APIDRA Solostar 100iu/ml sanofi pen for diabetes treatment (5 pens x 3ml)

Dosage form Box of 5 pcs x 15ml
Specifications Insulin Glulisine
Ingredient Type 2 diabetes, type 1 diabetes

Ingredient

Thành phần cho 3ml

Composition information	Content
Insulin Glulisine	100iu/ml

Uses

Indications

Apidra Solostar is indicated for diabetes treatment for adults, teenagers and children aged 6 and older.

Pharmacy

Insulin Glulisine is an insulin similar substance for recombinant energy equivalent to ordinary human insulin. Insulin Glulisine has a faster onset and shorter impact time than conventional human insulin.

The main activity of insulin and insulin similarities, including glulisine insulin, is the regulation of glucose metabolism. Insulin lower blood glucose levels by stimulating peripheral glucose, especially in muscular and fat, and inhibits the production of glucose in the liver. Insulin inhibits lipid resolution in fat cells, inhibits protein resolution and enhances protein synthesis.

Exodulin insulin often has all the pharmacological effects of endogenous insulin. Insulin stimulates carbohydrate metabolism in muscle tissue - bone, heart and fat by creating favorable conditions for 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, inhibits fat and releases free fatty acids from fat cells. Insulin also stimulates protein synthesis.

Use insulin with appropriate doses for Type 1 diabetes (insulin -dependent) recovery temporary recovery ability to convert carbohydrates, fat and protein, to store glucose in the liver and to convert glycogen into fat.

When insulin with appropriate doses used evenly for people with diabetes, the appropriate concentration of glucose in the blood is maintained, the urine is relatively without glucose and cetone, preventing diabetes and coma.

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

pharmacokinetics

In a study in 18 men with type 1 diabetes, from 21 to 50 years old, Insulin Glulisine shows the properties of the dose ratio when exposed early, maximum and completely within the dose ranges from 0.075 to 0.4 units/kg.

absorption

Mobile pharmacokinetic properties on healthy volunteers and diabetes patients (Type 1 or 2) Prove that the absorption of Glulisine insulin is nearly twice as fast as the peak concentration is approximately close to normal human insulin.

When the insulin Glulisine is injected under the skin into the abdominal wall, shoulders and thighs, the concentration of time is similar, with the absorption when injected in the abdomen is slightly faster than the thigh injection, and the absorption when injected in the shoulder is in the middle range.

Absolute bioavailability (70%) of the similar glulisine insulin between injection sites and low variables in the same object (variable coefficient of 11%).

Distribution and elimination

The distribution and excretion of glulisine insulin and normal human insulin after the same intravenous injection, with the volume of distribution in the order of 13 liters and 22 liters and the sale time is 13 and 18 minutes.

After subcutaneous injection, Glulisine insulin is eliminated faster than conventional human insulin, with an apparent half -selling time of 82 minutes compared to 86 minutes. Glulisine insulin is less attached to plasma proteins, similar to human insulin.

Before taking APIDRA Solostar 100iu/ml sanofi pen for diabetes treatment (5 pens x 3ml)

How to use

APIDRA injection pen is injected under the skin or infusion under the skin continuously by pump.

Should inject Apidra Solostar under the skin of the abdominal wall, thigh or shoulder or constant infusion in the abdominal wall. It is necessary to alternate the injection or infusion position in an injection area (abdomen, thigh or shoulder) between injections.

The speed of absorption, onset and impact time can be affected by the injection position, physical movement, and other variables. Injecting subcutaneously in the abdominal wall ensures a slightly faster absorption than other injection sites.

Be careful to make sure not to stab the needle into the blood vessel. After injection, do not rub the injection site. Patients need to be trained to inject medicine properly.

Mixing insulin: Because there is no study of compatibility, not mixed with insulin glulisine with other drugs except for human insulin.

Before using solostar injection pen, you must carefully read the instructions for use in the instruction sheet in the drug box.

How to manipulate Apidra Solostar:

To prevent infection transmission, each pen is only used for one patient. Only use needles compatible with Apidra Solostar. Use only if the solution is clear, colorless and not seen in it. Do not shake or mix the drug before use. This type of unit is used for insulin glulisine and unlike the international unit (IU) or the unit used to represent the content of other insulin -similar drugs.

Insulin Glulisine should be injected for a short time (0 - 15 minutes before or after meals.

Use glulisine insulin in regimen with an insulin similar substance that works long or medium or background insulin and can be used with oral hypoglycemic drugs.

The dose of insulin glulisine must be adjusted for each person.

kidney failure

The pharmacokinetic properties of the glulisine insulin are often maintained on patients with renal failure. However, insulin demand may be reduced when the presence of renal failure.

Hepatic failure

The pharmacokinetic properties of the glulisine insulin have not been surveyed in patients with liver function impairment. In patients with liver failure, insulin demand may be reduced due to reduction in the ability to produce sugar and reduce insulin metabolism.

