Approvals/HSA/FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION

Approved

THERAPEUTIC

FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION

BESPAK HC LIMITED (UNITED KINGDOM)🇸🇬 Health Sciences Authority

Approval Date: May 19, 2014
Approval ID: 677780d80a0cd566
Company: BESPAK HC LIMITED (UNITED KINGDOM)
Type: Therapeutic

Approval Details

Approval Id: 677780d80a0cd566
Drug Name: FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION
Product Name: FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION
Approval Number: SIN14550P
Approval Date: 2014-05-19
Registrant: ZUELLIG PHARMA PTE. LTD.
Licence Holder: ZUELLIG PHARMA PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: AEROSOL, METERED
Dosage: 4.2 Posology and method of administration Posology For inhalation use. Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform® inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once control of asthma is achieved with the lowest strength of Flutiform® inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important. There are no data available for use of Flutiform® inhaler in patients with COPD. Flutiform® inhaler should not be used in patients with COPD. Patients should be given the strength of Flutiform® inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Flutiform® 50 microgram/5 microgram per actuation, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β2 agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed. Flutiform® inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses). Flutiform® 50 microgram/5 microgram inhaler – only Recommended dose for adults, adolescents and children aged 5 years and above: Flutiform® 50 microgram/5 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening. For adults and adolescents If the patient’s asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product – i.e. Flutiform® 125 microgram/5 microgram inhaler – two inhalations (puffs) twice daily. This strength should not be used in children under age of 12 years. For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform® 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents and children. Children under 5 years: Experience in children under the age of 5 years is limited (see sections 4.4, 4.8, 5.1 & 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Flutiform® inhaler in any strength is not recommended for use in children less than 5 years of age; Flutiform® inhaler should not be used in this young age group. Flutiform® 125 microgram/5 microgram inhaler – only Recommended dose for adults and adolescents aged 12 years and above: Flutiform® 125 microgram/5 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening. Patients may be transferred to the lowest strength of this combination product i.e. Flutiform® 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained. For adults only: The total daily dose can be further increased if asthma remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform® 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents aged 12 years and above. Children under 12 years: No data are available for this strength of Flutiform® inhaler in children. Experience in children under the age of 12 years is limited (see sections 4.4, 4.8, 5.1 & 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Flutiform® inhaler in any strength is not recommended for use in children less than 12 years of age; Flutiform® inhaler should not be used in this young age group. Flutiform® 250 microgram/10 microgram inhaler – only Recommended dose for adults: Flutiform® 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening. Patients may be transferred to a lower strength of this combination product i.e. Flutiform® 125 microgram/5 microgram inhaler or ultimately Flutiform® 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Adolescents under 18 years and children: No data are available for this strength of Flutiform® inhaler in children or adolescents. Experience in children is limited to the lowest strength (50 microgram/5 microgram) (see sections 4.4, 4.8, 5.1 & 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Flutiform® inhaler in any strength is not recommended for use in adolescents or children; Flutiform® inhaler should not be used in this young age group. Flutiform® 250 microgram/10 microgram inhaler should not be used in adolescents and children. However there are lower strengths available i.e. 50 microgram/5 microgram per actuation or 125 microgram/5 microgram per actuation which may be used in adolescents. Flutiform® inhaler – all strengths Special patient groups: There is no need to adjust the dose in elderly patients. There are no data available for use of Flutiform® inhaler in patients with hepatic or renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained. As the fractions of fluticasone and formoterol which reach systemic circulation are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment. General information: Inhaled corticosteroids alone are the first line of treatment for most patients. Flutiform® inhaler is not intended for the initial treatment of mild asthma. For patients with severe asthma the inhaled corticosteroid therapy should be established before prescribing a fixed-dose combination product. Patients should be made aware that Flutiform® inhaler must be used daily for optimum benefit, even when asymptomatic. Patients using Flutiform® inhaler should not use additional long-acting β2 agonists for any reason. If asthma symptoms arise in the period between doses, an inhaled, short-acting β2 agonist should be taken for immediate relief. For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of Flutiform® 125 microgram/5 microgram inhaler. Use of a spacer device with Flutiform® inhaler is recommended in patients who find it difficult to synchronise aerosol actuation with inspiration of breath. The AeroChamber Plus® is the only spacer device recommended for use with Flutiform® inhaler. Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. Re-titration to the lowest effective dose should always follow the introduction of a spacer device. Method of administration For inhalation use. To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professionals. The correct use of the pressurised metered dose inhaler (pMDI) is essential for successful treatment. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use and pictograms in the leaflet. The actuator has an integrated dose indicator which counts down the number of actuations (puffs) remaining. When this is getting near to zero the patient should be advised to contact their prescriber for a replacement inhaler. The inhaler must not be used after the dose indicator reads “0”. Priming the inhaler Before using the inhaler for the first time, or if the inhaler has not been used for 3 days or more, or after exposure to freezing or refrigerated conditions (see section 6.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) the inhaler must be primed before use: <ul> <li>Remove the mouthpiece cover and shake the inhaler well.</li> <li>Actuate (puff) the inhaler whilst pointing it away from the face. This step must be performed 4 times.</li> <li>The inhaler should always be shaken immediately before use.</li> </ul> Whenever possible patients should stand or sit in an upright position when inhaling from the inhaler. Steps to follow when using the inhaler: <ol> <li>Remove the mouthpiece cover and check that the mouthpiece is clean, and free from dust and dirt. The inhaler should be shaken immediately before releasing each actuation (puff).</li> <li>Breathe out as far as is comfortable and as slowly and deeply as possible.</li> <li>Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Hold the inhaler upright with a thumb(s) on the base of the mouthpiece and a forefinger/index finger(s) on the top of the inhaler. Do not bite the mouthpiece.</li> <li>At the same time, breathe in slowly and deeply through the mouth. After starting to breathe in press down on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply.</li> <li>Patients should continue to hold their breath for as long as is comfortable (optimally about 10 seconds), then breathe out slowly. Do not breathe out into the inhaler.</li> <li>Keep the inhaler in a vertical position for about half a minute, shake the inhaler, and repeat steps 2 to 5.</li> <li>After use, replace the mouthpiece cover.</li> </ol> IMPORTANT: Do not perform steps 2 to 5 too quickly. Patients may be advised to practise their technique in front of a mirror. If a mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2. For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler. Patients should rinse their mouth, gargle with water or brush the teeth after inhaling and spit out the residue to minimise the risk of oral candidiasis or dysphonia. Cleaning: Patients should be advised to read the Patient Information Leaflet carefully for cleaning instructions: The inhaler should be cleaned once a week. <ul> <li>Remove the mouthpiece cover.</li> <li>Do not remove the canister from the plastic casing.</li> <li>Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.</li> <li>Replace the mouthpiece cover in the correct orientation.</li> <li>Do not put the metal canister into water.</li> </ul> If a patient requires an AeroChamber Plus spacer device then they must be advised to read the instructions provided by the manufacturer to ensure they use it and clean and maintain it properly.
Route Of Administration: RESPIRATORY (INHALATION)
Indication Info: 4.1 Therapeutic indications This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform® inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: <ul> <li>For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. Or</li> <li>For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.</li> </ul> Flutiform® 50 microgram/5 microgram is indicated in adults, adolescents and children aged 5 years and above. Flutiform® 125 microgram/5 microgram is indicated in adults and adolescents aged 12 years and above. Flutiform® 250 microgram/10 microgram inhaler is indicated in adults only.
Contraindications: 4.3 Contraindications Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: R03AK07
Atc Item Name: formoterol and budesonide
Pharma Manufacturer Name: MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Active Ingredients

Fluticasone Propionate

125 mcg/actuation

Formoterol Fumarate Dihydrate

5 mcg/actuation

Fluticasone Propionate

125 mcg/actuation

Formoterol Fumarate Dihydrate

5 mcg/actuation

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 19, 2014

Approval ID

677780d80a0cd566

Type

Therapeutic

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