Toujeo Solostar 300U/ml sanofi injection is treated with diabetes (5 trees)

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Specifications Insulin Glargine

Ingredient

Thành phần cho 1ml

Composition information	Content
Insulin Glargine	300UI

Uses

indications

Toujeo Solostar is designated to treat diabetes in adults.

Pharmacokology

Mechanism of impact

The main activity of insulin, including insulin glargine, is to regulate glucose metabolism. Insulin and its similar substances lower blood glucose levels by stimulating peripheral glucose, especially in muscular and fat, and by inhibiting the production of glucose in the liver.

Insulin inhibits fat cell resolution, inhibits protein resolution and enhances protein synthesis.

Pharmaceutical effect

Insulin Glargine is a human insulin similarity designed for low solubility in neutral pH. At pH 4, insulin glargine is completely dissolved. After injecting the subcutaneous tissue, the acidic solution is neutralized, resulting in the formation of a precipitate from which release continuously small amounts of insulin glargine.

As seen in glucose studies in type 1 diabetes patients, the low -glucose effect of Toujeo proved stable and lasted than the 100 -unit/ml of Insulin Glargine after subcutaneous injection. Figure 1 shows the results from a diagonal research study on 18 type 1 diabetes patients conducted for up to 36 hours after the injection. The effect of Toujeo exceeds 24 hours (up to 36 hours) in clinical doses.

Insulin Glargine release from the toujeo precipitate is longer than the 100 -unit/ml of insulin glargine, which can be attributed to a reduction of two -thirds of the injection volume, making the precipitate with a smaller surface area.

Pharmacology Toujeo Solostar

Insulin Glargine is converted into 2 metabolites with activity M1 and M2.

Insulin receptor: In vitro studies show the affinity of insulin glargine and its M1 and M2 metabolites to human insulin receptors similar to human afflictions.

IGF-1 receptor: The pressure of insulin glargine for IGF-1 receptors is about 5 to 8 times the pressure of human insulin (but lower than the affinity of IGH-1 is about 70 to 80 times), while M1 and M2 are attached to the IGF-1 receptor with a slightly lower pressure than human insulin.

Total therapeutic concentration of insulin (insulin glargine and its metabolites) on patients with type 1 diabetes 1 is significantly lower than the necessary concentration to occupy half the IGF-1 receptor and thereby activating the Mitogen hyperactor due to the IGF-1 receptor receptor. The physiological concentration of endogenous IGF-1 can activate the mitogen hyperlage line; However, the concentration of therapy in insulin therapy, including Toujeo therapy, significantly lower than the pharmacological concentration needed to activate IGF-1.

In a clinical pharmacological study, intravenous glargine insulin and human insulin show the same strength when used at the same dose.

As all other insulin, the impact time of insulin glargine may be affected by physical activity
and other variables.

Mechanism of action:

Exodulin insulin often has all the pharmacological effects of endogenous insulin. Insulin stimulates carbohydrate metabolism in muscle tissue - bone, heart and fat by facilitating the process of transporting glucose into the cell. Neurological tissue, red blood cells, and intestinal, liver and kidney cells without insulin to transport glucose. In the liver, insulin facilitates glucose to glucose-6-phosphate, which is converted into glycogen or continued metabolism.

insulin also works directly to fat metabolism and protein. This hormone stimulates fat and inhibits fat and releases free fatty acids from fat cells. Insulin also stimulates protein synthesis.

Give insulin with appropriate doses for people with type 1 diabetes (insulin dependents) temporarily recovering the ability to convert carbohydrates, fat and protein, to store glucose in the liver and to convert glycogen into fat. When insulin with the appropriate dose for each other for people with diabetes, the blood glucose is maintained, the urine is relatively without glucose and ceton, preventing diabetes and coma.

The effect of insulin is antagonistic by somatropin (growth hormone), epinephrin, glucagon, adrenal hormone, thyroid and estrogen. Insulin stimulates potassium and magnesi to move into the cell, thus temporarily reducing the increasing concentration of those ions.

pharmacokinetics

absorption and distribution

On healthy people and diabetes patients, after subcutaneous injection, Toujeo shows that insulin concentration in serum absorbs more slowly and lasts longer, creating a more flat time curve, compared to 100 units/ml.

