Examples of using Afrezza in English and their translations into Hebrew
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Colloquial
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Ecclesiastic
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Computer
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Programming
Prescribing Information for Afrezza.
Afrezza is the only inhaled rapid-acting insulin available today.
You must test yourblood sugar levels while using insulin, such as Afrezza.
Afrezza is not recommended for people who smoke or have recently stopped smoking.
Commercial product sales commenced in August 2016, after Afrezza transitioned from Sanofi to MannKind.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
We did not recognize any product manufacturing costs in the fourth quarter of 2014 as wehad not yet commenced commercialization of Afrezza.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
The most common side effect of insulin, including Afrezza(insulin human) inhalation powder, is low blood sugar(hypoglycemia), which can be serious and life-threatening.
Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.
Taking certain diabetes pills called TZDs(thiazolidinediones) with Afrezza can cause heart failure even if you have never had heart failure or heart problems before.
Afrezza net revenue and gross revenue grew 29% and 60%, respectively, compared to the first quarter of 2017.
During the first quarter of 2017, we received $30.6 million from Sanofi, pursuant to the settlement of the insulin put option, $16.7 million from the sale of a surplus building,and $2.1 million from shipments of Afrezza.
As of June 30, 2017, Afrezza product shipped to the wholesale and retail channel, but not yet recognized as revenue, was $2.6 million.
Research and development expenses were $4.3 million for the second quarter of 2016, a decrease of 44% compared to the second quarter of 2015,primarily due to a reduction in force in 2015 following the completion of Afrezza registration trials.
Afrezza is covered by many national and regional insurance plans and MannKind offers a savings card that reduces the copay for most commercially insured patients to as little as $15.
Selling, general and administrative expenses for 2016 were $46.9 million compared to $41.0 million for 2015, an increase of 14.4%,primarily due to increased costs for the sales and marketing of Afrezza, offset by decreased general and administrative expenses.
Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.
In conjunction with the approved labeling revision, MannKind received a letter of Fulfillment of Post-Marketing Requirements for PMR 2166-2 and PMR 2166-3,satisfying two of the four post-marketing requirements for Afrezza as described in the 2014 FDA approval letter.
Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing.
Product manufacturing costs were $11.2 million for the six months ended June 30, 2016, an increase of 47% compared to the same period in 2015,as manufacturing of commercial product resumed in preparation for the relaunch of Afrezza in the third quarter of 2016.
During the fourth quarter of 2016, cash receipts were $10.2 million from the sale of insulin to Sanofi,$4.8 million from shipments of Afrezza, $2.2 million from sales of insulin to a third party and $1.1 million from the collaboration with Receptor.
Sales of Afrezza continued to be lower than expected during the fourth quarter of 2015, culminating in a decision by Sanofi on January 4, 2016 to return the Afrezza rights to MannKind after a notice period, all of which impacted the value and recoverability of long-lived assets in accordance with accounting guidance.
Manufacturing of commercial product resumed in the second quarter of 2016,in preparation for the relaunch of Afrezza in the third quarter of 2016, resulting in the recognition of product manufacturing costs of $3.7 million for the three months ended June 30, 2016.
Selling, general and administrative expenses for the nine months ended September 30, 2016 were $31.6 million, a decrease of 3% from the same period in 2015, primarily due to the 2015 reduction in force, lower communication, facility and insurance costs and lower stock-based compensation expense in general and administrative expenses offset by increased costs for the support of sales andmarketing of Afrezza in selling expenses.
For the second quarter of 2017, total net revenue of $2.2million was comprised of $1.5 million of Afrezza product net sales, $0.1 million of collaboration revenues and $0.6 million of other revenues from the sale of certain oncology intellectual property.
Biomm's expertise in the diabetes market allowed the dossier to be updated quickly with the revised prescribing information, thereby providing physicians and patients,if and when Afrezza is approved in Brazil, with accurate information to achieve better glycemic control at mealtime.”.
There is still much to do in the comingmonths, but we are all highly motivated by the positive feedback we have received from enthusiastic Afrezza patients and we want to do all we can to ensure that more adults with diabetes have an opportunity to receive the same benefits.".
For the three and nine months ended September 30, 2016, we recognized $22.7 million of product costs-collaboration which was previously deferred and consisted of $13.5 million in Afrezza manufacturing costs for product sold to Sanofi and $9.2 million for a change in estimate in our recognized loss on purchase commitments related to the sale of raw insulin to Sanofi.
Similar results were presented in Poster 975-P and in a separate meta-analysis of three open-label clamp trials(Poster 931-P) comparing the onset of action of Afrezza with that of subcutaneous Lispro or regular human insulin, which showed onset of action(time to 10% GIR-AUC 0-240) with Afrezza was faster at 25 to 34 minutes compared to 53 to 60 minutes with Lispro.
