Land: Israel
Språk: engelska
Källa: Ministry of Health
GLYCOPYRRONIUM AS BROMIDE; INDACATEROL AS MALEATE
NOVARTIS ISRAEL LTD
R03AC18
INHALATION POWDER HARD CAPSULES
INDACATEROL AS MALEATE 110 MCG; GLYCOPYRRONIUM AS BROMIDE 50 MCG
INHALATION
Required
SIEGFRIED BARBERA, S.L., SPAIN
INDACATEROL
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
2019-01-31
ULT API MAY23 V 2.1 REF EU SmPC 18Nov2020 Business Use Only 1. NAME OF THE MEDICINAL PRODUCT Ultibro ® Breezhaler ® 110/50 mcg Inhalation powder hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.5mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Capsules with transparent yellow cap and natural transparent body containing a white to practically white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ultibro Breezhaler 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 Posology The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler. Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day. Special populations _Elderly population _ Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). _Renal impairment _ Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal i Läs hela dokumentet
ULT API JAN21 V 2.0 REF EU SmPC 18Nov2020 Business Use Only 1. NAME OF THE MEDICINAL PRODUCT Ultibro ® Breezhaler ® 110/50 mcg Inhalation powder hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.5mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Capsules with transparent yellow cap and natural transparent body containing a white to practically white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ultibro Breezhaler 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 Posology The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler. Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day. Special populations _Elderly population _ Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). ULT API JAN21 V 2.0 REF EU SmPC 18Nov2020 Business Use Only _Renal impairment _ Ultibro Breezhaler can be used at the recommended dose in patients with mild t Läs hela dokumentet