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Post by rockstarrick on Aug 27, 2015 13:08:49 GMT -5
Glad I copied this before yahzoo deleted it, I'll share the un translated link also.
Selling in Brazil, sorry for the clutter, just want to keep you updated until we are in the green again. This is big news, more to come !!
Here is a google translation in English:
Taking Questions: Inhalable Insulin
The inhalable insulin was released by the National Health Surveillance Agency (Anvisa) for it to be marketed in Brazil. Although the effectiveness of inhaled insulin is proved, contrary to what many believe will not deliver medically people with diabetes traditional injections. Dr. Vivian Ellinger, Chairman, Department of Diabetes SBEM, explains why in the interview below.
For now, only a laboratory of the pharmaceutical industry will begin to provide the medically by air, but other investigations are under way. The Brazil even has centers that are supporting international studies. Which are being researched this and other types of insulin inhaled.
The inhaled insulin will deliver people with diabetes injections?
. Dr. Vivian Ellinger - This was the first impression that the launch of Exubera caused, but it is not true. This new insulin is fast-acting, ie it serves to correct or prevent hyperglycemia peaks. However, the patient needs to basal insulin, and what is more important, need to realize the bite to measure blood glucose several times a day.
Undoubtedly is an industry breakthrough that in recent years has invested a lot in ways to improve the management of diabetic patients.
Anvisa released the entry of the drug in the country?
Dr. Vivian Ellinger -. ANVISA (National Health Surveillance Agency) approved at the beginning of June, not long after other countries. It is expected that this year is already on sale in Brazil.
There are other studies that may lead to alternative medications (non-injectable) to control your blood sugar?
Dr. Vivian Ellinger. - There is a new group of treatment for patients with type 2 diabetes who are very promising. These drugs improve the function of pancreatic beta cells through gastrointestinais.Além hormone action on the release of insulin, there is a suppression of glucagon, which is a hyperglycemic hormone.
The first drug of this group Less
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Post by rockstarrick on Aug 27, 2015 13:10:23 GMT -5
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Post by rockstarrick on Aug 27, 2015 13:14:37 GMT -5
Here is a small copy paste from our FDA clinical trials.
udricky • 1 hour 44 minutes ago Remove 3users liked this postsusers disliked this posts0Reply
Clinical trials were conducted in Brazil before FDA approval. Can't confirm approval, but this is from the Clinical Trials.
Study 171 was an open label, randomised trial that enrolled 518 type 1 diabetes patients on basal insulin therapy. It was conducted at multiple centres across the US, Russia, Brazil, and Ukraine.
A link would be nice. Less
Inch by inch.
The article and link were posted after this, so please excuse the "can't confirm approval" comment.
Good Luck Longs
Rock
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Post by rockstarrick on Aug 27, 2015 13:54:06 GMT -5
This is not Exhubra, very obvious to me. . Dr. Vivian Ellinger - This was the first impression that the launch of Exubera caused, but it is not true. This new insulin is fast-acting, ie it serves to correct or prevent hyperglycemia peaks. However, the patient needs to basal insulin, and what is more important, need to realize the bite to measure blood glucose several times a day. Read more: mnkd.proboards.com/thread/3378/afrezza-selling-brazil#ixzz3k2jKZBgQ |
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Post by bradleysbest on Aug 27, 2015 13:58:23 GMT -5
Be interesting to know how long it's been selling , sales numbers etc... Go Brazil!
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Post by Actual Investor on Aug 27, 2015 14:09:20 GMT -5
I hate to burst everyone's bubble but this is talking about the bong. Here are the last paragraphs.
Dr. Vivian Ellinger. - No, other laboratories are researching inhalable insulin, some already well advanced.
The gel for intranasal administration of insulin is another form of administration of study.
The insulin Exubera will be available only in blister packs containing 1 mg and 3 mg. When the administration of different doses is required, it will be difficult for the user to make this calculation?
The calculation should consider the blister of 1 mg corresponds to three international units of insulin and 3 mg correspond to 8 international units.
But what is expected of both the physician and the patient is that both start to think about the dosage in milligrams and forget the "international units". This is a new way to dispense and adjust the insulin dose. |
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Post by rockstarrick on Aug 27, 2015 14:15:20 GMT -5
I hate to burst everyone's bubble but this is talking about the bong. Here are the last paragraphs.
Dr. Vivian Ellinger. - No, other laboratories are researching inhalable insulin, some already well advanced.
The gel for intranasal administration of insulin is another form of administration of study.
The insulin Exubera will be available only in blister packs containing 1 mg and 3 mg. When the administration of different doses is required, it will be difficult for the user to make this calculation?
