Modelo de texto de bula profissional de saúde Avamys ® 1 LEIA ESTA BULA ATENTAMENTE ANTES DE INICIAR O TRATAMENTO. I) IDENTIFICAÇÃO DO MEDICAMENTO Avamys ® furoato de fluticasona APRESENTAÇÕES Spray nasal com 120 doses. USO INTRANASAL USO ADULTO E PEDIÁTRICO (ACIMA DE 2 ANOS) COMPOSIÇÃO Cada dose contém: furoato de fluticasona ................................................. 27,5 mcg excipientes* ............................................................... q.s.p. ......................................................... 1 dose *excipientes: glicose anidra, celulose dispersível, polissorbato 80, solução de cloreto de benzalcônio, edetato dissódico e água purificada. II) INFORMAÇÕES TÉCNICAS AOS PROFISSIONAIS DE SAÚDE 1. INDICAÇÕES Adultos e /adolescentes (a partir de 12 anos de idade) Tratamento dos sintomas nasais (rinorreia, congestão nasal, prurido e espirros) e dos sintomas oculares (prurido/ardência, lacrimejamento e vermelhidão) da rinite alérgica sazonal. Tratamento dos sintomas nasais (rinorreia, congestão nasal, prurido e espirros) da rinite alérgica perene. Crianças (2 a 11 anos) Tratamento dos sintomas nasais (rinorreia, congestão nasal, prurido e espirros) da rinite alérgica sazonal e perene. 2. RESULTADOS DE EFICÁCIA Rinite alérgica sazonal em adultos e adolescentes Uma dose de Avamys ® Spray Nasal de 110 mcg uma vez ao dia resultou em melhora significativa, em comparação com placebo, das pontuações totais de sintomas nasais pré-dose (rTNSS e iTNSS, que consistem em rinorreia, congestão nasal, espirros e prurido) subjetivos diários e objetivos e das pontuações totais de sintomas oculares (rTOSS, que consistem em prurido/ardência, lacrimejamento e vermelhidão) subjetivos diários e objetivos em comparação com placebo (ver tabela abaixo). Os sintomas subjetivos representam a forma como o paciente se sentiu durante as 12 horas anteriores e os sintomas objetivos a forma como se sentiu na ocasião da avaliação. A melhora dos sintomas nasais e oculares se manteve ao longo de todo o período de 24 horas decorrido após a administração de uma dose diária. Rinite alérgica sazonal: desfechos primários e secundários Estudo Desfecho primário: rTNSS diárias Desfecho secundário: rTOSS diárias Diferença média de QM Valor p (IC de 95%) Diferença média de QM Valor p (IC de 95%) FFR20001 -2,012 <0,001 (-2,58 a -1,44) - - FFR30003 -0,777 0,003 (-1,28 a 0,27) -0,546 0,008 (-0,95 a 0,14) FFR103184 -1,757 <0,001 (-2,28 a 1,23) -0,741 <0,001 (-1,14 a 0,34) FFR104861 -1,473 <0,001 (-2,01 a 0,94) -0,600 0,004 (-1,01 a 0,19) rTNSS = pontuações totais de sintomas nasais subjetivos rTOSS = pontuações totais de sintomas oculares subjetivos QM = quadrados mínimos diferença média de QM = alteração média de QM em relação à avaliação inicial do fármaco ativo menos a alteração média de QM em relação à avaliação inicial do placebo IC = intervalo de confiança A distribuição da percepção dos pacientes sobre a resposta global ao tratamento (segundo uma escala de 7 pontos que varia de significativamente melhor a significativamente pior) favoreceu Avamys ® Spray Nasal 110 mcg em relação ao placebo, com diferença de tratamento estatisticamente significativa. Observou-se o início da ação já a partir de 8 horas após a primeira administração em dois estudos. Uma melhora significativa dos sintomas foi registrada nas primeiras 24 horas em quatro estudos e continuou a aumentar ao longo de vários dias. A qualidade de vida dos pacientes, avaliada pelo Questionário de Qualidade de Vida Relativa à Rinoconjuntivite (RQLQ), melhorou significativamente em relação à avaliação inicial com Avamys ® Spray Nasal em comparação com placebo (diferença mínima relevante em todos os estudos = melhora de pelo menos -0,5 em relação ao placebo; diferença entre os tratamentos de -0,690; p<0,001; IC de 95%: -0,84 a -0,54).
