BROVANA- arformoterol tartrate solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

arformoterol tartrate (UNII: 5P8VJ2I235) (arformoterol - UNII:F91H02EBWT)

から入手可能:

Sumitomo Pharma America, Inc.

INN（国際名）:

arformoterol tartrate

構図:

arformoterol 15 ug in 2 mL

投与経路:

RESPIRATORY (INHALATION)

処方タイプ:

PRESCRIPTION DRUG

適応症:

BROVANA (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA Inhalation Solution is for use by nebulization only. BROVANA Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions (5.2) ]. BROVANA Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of BROVANA Inhalation Solution in asthma have not been established. BROVANA Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a LABA, including BROVANA Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions (5) ]. BROVANA Inhalation Solution is not ind

製品概要:

BROVANA (arformoterol tartrate) Inhalation Solution is supplied in a single strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) as 2 mL of a sterile solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. BROVANA Inhalation Solution is available in a shelf-carton containing 30 or 60 unit-dose vials. NDC 63402-911-30: carton of 30 individually pouched unit-dose vials. NDC 63402-911-64: carton of 60 unit-dose vials (15×4 unit-dose vial pouches). Storage and Handling Store BROVANA Inhalation Solution in the protective foil pouch under refrigeration at 36°-46°F (2°-8°C). Protect from light and excessive heat. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away. Discard any unit-dose vial if the solution is not colorless. Unopened foil pouches of BROVANA Inhalation Solution can also be stored at room temperature 68°-77°F (20°-25°C) for up to 6 weeks. If stored at room temperature, discard if not used after 6 weeks or if past the expiration date, whichever is sooner.

認証ステータス:

New Drug Application

情報リーフレット

Sunovion Pharmaceuticals Inc.
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MEDICATION GUIDE
BROVANA® [Brō vă´-nah]
(arformoterol tartrate) Inhalation Solution
BROVANA is only for use with a nebulizer.
Read the Medication Guide that comes with BROVANA 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.
What is the most important information I should know about BROVANA?
BROVANA can cause serious side effects, including:
•
People with asthma, who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as
BROVANA, have an increased risk of death from asthma problems.
•
It is not known if LABA medicines, such as BROVANA, increase the risk
of death in people with
chronic obstructive pulmonary disease (COPD).
•
Get emergency medical care if:
•
breathing problems worsen quickly
•
you use your rescue inhaler medicine, but it does not relieve your
breathing problems
What is BROVANA?
BROVANA is used long term, 2 times each day (morning and evening), in
controlling symptoms of
chronic obstructive pulmonary disease (COPD) in adults with COPD.
BROVANA is only for use with a nebulizer.
LABA medicines such as BROVANA help the muscles around the airways in
your lungs stay relaxed to
prevent symptoms, such as wheezing, cough, chest tightness, and
shortness of breath.
BROVANA should not be used in children. It is not known if BROVANA is
safe and effective in
children.
It is not known if BROVANA is safe and effective in people with
asthma.
Who should not use BROVANA?
Do not use BROVANA if you:
•
have had a serious allergic reaction to arformoterol, formoterol, or
any of the ingredients in
BROVANA. Ask your healthcare provider if you are not sure. See the end
of this Medication
Guide for a complete list of ingredients in BROVANA.
•
have asthma without using a long-term asthma control medicine.
What should I tell my healthcare provider before using BROVANA?
Tell your healthcare pr

製品の特徴

BROVANA- ARFORMOTEROL TARTRATE SOLUTION
SUMITOMO PHARMA AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BROVANA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BROVANA.
BROVANA (ARFORMOTEROL TARTRATE) INHALATION SOLUTION
INITIAL U.S. APPROVAL: 2006
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)
INDICATIONS AND USAGE
BROVANA Inhalation Solution is a long-acting beta -adrenergic agonist
(beta -agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the
maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary
disease (COPD), including chronic
bronchitis and emphysema. (1.1)
Important limitations of use:
BROVANA Inhalation Solution is not indicated to treat acute
deteriorations of chronic obstructive
pulmonary disease. (1.2, 5.2)
BROVANA Inhalation Solution is not indicated to treat asthma. (1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
A total daily dose of greater than 30 mcg is not recommended. (2)
One 15 mcg/2 mL vial every 12 hours. (2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor.
(2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization): 15 mcg/2 mL
solution (3)
CONTRAINDICATIONS
BROVANA Inhalation Solution is contraindicated in patients with a
history of hypersensitivity to
arformoterol, racemic formoterol or to any other components of this
product. (4)
Use of a LABA, including BROVANA Inhalation Solution, without an
inhaled corticosteroid is
contraindicated in patients with asthma. (4)
WARNINGS AND PRECAUTIONS
LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the ri