4.6       Fertility, pregnancy and lactation. This is an anti-inflammatory steroid medicine, which safely helps to treat the symptoms of allergic rhinitis (an inflammation of the inside of the nose caused by an allergy, such as with hay fever). Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended. The device should be cleaned after each use and the cap replaced. Do not use extra dose to make up for a missed dose. Elderly Patients: No dose adjustment is required in this population (see section 5.2). It is required before any medicine is allowed on the market in Europe. Children under 6 years of age: The experience in children under the age of 6 years is limited (see section 5.1 and 5.2). Please consult your physician or pharmacist or product package for this information. Added the following undesirable effects with the frequency ‘not known’: Regarding the undesirable effect ‘Growth retardation’ the following explanatory note was added. Please consult your physician or pharmacist or product package for more information. The following new sub-headings were added ‘Systemic corticosteroid effects’, ‘Eye disorders’, ‘Growth retardation’, ‘Patients on ritonavir’, and ‘Patients with hepatic impairment’, and the relevant paragraphs have been moved under these. As with other intranasal corticosteroids, physicians should be alert to potential systemic steroid effects including ocular changes (see Pharmacodynamic properties). Added the sub-heading ‘Interaction with CYP3A4 inhibitors’; no changes to text. Avamys 27.5 micrograms/spray, nasal spray suspension - Patient Information Leaflet (PIL) by GlaxoSmithKline UK ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed, Augmentin 250 mg/125 mg film-coated tablets, Augmentin 500mg/125mg Film-coated Tablets, Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension, Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension, Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion, Betnovate Scalp Application 0.1% w/v Cutaneous Solution, Bexsero, suspension for injection in pre-filled syringe, Meningococcal group-B vaccine (rDNA, component, adsorbed), Diphtheria, Tetanus and Pertussis vaccine, Change to section 2 - what you need to know - warnings and precautions, Change to section 6 - marketing authorisation holder, Change to section 2 - Qualitative and quantitative composition, Change to section 4.2 - Posology and method of administration, Change to section 4.4 - Special warnings and precautions for use, Change to section 4.5 - Interaction with other medicinal products and other forms of interaction, Change to section 4.6 - Pregnancy and lactation, Change to Section 4.8 – Undesirable effects - how to report a side effect, Change to section 5.1 - Pharmacodynamic properties, Change to section 5.2 - Pharmacokinetic properties, Change to section 6.5 - Nature and contents of container, Change to section 10 - Date of revision of the text, Change to section 4.8 - Undesirable effects, Change to section 4 - possible side effects, Change to section 4 - how to report a side effect, Change to section 7 - Marketing authorisation holder, Change to section 2 - use in children and adolescents, Change to section 2 - interactions with other medicines, food or drink, Change to warnings or special precautions for use, Change to section 6.1 - List of excipients, Change to section 1 - Name of medicinal product, Change to section 4.1 - Therapeutic indications, Change to section 4.3 - Contraindications, Change to section 4.7 - Effects on ability to drive and use machines, Change to section 6.4 - Special precautions for storage. 4.4       Special warnings and precautions for use. Avamys (fluticasone furoate) nasal spray belongs to a class of medications known as corticosteroids. Minor editorial updates to sections 1, 2, 4.2, 4.3, 4.9, 5.1 and 5.2. The generic name for Avamys is fluticasone furoate nasal spray. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had. SmPC section 4.5: text updated to incorporate PRAC recommendations for the interaction of corticosteroids with cobicistat into the Avamys labelling. Added the description ‘nasal preparations’ to the Pharmacotherapeutic group, 6.4       Special precautions for storage, 6.5       Nature and contents of container. For each purchase they make, you get 20% off (upto $10) on your next purchase. Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. Accessed January 25, 2021. https://www.tabletwise.net/avamys-nasal-spray. Some medicines need to be tapered or cannot be stopped immediately because of rebound effects. Adults and Adolescents (12 years and over). For full therapeutic benefit regular, scheduled usage is recommended. There are no data in patients with severe hepatic impairment (see section 4.4 and 5.2). : No dose adjustment is required in mild to moderate hepatic impairment. Seretide Accuhaler 50/250 60's. Avamys nasal spray contains 27.5 micrograms of fluticasone furoate per spray. If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate. In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks). Please consult with your doctor for case-specific recommendations. Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value. Instructions This product is to be sprayed into the nostrils. Avamys Nasal Spray is a white suspension of micronised fluticasone furoate for topical administration to the nasal mucosa by means of a metering atomising spray pump. Avamys 27.5mcg nasal spray This medication contains an anti-inflammatory drug from the cortisone family (corticosteroid). 4.5       Interaction with other medicinal products and other forms of interaction. with updates to the SPC, PIL and Labelling regarding: Warnings & Precaution, Adverse Reactions, Clinical Studies and GPL: Possible side effects – Details: Addition of findings from a one-year paediatric growth study. Click to view Avamys … Avamys Nasal Sprayis available in the following packages and strengths. Childn 2-11 yr Initially 1 spray in each nostril once daily, may be increased to 2 sprays in each nostril once daily. Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Please consult with your doctor for recommendations specific to your body. Using your allergy nasal spray properly is important. Avamys nasal spray is for administration by the intranasal route only. avamys nasal spray 120 dose product id: 2590630. select a prescription. do not take by mouth. The mechanism by which Avamys works is by reducing the immune response of the eyes, ears, nose and throat. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently. Fluticasone What is Fluticasone for: This medication is a synthetic glucocorticoid, prescribed for preventing asthma and chronic obstructive pulmonary disease. The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms). ’ the following explanatory note was added, In a one-year clinical study assessing growth in pre-pubescent children receivi, ng 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared, Perennial Allergic Rhinitis in adults and adolescents, In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181). For adults and adolescents 12 years of age and older, the recommended dose is 2 sprays in each nostril once daily, preferably at the same time each day. 27.5 micrograms once daily, dose to be sprayed into each nostril, then increased if necessary to 55 micrograms once daily, dose to be sprayed into each nostril, reduced to 27.5 micrograms once daily, to be sprayed into each nostril, dose to be reduced once control achieved; use minimum effective dose. Avamys is a potent treatment option because it contains a corticosteroid, so it requires a prescription. Please consult your physician or pharmacist or refer to the product package. Blow your nose gently, if needed; Shake the nasal spray; Remove the cap by gently squeezing the sides of the cap; Tilt your head forward; Place the nozzle in one of your nostrils Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made. "Avamys Nasal Spray - Product - tabletwise.net" Tabletwise. Caution is advised when treating these patients. The bottle contains 120 sprays. In addition, consideration should be given to referring the patient to a paediatric specialist (see section 5.1). If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. Avamys Nasal Spray- Product - tabletwise.net. Avamys is used to treat the symptoms of allergic rhinitis. Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. The Summary of Product Characteristics (SPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. What other medicines doesAvamys Nasal Sprayinteract with? Retrieved January 25, 2021, from https://www.tabletwise.net/avamys-nasal-spray, "Avamys Nasal Spray - Product - tabletwise.net". S$7.00. Increases in posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or glaucoma. Avamys Nasal Sprayworks by controlling the biosynthesis of prostaglandins and leukotrienes. Interaction with CYP3A4 inhibitors’; no changes to text. Avamys 27,5 mikrogrammaa/suihke nenäsumute, suspensio. S$2.00 Related Products. Shake the nasal spray before use. Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5). The primary outcomes [time to increase in posterior subcapsular opacity (. Updated the description to remove details on the plastic device, and added the description of the volume of the product, to read: 14.2 ml suspension in a Type I amber bottle (glass) fitted with a metering spray pump. Veramyst Nasal Spray is available in generic form. Mean growth velocity over the 52-week treatment period was lower in the patients receiving fluticasone furoate (5.19 cm/year) compared to placebo (5.46 cm/year). The primary outcomes [time to increase in posterior subcapsular opacity (³0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; ³7 mmHg from baseline)] were not statistically significant between the two groups. Yleisiä ohjeita. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria. Avamys is a medicated nasal spray that is used to treat seasonal outdoor and ongoing indoor allergy symptoms. The mean treatment difference was -0.27 cm per year [95% CI -0.48 to -0.06]. Usually, the government's categorizes medicines that can be addictive as controlled substances. Indication updated to specify minimum age of 6 years (previously 11 years), i.e. Buy Avamys Nasal Spray Suspension Online. 0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between the two groups. Therefore close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts. Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over. Under the subheading ‘Perennial Allergic Rhinitis in adults and adolescents’, the following was added: In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181). The bottle is in an off-white plastic casing with a light blue cap and side-button. Onset of action has been observed as early as 8 hours after initial administration. S$1.00. The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000. The bottle is in an off-white plastic casing with a light blue cap and side-button. wash your hands before and after applying, do not wash the treated area after immediately applying. Under the sub-headings ‘Posology/Children under 6 years of age’, revised the wording to read: The safety and efficacy of Avamys in children under the age of 6 years has not been established. Side effects of Veramyst Nasal Spray include: sores in the nose that won't heal, headache, throat infection, Increases in IOP (, 7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo. Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. Taking more, Do not give your medicines to other people even if you know that they have the same. Each spray of the suspension delivers approximately 27.5 micrograms of micronised fluticasone furoate as an ex-device dose. So to have a nasal spray which will ease both nasal and ocular symptoms and can be delivered in such an effective manner is most welcome." In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo. It reduces inflammatory reactions in the airways. It is designed to assist doctors and pharmacists in prescribing and supplying the product. tabletwise.net website users have reported same day and 3 days as the most common time it takes before they saw improvements in their conditions. Using the active ingredient fluticasone furoate, it works to relieve inflammation in the nasal passages.. Increases in posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or glaucoma. Trademarks & Trade names used herein are the property of their respective holders. negligible influence on the ability to drive and use machines. 4.4     Special warnings and precautions for use. These times may not be reflective of what you may experience or how you should use this medicine. to read: Avamys is indicated in adults, adolescents and children (6 years and over), 4.2       Posology and method of administration. Invite your friends to TabletWise learning marketplace. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. AVAMYS nasal spray is a white suspension contained in an amber glass bottle, fitted with a pump. tabletwise.net website users have reported once a day and twice a day as the most common frequency of using Avamys Nasal Spray. Avamys contains benzalkonium chloride. Under the subheading ‘Seasonal and perennial allergic rhinitis in children’ replaced the following statement regarding growth rate: Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate in children (6 to 11 years). Please consult with your doctor to check how long do you need to use Avamys Nasal Spray. In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo. That way the medication will end up at the right place. Flixotide Nebules 0.5mg/2ml 10's . For the best results, this medication should be Consult with your doctor before using this medicine on open wounds, dry, chapped, irritated, or sun-burned skin. Avamys Nasal Spray . Designed to be used just once a day, it can prevent hay fever symptoms from taking hold if used … Seasonal and perennial allergic rhinitis in children, The following convention has been used for the classification of frequencies: Very common. It requires several days to take effect. Avamys undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone furoate in patients with severe liver disease is likely to be increased. Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance. Please follow your, tabletwise.net website users have most commonly reported usingAvamys Nasal Sprayafter food. Corticosteroids are hormones produced naturally by the adrenal glands that have many important functions, including control of allergic and inflammatory responses. Each spray of the suspension delivers However, this may not be reflective of how you should use this medicine. The most common side effects with this medicine are nosebleed. *Epistaxis was generally mild to moderate in intensity. In very rare cases, the binyrebark hormone in the nose can penetrate the nasal partition and make holes. To use: Summary of Product Characteristics last updated on medicines.ie: 28/8/2020. Avamys has no or negligible influence on the ability to drive and use machines. Warnings & Precaution and Clinical Studies – Details: Addition of findings from a two-year ocular safety study in adults/adolescents. Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms). When administered in the nasal passages, fluticasone is absorbed in the nasal cells, preventing the release of chemicals from triggering an allergic response to irritants such as pollen. The experience in children under the age of 6 years is limited (see section 5.1 and 5.2). What are the side-effects of Avamys Nasal Spray? Avamys nasal spray should be administered daily at a fixed time. In the UK Avamys nasal spray is … As with other intranasal corticosteroids, physicians should be alert to potential systemic steroid effects including ocular changes (see Pharmacodynamic properties). Update to section 4.4 and 4.8 to include warnings and adverse event related to blurred vision following PRAC recommendation. These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject. These effects vary between patients and different corticosteroids (see section 5.2). flutikasonifuroaatti. Under the sub-headings ‘Posology/Hepatic Impairment’ added the warning: Caution should be exercised when dosing patients with severe hepatic impairment as patients with hepatic impairment may be more at risk of systemic adverse reactions associated with corticosteroids. Add to Cart. The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Nasacort AQ 55mcg Nasal Spray 30 doses. AVAMYS Nasal Spray is a white, uniform suspension contained in an amber glass bottle, fitted with a metering (50 microlitres) atomising spray pump. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had ³0.3 increase from baseline in posterior subcapsular opacity. private prescription price learn more . For the best results, this medication should be What precautions should you take while using Avamys Nasal Spray? A randomised, double-blind, parallel-group, multicenter, one-year placebo-controlled clinical growth study evaluated the effect of fluticasone furoate nasal spray 110 micrograms daily on growth velocity in 474 prepubescent children (5 to 7.5 years of age for girls and 5 to 8.5 years of age for boys) with stadiometry. avoid getting this medication in your eyes or nose or mouth. Increases in IOP (³7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo. Avamys nasal spray is an effective treatment for nasal allergy symptoms — applied once or twice per day to each affected nostril, it will work quickly to reduce inflammation, clearing your airways and soothing your discomfort. Adults can also buy it from pharmacies and supermarkets. The intranasal device should be shaken before use. The following warning was added regarding a reduction in growth rate in children and the potential systemic steroid effects including ocular changes. Hepatic Impaired Patients: No dose adjustment is required in mild to moderate hepatic impairment. 