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L A N D M A R K
Make your Someday, Now
PANTRY
TILTINGKING
BED
W/DPREP
OHC
OHC OHC
OHC
OHC
OH
C
AWNING
LM NEWPORT
W/D
PREP
LINEN
TILTINGKING
BED
LM LAFAYETTE
AWNING AWNING
OHC
OH
C
OH
C
KINGBED
70” x 80”
PANTRY
TILTINGKING
BED
AWNING
OHC
OH
C
OHCO
HC
OHCOHC LM CONCORD
PANTRY W/D PREP
SIDE BY SIDE
TILTINGKING
BEDOHC
OHC
OH
C
AWNING
W/D PREPOR
WARDROBE
W/D PREPOR
WARDROBE
LM OSHKOSH
MODEL GVWR AXLES GAWR DRY UVW CCC HITCH LENGTH
OSHKOSH 18,000 8,000 14,527 3,421 2,900 39' 2"
CONCORD 18,000 8,000 14,677 3,271 2,925 42' 7"
NEWPORT 18,000 8,000 14,843 3,105 3,048 42' 6"
LAFAYETTE 18,000 8,000 15,251 2,697 3,918 42' 10"
DAYTONA 18,000 8,000 15,089 2,859 3,115 42' 6"
Floorplans
W/DPREP
PAN
TRY
TILTINGKING
BED
IN-WALLOVEN
OHC
OH
C
OHC LM DAYTONAAWNING
What sets the Landmark apart in the luxury fifth wheel market and beyond?
• Landmark is Heartland’s only brand with a comprehensive two year, full time friendly warranty.
• 3 choices of triple-cut-and-buffed full body paint• 3 standard air conditioners for 45,000 total BTU cooling power,
all able to run simultaneously• True walk-in closet with deep shelves (4 models)• Power reclining sofa with flip down center section for drink holders/lunch tray/
USB/110V power• Strut-assisted entry step• Wave pattern headboard with framed in LEDs• Multi-plex lighting with backlit, labeled switches and dimmers• Curved slide out fascia lit from floor to ceiling • Backlit Burl pattern kitchen backsplash panel• Power inclining bed lift mechanism (adds 20˝ of walkable floor space!)• Whole house energy management system • 17.5˝ H-range tires and 8,000lb Dexter axles with shocks and 3 3/8˝ drum brakes• Window sills and true-privacy trim on living room windows for total blackout with
roller shades• Surge guard whole-house electrical protection• Double exterior LED-lit awnings standard• Disc brake option• Dishwasher option• Stainless steel farmhouse sink with apron and cutting board
Options• Yeti Extreme Cold Weather Package• Heat Pump on Main and/or 2nd A/C• Fantastic Fan Bath• Stackable Washer/Dryer• Dishwasher (Newport, Daytona, Oshkosh only)• Disc Brakes• 5.5KW Onan LP Generator • Slide Awning Package (3, 4 or 5 slides)• Alumi-Guard wrapped awnings• 40’’ Exterior TV
CORE PACKAGE:• Multi-Plex Lighting System
with Touchscreen & App• 8000# Dexter Axles/Springs & Hubs with
Aluminum Wheels & 17.5 H Range Tires• Electric Power Cord Reel• MorRyde LRE 4000 Suspension• Surge Protection• 1000 Watt Invertor• 80 amp Convertor• 50 Amp Service• Sofa Tables with power outlets• Backlit Backsplash• Low Level Nightlights on 2 Three-Way
Switches• First Alert Safe• High Rise Coffee Table• 2.4 cu. ft. Stainless Steel Oven
and 3-Burner Stove• Adjustable Bedroom Reading Lights• Zero-G Entry Step• Power Tilt Bed with King Mattress• Tile Look Shower with Teak Seat• Hardwood Interior Steps
HOME PACKAGE:• Frameless Dual Pane Windows• MorRyde Pin Box• Dyson Cordless Vac• 5100 BTU Fireplace/Heater• Edge Lit Solid Surface Countertops• Residential Refer• Full-Extension Ball Bearing Drawer Guides• Washer Dryer Prep• Farmhouse Stainless Single Basin Kitchen
Sink with Cutting Board & Apron• 13 Gal Trash Can• Silverware Drawer• Convection Microwave• 55’’ Living Room LED TV with Sound Bar• Independent Slide Switches• Solid Stained Maple Hardwood Cabinetry• 300W Solar System Prep• Backlit Fascia• Pre-Wire for Winegard Traveler Satellite• LED Lighting• Generator Prep• Solid Surface Molded Bath Sinks
AWAY PACKAGE:• Universal Docking Center with Water Filter• 3 Way Water Pump Switch• Ceiling Fan with Wooden Shroud
(N/A Lafayette or Phoenix)• 30lb LP Tanks• High Gloss Fiberglass• Dual Satellite Prep• Dual Battery Hookup• Aluminum Wheels• Battery Disconnect• 6-Point Automatic Hydraulic Level Up• Aluminum Framed Laminated Floor• Radius Slam Latch Baggage Doors• 45K BTU Whisper Quiet A/C System• MCD Roller Shades• Bedroom TV• 8-USB Outlets• Energy Management System• Double Power Awnings• Power Theatre Seating
with Heat and Massage• Euro Entry Door Latch