The calculation should consider the blister of 1 mg corresponds to three international units of insulin and 3 mg correspond to 8 international units.
But what is expected of both the physician and the patient is that both start to think about the dosage in milligrams and forget the "international units". This is a new way to dispense and adjust the insulin dose. I hate to burst your bubble, read this paragraph carefully please. This is not Exhubra, very obvious to me. . Dr. Vivian Ellinger - This was the first impression that the launch of Exubera caused, but it is not true. This new insulin is fast-acting, ie it serves to correct or prevent hyperglycemia peaks. However, the patient needs to basal insulin, and what is more important, need to realize the bite to measure blood glucose several times a day. Read more: mnkd.proboards.com/thread/3378/afrezza-selling-brazil#ixzz3k2oeSaSH |
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Post by kc on Aug 27, 2015 14:18:27 GMT -5
I hate to burst everyone's bubble but this is talking about the bong. Here are the last paragraphs.
Dr. Vivian Ellinger. - No, other laboratories are researching inhalable insulin, some already well advanced.
The gel for intranasal administration of insulin is another form of administration of study.
The insulin Exubera will be available only in blister packs containing 1 mg and 3 mg. When the administration of different doses is required, it will be difficult for the user to make this calculation?
The calculation should consider the blister of 1 mg corresponds to three international units of insulin and 3 mg correspond to 8 international units.
But what is expected of both the physician and the patient is that both start to think about the dosage in milligrams and forget the "international units". This is a new way to dispense and adjust the insulin dose. Write to her on LinkedIn. br.linkedin.com/pub/vivian-ellinger/25/66/964Vivian Ellinger Prof. Titular at Universidade Severino Sombra LocalidadeRio de Janeiro e Região, BrasilSetorPrática médica Cadastre-se no LinkedIn e acesse o perfil completo de Vivian Cadastre-se no LinkedIn e acesse o perfil completo de Vivian |
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Post by newmnkdinvestor on Aug 27, 2015 14:28:57 GMT -5
Why wouldn't she mention Afrezza?
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Post by Actual Investor on Aug 27, 2015 14:35:07 GMT -5
The insulin Exubera will be available only in blister packs containing 1 mg and 3 mg. When the administration of different doses is required, it will be difficult for the user to make this calculation?
The calculation should consider the blister of 1 mg corresponds to three international units of insulin and 3 mg correspond to 8 international units.
But what is expected of both the physician and the patient is that both start to think about the dosage in milligrams and forget the "international units". This is a new way to dispense and adjust the insulin dose.
Please explain why she is talking about milligram dosage and directly referencing Exubera with absolutely no mention of Afrezza? I would like to have Afrezza available in Brazil or any other foreign country. This isn't it. |
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Post by compound26 on Aug 27, 2015 14:35:37 GMT -5
This appears to be about Exubera. If you use google translation to translate the whole article, the last sentence is saying sometime like "as of this time, the inhaled insulin has stopped all marketing activities in Brazil" or something like that.
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Post by rockstarrick on Aug 27, 2015 14:38:30 GMT -5
This thread is getting confusing. I shared the complete translated article, it didn't include the last paragraph shared by the member claiming this was Exhubra, I'm going to dig a little deeper.
I guess the reason they didn't mention Afrezza is because nobody mentions it.
ill share what I find.
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Post by charlespk on Aug 27, 2015 14:52:03 GMT -5
Thanks for the post , I will look at the link when I am done with work today , I speak Spanish and Italian as well . Portuguese is similar enough to Spanish that I can understand about 90 % of it .
So I will give a shot tonight and give you my opinion.
Maybe before then , we have someone else on the board , that speaks Portuguese as his/her first language that can translate it for us
Thanks for the post .
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Post by bluemoth on Aug 27, 2015 15:02:40 GMT -5
sorry but I think it is clearly talking about Exubera. At the bottom of the interview there is one sentence "A insulina em questão teve sua comercialização interrompida, no Brasil, conforme comunicado publicado aqui" which links to the decision by Pfizer to suspend Exubera.
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Post by nylefty on Aug 27, 2015 15:06:41 GMT -5
Thanks for the post , I will look at the link when I am done with work today , I speak Spanish and Italian as well . Portuguese is similar enough to Spanish that I can understand about 90 % of it . So I will give a shot tonight and give you my opinion. Maybe before then , we have someone else on the board , that speaks Portuguese as his/her first language that can translate it for us Thanks for the post . Seems to me that it's more important to know when the article was written. Recently there was much excitement about an article from Mexico that seemed to say that Afrezza had been approved in that country. It turned out that the article was actually about the FDA approval in the U.S. in 2014. In any case, there are no references to Afrezza in the Brazilian article, but there are references to Exubera. |
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