0.3 increase from baseline in posterior subcapsular opacity. Safety and efficacy in this group has not been well established. 4.2     Posology and method of administration. It may cause irritation of the nasal mucosa. (n.d.). It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. So I was prescribed a nasal spray that I was supposed to test. Avamys Dosage Instructions and Avamys Nasal Spray Uses should be followed at all time it is also important that the maximum Avamys Dosage is not exceeded. Aim the nozzle of the sprayer, during the administration of the nasal spray, as much as possible to the outside of the nostril (so not toward the nasal septum) and inhale the liquid well. When should you not use Avamys Nasal Spray? Increases in posterior subscapsular opacity (³0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group. Avamys Nasal Spray Uses its anti-inflammatory ingredients to provide effective relief from unwanted symptoms in a little as eight hours after the first spray. Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control (see Posology and method of administration). If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks). For full therapeutic benefit regular, scheduled usage is recommended. Fluticasone nasal spray is available on prescription for adults and children. Checklist of steps. The opinions expressed in the surveys shown on the, By registering for a TabletWise account, you agree to our. For adults and adolescents 12 years of age and older, the recommended dose is 2 sprays in each nostril once daily, preferably at the same time each day. Examples include. No dose adjustment is required in this population (see section 5.2). Avamys is a nasal spray which is used to treat symptoms of allergic rhinitis (allergies) including a stuffy, blocked, runny or itchy nose, sneezing, and itchy, red or watery eyes. It's difficult to dose correctly and you feel as if hardly anything is coming out so then you take an extra dose, a spray is supposed to last about 6 weeks. Avamys nasal spray is indicated for the treatment of the symptoms of allergic rhinitis in adults, adolescents and children (aged 6 and over) 1 Allergic Rhinitis Myths and Facts Learn some facts about Allergic Rhinitis (Hay Fever) by downloading our myths and facts information leaflet. Avamys Nasal Spray is used for Inflammatory manifestations of corticosteroid-responsive dermatoses, Allergies, Allergic, Stuffy, Runny or itchy nose, Pruritic manifestations of corticosteroid-responsive dermatoses and other conditions.Avamys Nasal Spray may also be used for purposes not listed in this medication guide. It may be prescribed for adults and children aged six years and over. This may result in a higher frequency of systemic adverse events (see section 4.2 and 5.2). The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Yes, inflammatory manifestations of corticosteroid-responsive dermatoses and allergies are among the most common reported uses for Avamys Nasal Spray. applying an excessive amount may result in pilling. Please note that this medicine may be available in various strengths for each active ingredient listed above. Some nasal sprays, such as Dymista, contain fluticasone mixed with other medicines, … These reactions in the body may be due to allergens such as pollen ( hay fever ), dust … This medicine is not recommended for use as the primary treatment for asthma. There are no data in patients with severe hepatic impairment (see section 4.4 and 5.2). Steroid nasal sprays, also called corticosteroid nasal sprays, are anti-inflammatory medicines that you spray into your nose. They can be used to treat a range of conditions, including hay fever, sinusitis, non-allergic rhinitis and nasal polyps. Section updated and rearranged under two sub-headings ‘Posology’ and ‘Method of administration’. Approved heading text corrected and a redundant cross reference to SmPC 4.4 removed. Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Avamys nasal spray contains the active ingredient fluticasone furoate. This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing. The bottle contains either 30 or 120 sprays. The casing has a window for viewing the bottle contents. Typically, it is used for allergic rhinitis. Each spray delivers approximately 27.5 micrograms S$2.00. However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1). The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms). The intranasal device should be shaken before use. Respiratory, thoracic and mediastinal disorders. Avamys nasal spray contains the active ingredient fluticasone furoate, which is a type of medicine known as a corticosteroid (or steroid). Avamys nasal spray side effects. In case you miss a dose, use it as soon as you notice. Inflammatory manifestations of corticosteroid-responsive dermatoses, Pruritic manifestations of corticosteroid-responsive dermatoses. This is seen very rarely, but is important to be aware of. Epistaxis was generally mild to moderate in intensity. Warnings & Precaution and Clinical Studies – Details: Addition of findings from a two-year ocular safety study in adults/adolescents. AVAMYS NASAL SPRAY. Avamys is a corticosteroid. The casing has a window for viewing the bottle contents. Renal Impaired Patients: No dose adjustment is required in this population (see section 5.2). The duration of treatment should be restricted to the period that corresponds to allergenic exposure. Increases in posterior subscapsular opacity (, 0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group. n/a. $45.99 discounted pbs price learn more. As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently. 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