UTIBRON NEOHALER- indacaterol maleate and glycopyrrolate capsule
Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Taarifa za kipeperushi
(PIL)
16-12-2018
Tabia za bidhaa
(SPC)
31-05-2019
Viambatanisho vya kazi:
INDACATEROL MALEATE (UNII: 2JEC1ITX7R) (INDACATEROL - UNII:8OR09251MQ), GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Inapatikana kutoka:
Sunovion Pharmaceuticals Inc.
INN (Jina la Kimataifa):
INDACATEROL MALEATE
Tungo:
INDACATEROL 27.5 ug
Njia ya uendeshaji:
RESPIRATORY (INHALATION)
Dawa ya aina:
PRESCRIPTION DRUG
Matibabu dalili:
UTIBRON® NEOHALER® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use: UTIBRON NEOHALER is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)] . The safety and effectiveness of UTIBRON in asthma have not been established. Use of a LABA, including UTIBRON NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1)] . UTIBRON NEOHALER is not indicated for the treatment of asthma. UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see Warnings and Precautions (5.5)] . Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies with UTIBRON
Bidhaa muhtasari:
How Supplied UTIBRON NEOHALER contains UTIBRON (indacaterol/glycopyrrolate, (27.5 mcg, 15.6 mcg) inhalation powder) in hypromellose (HPMC) capsule with yellow transparent cap and uncolored transparent body, with capsules packaged in aluminum blister cards, one NEOHALER device, and an FDA-approved Patient Information. Unit Dose (blister pack), Box of 60 (10 blister cards with 6 yellow transparent capsules each) NDC 63402-681-60 Unit Dose (blister pack), Box of 6 (1 blister card with 6 yellow transparent capsules each) NDC 63402-681-06 The NEOHALER device consists of a white protective cap and a base with mouthpiece, capsule chamber and 2 yellow push buttons. Storage and Handling Store in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children.
Idhini hali ya:
New Drug Application
Taarifa za kipeperushi
These highlights do not include all the information
needed to use UTIBRON NEOHALER safely and effectively. See full
prescribing information for UTIBRON NEOHALER.UTIBRON
NEOHALER</span><span class="Bold"><span
class="Sup">®</span></span> <br /> <span class="Bold">(yoo-
TEE-bron)</span> <br /> <span class="Bold">(indacaterol and
glycopyrrolate)</span> <br /> <span class="Bold">inhalation
powder, for oral inhalation use</span></td>
</tr>
<tr>
<td class="Botrule Lrule Rrule" align="left" colspan="3"
valign="top"><span class="Bold">Important: Do not swallow UTIBRON
capsules. UTIBRON capsules are used only with the NEOHALER
inhaler that comes with UTIBRON NEOHALER. Do not place a capsule
in the mouthpiece of the NEOHALER inhaler.</span> <br /> <span
class="Bold">Read the Medication Guide that comes with UTIBRON
NEOHALER before you start using it and each time you get a
refill. There may be new information. This Medication Guide does
not take the place of talking to your healthcare provider about
your medical condition or treatment.</span></td>
</tr>
<tr>
<td class="Botrule Lrule Rrule" align="left" colspan="3"
valign="top"> <p class="First"> <a name="p02"></a><span
class="Bold">What is the most important information I should know
about UTIBRON NEOHALER?</span> </p> <p> <br /> <span
class="Bold">UTIBRON NEOHALER has been approved for Chronic
Obstructive Pulmonary Disease (COPD). UTIBRON NEOHALER is NOT
indicated for use in asthma.</span> <br /> <span
class="Bold">UTIBRON NEOHALER may cause serious side effects,
including:</span> <br /> </p>
<ul class="Disc">
<li> <span class="Bold">People with asthma who take long-
acting beta</span><span class="</span>
<a class="h6 col-12 text-left" style="" href="/sw/view/3238637/e74643c0ffa0bd8841e3f56e4bcde45c/leaflet" title="Tabia za bidhaa" target="_blank" rel="nofollow, noindex">
<u>Soma hati kamili</u>
</a>
</pre>
</div>
<div class="col-12 offset-md-1 mt-2">
<h3>Tabia za bidhaa</h3>
<pre style="white-space: pre-line;">
<span>UTIBRON NEOHALER- INDACATEROL MALEATE AND GLYCOPYRROLATE CAPSULE
SUNOVION PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UTIBRON NEOHALER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR UTIBRON NEOHALER.
UTIBRON NEOHALER (INDACATEROL AND GLYCOPYRROLATE) INHALATION POWDER,
FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Box Warning,
Removed 05/2019
Contraindications, revised (4)
05/2019
Warnings and Precautions, revised
05/2019
Serious Asthma-Related Events – Hospitalizations, Intubations, Death
(5.1)
05/2019
INDICATIONS AND USAGE
UTIBRON NEOHALER is a combination of indacaterol, a long-acting beta
-adrenergic agonist (LABA), and glycopyrrolate,
an anticholinergic, indicated for the long-term, maintenance treatment
of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD). (1)
Limitations of Use: Not indicated for the relief of acute bronchospasm
or for the treatment of asthma. (1, 5.1, 5.2)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY. DO NOT SWALLOW UTIBRON CAPSULES. ONLY USE
UTIBRON CAPSULES WITH THE
NEOHALER DEVICE. (2)
Maintenance treatment of COPD: The inhalation of the powder contents
of one UTIBRON capsule twice-daily. (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: UTIBRON capsules contain 27.5 mcg of indacaterol
and 15.6 mcg glycopyrrolate inhalation powder
for use with the NEOHALER device. (3)
CONTRAINDICATIONS
Use of a LABA, including UTIBRON NEOHALER, without an inhaled
corticosteroid is contraindicated in patients with
asthma. (4)
History of known hypersensitivity to indacaterol, glycopyrrolate, or
to any of the ingredients. (4, 5.5)
WARNINGS AND PRECAUTIONS
LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the risk of serious asthma-related
events (5.1)
Do not initiate in acutely deteriorating COPD or to treat acute
symptoms. (5.2)
Do not use in combination with an additional medicine containing LABA
because of </span>
<a class="h6 col-12 text-left" style="" href="/sw/view/2809923/ec5a53f8b465083a979fbcc793172aba/leaflet" title="Tabia za bidhaa" target="_blank" rel="nofollow, noindex">
<u>Soma hati kamili</u>
</a>
</pre>
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