Pharmacokinetic properties are suitable for the force of Toujeo. The concentration achieved a stable state within the therapy after 3-4 days of using Toujeo daily. After subcutaneous injection, Toujeo has a variable rate in the individual, defined as the variable coefficient of the insulin exposure level for 24 hours, at a low level (17.4%) in a stable state.

Biological Change

After subcutaneous injection, Insulin Glargine is quickly metabolized at the top of the carboxyl of the beta chain with the formation of two active metabolites M1 (21A-Gly-Insulin) and M2 (21A-Gly-Des-30B-Thr-Insulin).

In plasma, the main compound is the metabolite M1. The exposure to M1 increases in the dose of glargine insulin. The pharmacokinetic and pharmacokinetic results indicate that the effect of insulin glargine subcutaneously is mainly based on the exposure level with M1. On the vast majority of patients, insulin glargine and m2 metabolites are not detected, and when it is possible to detect, their concentration proved regardless of the dose and formula of the Insulin Glargine.

Elimination

When intravenous injection, the sale time of insulin glargine and human insulin is similar.

Toujeo's waste time after subcutaneous injection is determined by the absorption rate from the subcutaneous tissue. Toujeo waste sale time after subcutaneous injection is 18-19 hours and independent of the dose.

Before taking Toujeo Solostar 300U/ml sanofi injection is treated with diabetes (5 trees)

How to use

Before injection Toujeo:

Read the instructions carefully in the instruction sheet.

Injected into the front of the thigh, arm, or in front of the abdomen.

Every day should change the injection site in the selected injection area. Doing so will reduce the risk of skin atrophy or thickness.

To prevent the ability to spread the disease, never use an insulin injected pen for more than one person, even when changing the needle.

always have to attach a new needle before each injection. Never use needles again. The reuse of needles increases the risk of needle and thus causing insulin -doses or overdose.

The used needle must be removed in a sharp container or instructions of the pharmacist or local regulations.

Instructions for using Toujeo Solostar

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Dosage

Prepared Toujeo Solostar recharge pen can be injected from 1 to 80 units in each injection, adjusting each hiccup 1 unit. The window indicates the dose on the solostar injection pen shows that the number of Toujeo units is injected. No need to recalculate the dose.

Based on lifestyle, blood sugar test results and previous insulin use will show:

How many toujeo should be used every day. This drug may be used with a short impact insulin, or with other anti -diabetes drugs. It is necessary to know these factors to be able to respond properly to changes in blood sugar levels and to prevent blood sugar too high or too low.

Flexible injection hours:

Toujeo injection once a day best at the same hour per day.

If there is liver or kidney disease: may need lower doses.

What to do when overdose?

If you have injected too much Toujeo, blood sugar levels may decrease too low. Patients should check blood sugar and eat more to prevent hypoglycemia.

Symptoms of hypoglycemic warning.

The first signs are usually systemic symptoms. The example of symptoms shows that blood sugar is decreasing too much or too fast, including: sweating, wet skin, fear, heart beating fast or irregular, hypertension and brushing chest drum. These signs often occur before signs of hypoglycemia in the brain.

Signs of hypoglycemia in the brain include: headache, hunger, nausea, vomiting, fatigue, drowsiness, irritation, sleep disorders, fighting, difficulty focusing, slow reaction, depression, drowsiness, hard -to -speak (sometimes losing voice), visual disorders, tremor, weakness, stinging sensation in hands, numbness, numbness, numbness, numbness, numbness, numbness, numbness, numbness convulsions, loss of perception.

When signs of less obvious hypoglycemia:

The first warning signs of hypoglycemia may change, less obvious or even if:

is the elderly. significantly. Patients should learn how to identify alarming symptoms.

If necessary, regular blood sugar tests can help recognize mild hypoglycemia. If it is difficult to recognize the signs of Minh's alarm, patients should avoid situations (driving for example) that can be dangerous for themselves or others because of hypoglycemia.What to do when hypoglycemia?

