticasone propionate is a glucocorticoid anti-asthmatic inhalant (anti-inflammatory). Salmeterol xinafoate is a selective beta-2-adrenoceptor agonist (bronchodilator). II. QUALITY ASPECTS II.1 Introduction Salmeterol xinafoate and fluticasone propionate pressurised inhalation suspension comprises an aluminium canister with a suitable metering valve and a plastic actuator with dose indicator and fitted with dustcap in pouch with a silica gel bag. II.2 Drug Substance The active substances in Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation are salmeterol xinafoate and fluticasone propionate. The specification of the active substances meets the current scientific requirements. The adequate quality of the active substances has been shown by submitting the appropriate control data. The stability of the active substances has been tested under ICH conditions. The results of the stability studies support the established retest-period. 2/26 II.3 Medicinal Product Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation contains the following excipients: Propellant: Norflurane (HFA 134a) The manufacturers responsible for batch release are S&D Pharma CZ spol.s.r.o. and Cipla (EU) Limited. The development of the product has been sufficiently made and deemed appropriate. The usage of all the excipients has been described. The release specification includes the check of all parameters relevant to this pharmaceutical form. Appropriate data concerning the control of the finished product support the compliance with the release specifications. The packaging of the medicinal product complies with the current legal requirements. Stability studies under ICH conditions have been performed and data presented support the shelf life claimed in the SmPC, with a shelf life of 2 years when stored below 30°C. The pharmaceutical quality of Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation has been adequately shown. II.4 Discussion on chemical, pharmaceutical and biological aspects Information on development, manufacture and control of active substance and medicinal product has been presented in a satisfactory manner. The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics. III. NON-CLINICAL ASPECTS The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. III.1 Ecotoxicity/environmental risk assessment (ERA) Since Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.2 Discussion on the non-clinical aspects There are no objections to approval of Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation from a non-clinical point of view. 3/26 IV. CLINICAL ASPECTS IV.1 Introduction Product profile: 4.1 Therapeutic indications Salmeterol and Fluticasone propionate pressurised inhalation suspension is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta- 2-agonist. 4.2 Posology and method of administration Recommended Doses: Adults and adolescents 12 years and older: • Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily. Or • Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. Pharmacodynamics (extracted from the Clinical overview) Fluticasone propionate Fluticasone propionate is a corticosteroid designed for topical use. It is not suitable for oral administration as it is subject to almost 100% first-pass inactivation in the liver. It has a high affinity for the glucocorticoid receptor with negligible binding to the mineralocorticoid, estrogen, progesterone, and aldosterone receptors. Fluticasone propionate potentially has the effects anticipated for any corticosteroid: increasing protein catabolism, having anti-inflammatory actions, immunosuppressant action, being diabetogenic and impairing bone metabolism, thus promoting osteoporosis. Immunosuppressant activity was demonstrated by a decline in thymus weight in dog and rat studies. In common with other intranasal and inhaled steroids, fluticasone propionate has anti-inflammatory and immunosuppressant activity. Salmeterol Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist. Salmeterol xinafoate has pharmacologic actions similar to those of other selective β2- adrenergic receptor agonists (e.g., albuterol). Salmeterol stimulates β2-adrenergic receptors and apparently has little or no effect on α-, β1-, or β3-adrenergic receptors. The principal effect following oral inhalation of salmeterol and other β2-adrenergic agonists is bronchodilation resulting from relaxation of smooth muscles of the bronchial tree. Salmeterol 4/26 produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting beta-2-agonists. Salmeterol, like other β2-adrenergic agonists, can produce changes in heart rate and blood pressure (dose-related increases in heart rate of 3–16 beats/minute). At higher dosages, salmeterol administration has been associated with prolongation of the QTc interval. Administration of salmeterol and other β-adrenergic agonists may cause dose-related increases in blood glucose and/or decreases in serum potassium concentrations. Pharmacokinetics (extracted from the Clinical Overview) Fluticasone propionate Systemic absorption occurs mainly through the lungs and is initially rapid followed by a prolonged phase. The remainder of the inhaled dose may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and pre-systemic metabolism, resulting in oral availability of less than 1%. There is a linear increase in systemic exposure with increasing inhaled dose. The disposition of fluticasone propionate is characterized by high plasma clearance (1150 ml/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours. Plasma protein binding is 91%. Fluticasone propionate is cleared very rapidly from the systemic circulation. The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. Other unidentified metabolites are also found in the faeces. The renal clearance of fluticasone propionate is negligible. Less than 5% of the dose is excreted in urine, mainly as metabolites. The main part of the dose is excreted in the faeces as metabolites and unchanged drug. Salmeterol Limited data have been published on the pharmacokinetics of salmeterol. Moreover, there is no data on the extent to which inhaled salmeterol undergoes first-pass metabolism. Larger inhaled doses give approximately proportionally increased blood concentrations. Plasma salmeterol concentrations of 0.1 to 0.2 and 1 to 2 mcg/L have been attained in healthy volunteers about 5 to 15 minutes after inhalation of a single dose of 50 and 400 mcg, respectively. In patients who inhaled salmeterol 50 mcg twice daily for 10 months, a second peak concentration of 0.07 to 0.2 mcg/L occurred 45 to 90 minutes
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