Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA

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Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA Guidelines are provided as a source of correct to Civil Aviation Medicine Examiners (CAME). Whilst every effort is made to maintain Ado-trzstuzumab currency of these Guidelines, changes in medical science or clinical practice after time of publication may impact on the accuracy of these Guidelines and CAM gives no assurance as to the accuracy of them.

The Guidelines are not a statement about how CAM will proceed to make a decision in every case. Instead, they highlight to CAME's the likely areas of importance for certain safety-relevant conditions, and to inform the timely collection of appropriate information. CAM makes aeromedical decisions on a case by case basis. A particular assessment decision is based on the individual circumstances of the applicant under consideration.

Physicians are reminded that this document should be used as a guide only and it should not be confused with the medical standards for aviation personnel published in the Canadian Aviation Regulations (Standard 424 - Medical Requirements). Any specific questions should be directed to the nearest regional aviation medical office of the Civil Aviation Medicine Branch, Transport Canada.

If reading a printed copy, please ensure that the copy is the current version by checking the website. Note: All ITDM (Insulin Treated Diabetes Mellitus) applicants who have achieved medical certification will Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA monitored by a single physician (Kadxyla)- the CAM organization in order to maintain consistency and an adequate data base.

The major consideration in the medical certification of diabetics is the risk of subtle or sudden incapacitation. For the diabetic, this risk comes in the short term from the extremes in blood sugar levels and in the longer (Kafcyla)- from vascular damage. Let us therefore consider the metabolic conditions associated with diabetes.

Hypoglycemia refers to blood sugars outside Emransine normal range, and although both hyper and hypoglycemia are a concern in aviation, hypoglycemia would most likely precipitate an incapacitation. Hypoglycemia is usually considered to be a blood glucose concentration in the range below the level at which symptoms could be expected to occur.

In the person without diabetes, blood glucose is kept within a fairly narrow range by a homeostatic mechanism regulated by glucose intake and storage, insulin, glucagon, catecholamine, cortisol and growth hormone. In the diabetic, treated or not with medication, the fine control of this delicate homeostasis has been compromised. Hypoglycemia may result from too much insulin or insulin producing medication, too little glucose, an over-expenditure of energy or any combination of the above.

Of particular concern are the neuroglycopenic effects of hypoglycemia and the effect they have on information processing, obviously an extremely important aspect Injecion both piloting and air traffic controlling tasks. Results from multicentre trials reveal that the incidence of hypoglycemic reactions is more common among an intensively insulin treated group of patients with diabetes.

The severity of the hypoglycemic reactions can vary with the more severe reactions being related to the degree of Usee control and the effectiveness of the physiological counter regulatory mechanisms. The blood glucose Meropenem (Merrem I.V.)- Multum at which an individual may recognize hypoglycemia can vary as well and (Kadcyla)-- believed to be lower in those whose diabetes has been of a longer duration.

Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA is apparent then that the unpredictability of hypo or hyperglycemia could be a major aviation safety hazard in the cockpit or the air traffic control workplace.

Table 1 attempts Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA address the question of risk for hypoglycemia. Most Type 1 diabetics are Ado-trastuzumzb negative. The periodic medical assessment of all IVV has Ultrase (Pancrelipase)- Multum main Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA. The second is to assess the risk of incapacitation during the period of validity of the medical certificate for which he has applied.

This degree of risk should not be much in excess of the risk of the same condition occurring in a completely healthy person. Applicants who require medications to control blood sugars should be on a stable dosage.

For agents with a low hypoglycemic risk, the dose should be established and stable over a minimum of 3 months. For those who require agents at a higher risk of hypoglycemia, the established dose should be stable for a minimum of 6 months. Insulin pumps for drug Ado--trastuzumab may be authorized with a precaution for the risk of over delivery in the event of a rapid decompression. A template flow sheet for diabetes monitoring will be provided.

It is recommended that the applicant maintain its currency and accuracy for ease of review at the time of the periodic aviation medical and the final assessment by Civil Aviation Medicine. Note: Blood Glucose levels will be required to be maintained at higher than optimal values prior to and during flight, in order to minimize the risk of hypoglycemia.

This may have an effect on the long term health of the individual. The applicant must be made fully aware of this. Air Traffic Controllers must follow a similar protocol for glucose management with blood glucose testing occurring every 2 hours during working hours. The conference group has proposed the following risk stratification and matrix approach in developing guidelines for the medical certification of pilots, air traffic controllers and flight engineers with diabetes.

It must be understood that this matrix is intended as a general guide, as all factors will not necessarily carry equal weight and that each case will be reviewed individually. The highest level scored on any single row above will guide the applicant's overall diabetes risk assessment.

Individual factors, in conjunction with the framework table below, will affect the determination of the flying category allowed and any applicable restrictions. Complex or higher risk applicants may be reviewed by the Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA Medical Review Board. In accordance with current TC policy, applicants with Insulin Treated Diabetes Mellitus may be assessed for medical certificates as follows.

Those who already hold a professional pilot licence (ATPL, CPL) may be considered for a Category 1 medical certificate, restricted to flying with an accompanying pilot, as well as for a Category 3 or 4 medical certificateAn unstable metabolic disorder in the case of diabetes mellitus shall include any of the following.

All ITDM shall identify themselves as such to the shift supervisor. Individual ATCs with ITDM shall have appropriate medical supplies available at all times in the workplace. Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA the blood glucose (BG) falls below 3.

If at I within 30 min. Recheck BG in 30 minutes. Individuals with ITDM shall maintain the appropriate supplies for blood glucose management, which shall include: (a) A reliable calibrated glucose meter with memory chip and appropriate blood sampling equipment. Prior to flight blood glucose must be greater than 6. Blood glucoses must be monitored every 30 minutes during flight. If the blood glucose falls below 6. If, for operational reasons, the in-flight 30 minute blood glucose measurement Emtansne be done, then 10 gms.

The blood glucose should be measured 30 minutes prior to landing and if below 6. Asthma is a disorder characterized by increased responsiveness of the small airways to various allergens and non-specific stimuli resulting in widespread airways inflammation and reflex narrowing of the airways. It has a wide clinical spectrum varying from a single short-lived episode, requiring little or no medication to that ann oncol a constant, disabling condition requiring a Ado-trastuzumab Emtansine Injection for IV Use (Kadcyla)- FDA of therapeutic agents.

It's course and severity can be quite predictable in most, albeit less predictable in some.



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