ORALAIR- anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratens

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE TOP - UNII:S7PW24BX20, PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG), ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y), DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P), POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T), LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0)

Dostopno od:

CENEXI HSC

Terapevtske indikacije:

ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms. ORALAIR is contraindicated in patients with: - Severe, unstable or uncontrolled asthma - History of any severe systemic allergic reaction - History of any severe local reaction to sublingual allergen immunotherapy - A history of eosinophilic esophagitis - Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product [ See Description (11) ] Risk Summary All pregnancies have a risk of birth defect, loss, or other a

Povzetek izdelek:

ORALAIR is available as a sublingual tablet equivalent to 100 IR and 300 IR of five grass mixed pollens allergen extract. Children and Adolescents Sample Kit (5 to 17 years of age) One box of the 100 IR Starter Pack Two boxes of the 300 IR Sample Packs One box of 300 IR Starter Pack Two boxes of 300 IR Sample Packs Children and Adolescents Starter Pack (5 to 17 years of age) 1 blister pack of three 100 IR tablets 1 blister pack of three 300 IR tablets 1 blister pack of three 300 IR tablets 1 blister pack of thirty 300 IR tablets Storage: Store at controlled room temperature (20°C-25°C/68°F-77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

Status dovoljenje:

Biologic Licensing Application

Navodilo za uporabo

pratense pollen, and poa pratensis pollen
ORALAIR 300 IR- anthoxanthum odoratum pollen, dactylis glomerata
pollen, lolium perenne pollen,
phleum pratense pollen, and poa pratensis pollen tablet, orally
disintegrating
CENEXI HSC
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MEDICATION GUIDE
ORALAIR ® (OR-AL-AIR): (Sweet Vernal, Orchard, Perennial Rye,
Timothy, and Kentucky Blue Grass
Mixed Pollens Allergen Extract)
Carefully read this Medication Guide before you or your child start
taking ORALAIR and each time you get
a refill. This Medication Guide does not take the place of talking to
your doctor about your medical condition
or treatment. Talk with your doctor or pharmacist if there is
something you do not understand or you want to
learn more about ORALAIR.
What is the Most Important Information I Should Know about ORALAIR?
ORALAIR can cause severe allergic reactions that may be
life-threatening. Symptoms of allergic reactions to
ORALAIR include:
•
Trouble breathing
•
Throat tightness or swelling
•
Trouble swallowing or speaking
•
Dizziness or fainting
•
Rapid or weak heartbeat
•
Severe stomach cramps or pain, vomiting, or diarrhea
•
Severe flushing or itching of the skin
If any of these symptoms occur, stop taking ORALAIR and immediately
seek medical care.
For home administration of ORALAIR, your doctor should prescribe
auto-injectable epinephrine for you to
keep at home for treating a severe reaction, should one occur. Your
doctor will train and instruct you on the
proper use of auto-injectable epinephrine.
What is ORALAIR
ORALAIR is a prescription medicine used for sublingual (under the
tongue) immunotherapy prescribed to
treat sneezing, runny or itchy nose, nasal congestion or itchy and
watery eyes due to allergy to these grass
pollens. ORALAIR may be prescribed for persons 5 to 65 years of age
whose doctor has confirmed are
allergic to any of the grass pollens contained in ORALAIR.
ORALAIR is taken for about four months before the expected start of
the grass pollen season and is
continued throughout the grass pollen season.
OR

Lastnosti izdelka

ORALAIR- ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN,
LOLIUM
PERENNE POLLEN, PHELUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN
ORALAIR 300 IR- ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA
POLLEN,
LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS
POLLEN TABLET, ORALLY DISINTEGRATING
CENEXI HSC
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ORALAIR® (SWEET VERNAL, ORCHARD, PERENNIAL RYE, TIMOTHY, AND KENTUCKY
BLUE GRASS MIXED POLLENS ALLERGEN EXTRACT)
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORALAIR
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORALAIR.
TABLET FOR SUBLINGUAL USE
INITIAL U.S. APPROVAL: 2014
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ORALAIR safely and
effectively. See full prescribing information for ORALAIR.
ORALAIR
(Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue
Grass
Mixed Pollens Allergen Extract)
Tablet for Sublingual Use
Initial U.S. Approval: 2014
WARNING: SEVERE ALLERGIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ORALAIR CAN CAUSE LIFE-THREATENING ALLERGIC REACTIONS SUCH AS
ANAPHYLAXIS
AND SEVERE LARYNGOPHARYNGEAL EDEMA. (5.1)
DO NOT ADMINISTER ORALAIR TO PATIENTS WITH SEVERE, UNSTABLE OR
UNCONTROLLED ASTHMA. (4)
OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING THE
INITIAL
DOSE. (5.1)
PRESCRIBE AUTO-INJECTABLE EPINEPHRINE, INSTRUCT AND TRAIN PATIENTS ON
ITS
APPROPRIATE USE, AND INSTRUCT PATIENTS TO SEEK IMMEDIATE MEDICAL CARE
UPON ITS USE. (5.2)
ORALAIR MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN UNDERLYING
MEDICAL
CONDITIONS THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SERIOUS ALLERGIC
REACTION. (5.2)
ORALAIR MAY NOT BE SUITABLE FOR PATIENTS WHO MAY BE UNRESPONSIVE TO
EPINEPHRINE OR INHALED BRONCHODILATORS, SUCH AS THOSE TAKING BETA-
BLOCKERS. (5.2)
RECENT MAJOR CHANGES
®
INDICATIONS AND USAGE (1)
11/2018
DOSAGE AND ADMINISTRATION (2.1)
11/2018
INDICATIONS AND USAGE
ORALAIR is an allergen extract indicated as immunotherapy for the
tr