Exclusive List
Standards
Heartland Recreational Vehicles2831 Dexter Drive
Elkhart, Indiana 46514574-262-5992
Your Authorized Heartland Dealer:
Product information is as accurate as possible as of the date of publication of this brochure. Due to Heartlands commitment to continuous product improvement - floorplans, materials, components, features, measurements, specifications, options, etc. are subject to change at any time without notice or obligation. In certain conditions some additional equipment may be needed. Photos may show optional equipment or props used for photography purposes only. Heartland has listed the approximate base weight of the trailer without the option equipment included. Option equipment will impact the weight of the trailer. Please locate the weight sticker attached to the trailer you are considering for the most accurate trailer weight. Tow Vehicle Caution: Owners of Heartland recreational vehicles are solely responsible for the selection and proper use of tow vehicles. All customers should consult with a motor vehicle manufacturer or their dealer concerning the purchase and use of suitable tow vehicles for Heartland products. Heartland disclaims any liability or damages suffered as a result of the selection, operation, use or misuse of a tow vehicle. Heartland’s limited warranty does not cover damage to the recreational vehicle or the tow vehicle as a result of the selection of the tow vehicle. 30,000 Litho 9/18
www.HEARTLANDRVS.com
FULL TIME LUXURY LIFETIME VALUE
DON’T UNDERESTIMATE CUSTOMER SERVICE & PERSONAL CARE!For Canadian Residents: If you purchase an RV out-of-country, there are additional fees, taxes and inspections that must be met before bringing your product home. Your local Canadian dealers are experts in these provisions.
Community. Convenience. Close-to-home.
Where you purchase your recreational vehicle is ultimately your decision but Heartland urges you to consider buying at your local dealer. Dealers are part of your community, providing jobs and contributing to your local economy. These dealers are under obligation to provide warranty service for products they sell, but are not legally required to service products purchased from other dealers. At some point, you may need to return to the dealer you buy from - why not stay close to home? After all, home is where your Heartland is!
BENEFITS OF PURCHASING YOUR RV LOCALLY:
• You enjoy valuable relationship building with Dealer Representatives, close to your home, who will explain the features and benefits of the product.
• You receive a full product orientation prior to delivery, which includes hands-on directions for many of the coach’s systems and functions. You are also introduced to the Dealership’s Service/Parts/Warranty personnel who are at the ready to help you with any issues you may encounter, now and in the future.
• You enjoy customer PRIORITY. Dealerships generally service their purchasing customers first - others may experience long delays and miss opportunities to use their RV. What is it worth for you to have a dealership’s full attention and motivation to satisfy you when you need service – in a timely manner?
• Valuable TAX dollars and jobs stay in YOUR community which pays for your roads, schools, police and fire departments.
• HEARTLAND ADVANTAGE
•
GR
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UFACTURING PROCESSES
TOP
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E
TOP
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WING PERFORMANC
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TIM
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Annu
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A Dealer Satisfaction IndexAnnu
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A Dealer Satisfaction Index
Annual RVDA DEALERSATISFACTION INDEX
AWARD WINNER
•A
WARD WINNER
•4
Black & Creme Full Body Paint
Black & Red Full Body Paint
Black & Silver Full Body Paint
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