Do not be injected insulin: Use 10-20 g of sugar immediately, for example glucose, sugar or soft drinks. Do not drink or eat chemical sugar foods (such as drinks for dieters). They do not help treat hypoglycemia.

then eat something (eg bread) has the effect of increasing blood sugar for a long time. Patients should ask the doctor or nurse if they do not know what to eat. With Toujeo, the time to recover from hypoglycemia will be longer because it is a long -term effect.

If hypoglycemia occurs, 10-20 g must be reused.

Patients should immediately notify the doctor if they cannot control the condition of hypoglycemia or it recurs.

What to do when forgetting the dose?

If you forget to use Toujeo, you can inject Toujeo within 3 hours before or after the regular injection when needed.

If you miss a dose of Toujeo or do not inject enough insulin dose, blood sugar levels may rise quite high (hyperglycemia).

Note:

Do not get double the dose to compensate for the forgotten dose.

If the blood sugar is too high (hyperglycemia), the patient may not inject enough insulin.

Reasons for hyperglycemia:

Not injected or injected with insulin dose. technique.

thirst, urinate, tired, dry skin, red face, anorexia, hypotension, fast heartbeat, urine with glucose and ceton. Stomach pain, rapid and deep breathing, drowsiness or even loss of perception are signs of severe condition (meton acidosis) due to insulin deficiency.What to do when giving hyperglycemia?

Measure blood sugar and ceton in urine as soon as possible when any of the above signs occur.

Contact your doctor immediately if you have severe hyperglycemia or metonic acidosis. This condition must always be needed by a doctor, usually in the hospital.

Side Effects

Like all other drugs, Toujeo can cause side effects, although not everyone meets.

If you notice signs of blood sugar levels that are too low (hypoglycemia), patients should act immediately to increase blood sugar levels.

Hypoglycemia can be very serious and often encountered when treating insulin (may occur in 1/10 of patients).

Heavy allergic reaction (rare, occurs at ≤1/1000 patients).

Signs may be rash and body itching, edema in the skin or mouth, shortness of breath, want to faint (drop blood pressure) with fast heart rate and sweat. Heavy allergic reactions can be life -threatening. Patients should immediately notify the doctor if notice the signs of severe allergic reactions.

Other side effects

common: occurs at ≤1/10 patients.

Changes on the skin of the injection site: If the insulin injection is too many times in the same place, the skin may be wrinkled (atrophy) or thicken (hypertrophy of fat). Insulin will not work well. Changing the injection site at each injection will help prevent these abnormal changes. This reaction can spread around the injection site. Most mild reactions with insulin often disappear within a few days to a few weeks.

Eye reaction: a major change in blood sugar control (better or worse) can cause vision disturbance. If there is an eye disease associated with diabetes called "hyperlipation retinal disease", very low hypoglycemia can cause temporary vision loss.

Change taste (taste disorders).

muscle pain.

Warnings

Contraindicated

Do not use Toujeo if allergic to insulin glargine or any ingredients of the drug.

Precautions when using

Toujeo is not an insulin selected to treat diabetic kerematosa. Instead, in these cases, it is recommended to have an intravenous insulin injection (Regular).

In case of insufficient blood glucose control, or patients tend to have hyperglycemia or hypoglycemia, it is necessary to reconsider the patient's obedience, the injection site, appropriate injection techniques and all other related factors before considering the dose adjustment.

switch between 100 units/ml and Toujeo insulin

Because the 100 units/ml and toujeo insulin are not equivalent to biological and cannot be replaced by each other, the conversion may need to change the dose and should only be done under tight medical supervision.

switch between other insulin and Toujeo

Should only be transformed between one type or another insulin brand and Toujeo under tight medical supervision. Changes in content, brand (manufacturer), insulin type (regular, NPH, slow, long effect, etc.), origin (animals, people, human similar substances human insulin) and/or production methods can lead to change of dosage.

Diseases

Demonstration requires closer metabolism monitoring. Many cases need to be indicated for urine tests to find ceton forms, and often need to adjust insulin dose. Insulin demand usually increases. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates regularly, even if they can only eat less or unable to eat, or are vomiting etc ... and never remove insulin completely.

