SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM 2.5 MICROGRAM

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Olodaterol hydrochloride eqv olodaterol; Tiotropium bromide monohydrate eqv tiotropium

Saatavilla:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC-koodi:

R03AL06

Lääkemuoto:

SOLUTION

Koostumus:

Olodaterol hydrochloride eqv olodaterol 0.0025 mg/actuation; Tiotropium bromide monohydrate eqv tiotropium 0.0025 mg/actuation

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

Prescription Only

Valmistaja:

Boehringer Ingelheim Pharma GmbH & Co. KG

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2020-02-25

Valmisteyhteenveto

1.
NAME OF THE MEDICINAL PRODUCT
Spiolto® Respimat® re-usable solution for inhalation 2.5 microgram /
2.5 microgram
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The SPIOLTO RESPIMAT re-usable is a soft mist inhaler delivering
tiotropium + olodaterol inhalation
solution.
The delivered dose is 2.5 microgram tiotropium and 2.5 microgram
olodaterol per puff (2 puffs comprise
one medicinal dose) and is equivalent to 3.124 microgram tiotropium
bromide monohydrate and 2.7
microgram olodaterol hydrochloride.
(INN = tiotropium bromide)
(INN= olodaterol)
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPIOLTO RESPIMAT re-usable is indicated as a maintenance
bronchodilator treatment to relieve
symptoms in adult patients with chronic obstructive pulmonary disease
(COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose for adults is 5 microgram tiotropium and 5
microgram olodaterol given as two
puffs from the Respimat inhaler once daily at the same time of the day
(see Instructions for Use).
Elderly
Elderly patients can use SPIOLTO RESPIMAT re-usable at the recommended
dose.
Hepatic impairment and renal impairment
SPIOLTO RESPIMAT re-usable contains tiotropium which is a
predominantly renally excreted drug and
olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment
Patients with mild and moderate hepatic impairment can use SPIOLTO
RESPIMAT re-usable at the
recommended dose.
There are no data available for use of olodaterol in patients with
severe hepatic impairment.
abcd
Renal impairment
Renally impaired patients can use SPIOLTO RESPIMAT re-usable at the
recommended dose.
SPIOLTO RESPIMAT re-usable contains tiotropium, which is a
predominantly renally excreted drug. For
patients with moderate to severe impairment (creatinine clearance ≤
50 ml/min, see Specia