- Approval Id
- 139341f6a03cf314
- Drug Name
- SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM
- Product Name
- SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM
- Approval Number
- SIN15885P
- Approval Date
- 2020-02-18
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see 4.2).<br>
Two puffs from the Respimat inhaler comprise one medicinal dose.<br>
The recommended dose for adults is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.</p>
<p>The recommended dose should not be exceeded.</p>
<p>In the treatment of asthma, the full benefit will be apparent after several doses of the medicinal product.</p>
<p><u>Special populations</u></p>
<p>Geriatric patients can use tiotropium bromide at the recommended dose.<br>
Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see 4.4 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population</u></p>
<p><u>COPD</u></p>
<p>SPIRIVA RESPIMAT re-usable is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy (see 5.1 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Asthma</u></p>
<p>In asthma, the recommended dosage of tiotropium using the SPIRIVA RESPIMAT re-usable in patients 6 to 17 years of age is 5 micrograms. This is administered as two puffs once daily from the RESPIMAT inhaler, at the same time each day (see RESPIMAT inhaler Handling Instructions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>SPIRIVA RESPIMAT re-usable has not been studied in children less than 1 year old.</p>
<p><u>Method of administration</u></p>
<p>To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professionals.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><u>COPD</u></p>
<p>SPIRIVA RESPIMAT re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).</p>
<p><u>Asthma</u></p>
<p>SPIRIVA RESPIMAT re-usable is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>SPIRIVA RESPIMAT re-usable is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients (see 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- R03BB04
- Atc Item Name
- tiotropium bromide
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