Insulin antibodies

Using insulin can cause the formation of anti -insulin antibodies. In some rare cases, the presence of these anti -insulin antibodies may require insulin dose to adjust the trend of increased or hypoglycemia.

Combining Toujeo with Pioglitazone

Cases of heart failure have been reported when used in combination with pioglitazone with insulin, especially in patients with risk factors for heart failure. This should be noted if considering combining Pioglitazone and Toujeo. If this combination is used, patients should be monitored with signs and symptoms of heart failure, weight gain and edema. Pioglitazone should be stopped if any cardiovascular symptoms worsen.

Always check insulin labels before each injection to avoid confusion between Toujeo and other insulin.

To avoid confusion and overdose, it is necessary to guide the patient to never use the syringe to withdraw the Toujeo from the pen.

Before each injection should use a new sterilized needle. It is necessary to guide patients not to reuse needles. The reuse of needles will increase the risk of needles and may lead to insufficient doses or overdose. In case of needle, the patient must follow the instructions described in step 3 of the instructions for the use of the enclosed pen in the packaging.

Patients must check the number of selected units on the window of the pen of the injection pen. Patients with blindness or poor vision need the help of another person with good vision and trained on how to use insulin injection pen.

The effect of drugs on driving and operating machinery

The patient's ability to concentrate and react may be reduced due to hypoglycemia or hyperglycemia or, for example, due to vision impairment. This may cause risks in situations where these capabilities are of special importance (for example, driving or using machines).

Advise patients to be cautious to avoid hypoglycemia while driving. This is especially important for those who reduce or are not aware of the warning symptoms of hypoglycemia or have regular hypoglycemia. Again whether to drive or use machinery in these cases or not.

Pregnancy

There is no clinical experience in using Toujeo in pregnant women.

For insulin glargine, there is no clinical data on cases of exposure from controlled clinical studies. A large amount of data on pregnant women (more than 1,000 pregnancy outcomes of drugs containing 100 units/ml glargine) shows no specific side effects of insulin glargine during pregnancy and does not cause fetal toxicity/newborn or specific malformations of insulin glargine.

Animal data does not show reproductive toxicity.

Can consider using Toujeo during pregnancy, if necessary in terms of clinical.

Patients with a history of diabetes or gestational diabetes need to maintain good metabolic control during pregnancy to prevent adverse adverse outcomes related to hyperglycemia. The demand for insulin can decrease in the first trimester, and usually increase in the second and third trimester. Immediately after birth, insulin demand decreased rapidly (increasing the risk of hypoglycemia). Need to monitor blood sugar control carefully.

Breastfeeding period

It is unclear whether insulin glargine will excrete in breast milk. It is predicted that there is no metabolic effect of insulin glargine absorbed to infants/breastfed babies because insulin glargine, is a peptide, digested into amino acids in human gastrointestinal tract.

Lactating women may need to adjust insulin and diet.

Drug interaction

Blood sugar may decrease (hypoglycemia) if used:

Any other drug used to treat diabetes. (Mao) - Used to treat depression. This drug may decrease too low, then sometimes causing hyperglycemia.

Blood sugar can increase (hyperglycemia) if used:

corticosteroids like cortisone - used to treat inflammation. Severe blood sugar. Phenothiazin - used to treat mental disorders.

Blood sugar can increase or decrease if used:

Beginent or clonidine blockers - Used to treat high blood pressure.

Betel blockers as well as "other sympathetic paralysis" (for example, clonidine, guanethidine, reserpine - used to treat high blood pressure) can make it difficult to identify signs of blood sugar alarm that is decreasing (hypoglycemia). They can even cover or block the first signs of hypoglycemia.

pioglitazone used at the same time as insulin

Some patients with type 2 diabetes and long -term heart disease or a history of stroke when treated with pioglitazone and insulin become heart failure. If there are signs of heart failure such as unusual shortness of breath, fast weight gain or local edema, patients should tell the doctor as soon as possible.

Toujeo and alcohol: blood sugar levels may increase or decrease if drinking alcohol. Should check blood sugar more often than usual.

Storage

Before using the first time:

Store in the refrigerator (2 ° C - 8 ° C).

Do not be stored in the refrigerator. Morning.

Other drugs

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