Elderly

Dynamic kinetics in elderly diabetes patients are limited. The impaired renal function can lead to insulin demand.

Children and teenagers

There is no clinical information about the use of glulisine insulin in children under 6 years old.

What to do when overdose?

can treat mild hypoglycemia by giving glucose or sugar -containing products. Therefore, patients with diabetes should always carry a little sugar, candy, biscuits or juice with sugar.

can treat severe hypoglycemia, when the patient becomes out of perception, with glucagon (0.5 - 1 mg) intramuscularly or subcutaneously injected by a person who has been instructed appropriately or by intravenous glucose. Glucose is also intravenous if the patient does not respond to Glucagon for 10 - 15 minutes. Once the perception is regained, the patient should use carbohydrates by oral to prevent recurrence.

After glucagon injection, patients should be monitored in the hospital to find the reasons for severe hypoglycemia and prevent other similar attacks.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Apidra Solostar, you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Metabolic: Hypoglycemia.

Common, 1/100 Skin and subcutaneous tissue: The response to the injection and the local allergic reaction (red, swollen, itching at the injection site).

Hypersensitivity: allergic reactions (urticaria, chest tightness, shortness of breath, atopic dermatitis and itching, anaphylactic reaction).

Skin and subcutaneous tissue: Fatty disorder.

Instructions on how to handle ADR

Local allergic reactions may occur with any type of insulin and may occur within 1-3 weeks after the beginning of treatment. Local reactions are relatively light and usually out of a few days or weeks. Poor injection techniques also contribute to local reactions. Sensitive manifestations usually occur within 30 - 120 minutes after injection, may last for a few hours or day and usually stop.

Insulin allergies are really rare, manifested by body urticaria, burning, shortness of breath, wheezing, hypotension, heart beating, sweating, angioedema and anaphylaxis. These reactions mainly occur when interrupted insulin or in humans with anti -insulin antibodies in the blood.

Many heavy cases require emergency treatment. Any patient who has a severe allergic reaction must be tested for skin before taking any new insulin. It is possible to sensitive for patients with allergic potential. Because often allergic to cow or pig insulin, or protamine, or protein, can prevent later allergies by replacing a low protein insulin (such as refined insulin including human insulin) or non -protamine.

If the Somogyi effect, reduces the afternoon dose of insulin effects or increases dinner. If the dawn phenomenon, increased the evening dose of insulin acting intermediate and/or late injection (such as injecting at bedtime, not injecting at dinner).

The most common ADR of insulin is hypoglycemic blood glucose and may also lower potassium. Pay special attention to high -risk people such as hunger, poor response against blood glucose (such as patients with plant neuropathy, pituitary or adrenal impairment, beta blockers) or users of potassium -reducing drugs.

Glucose concentration and blood potassium must be closely monitored when intravenous insulin. Quickly changing blood glucose levels can promote the hypoglycemia of blood glucose regardless of how much blood glucose concentration.

It is possible to reduce the potential risk of lowering blood glucose after eating due to insulin effectively by changing meals, eating, eating, changing exercise, regular monitoring of blood glucose, adjusting insulin and/or switching to insulin faster (such as insulin lispro, glulisine insulin).

Hypoglycemia of severe and frequent blood glucose occurs is an absolute indication that changes the treatment regimen. People with diabetes before driving, blood glucose must be checked and must take measures to avoid hypoglycemia of blood glucose (source of glucose) on the vehicle.

Hypotension treatment of blood glucose: For mild hypoglycemia, it is best to pass through the mouth of 10 - 20 g of glucose, or any carbohydrate food containing glucose such as orange juice or juice, sugar, alum sugar ... The dosage can be repeated 15 minutes later if the blood glucose is still less than 70 mg/dl (self -measurement) or still symptoms of hypoglycemic blood glucose. Once blood glucose returns to normal, eat a meal if it is near for meals or a snack.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

APIDRA Solostar drug is contraindicated in the following cases:

Hypersensitivity to the active ingredient insulin or other ingredients of the drug.

Caution when using

Transferring a patient to use a new type or a new insulin brand that needs to be performed under tight medical monitoring. Changes in content, brand (manufacturer), type (normally, NPH, slow ...), species (objects) and/or production methods can change the dose. Need to adjust the medication to treat diabetes.

Used inadequate or stop treatment, especially in insulin -dependent diabetes patients, can lead to hyperglycemia and acidosis - diabetes, potential conditions.

Transferring patients to a new type or a new insulin brand that needs to be carried out under tight medical monitoring and may need to change the dose.

Hypoglycemia

The time of hypoglycemia depends on the impact properties of insulin used, so it will change when the treatment regimen changes.

Conditions that make the early warning symptoms of hypoglycemia or less obvious including long -term diabetes, enhanced insulin therapy, diabetic neuropathy, medication like beta blockers or after moving from animal -based insulin to human insulin. It is also necessary to adjust the dose if the patient increases physical activity or changes the regular eating plan. Physical exercise right after a meal can increase the risk of hypoglycemia.

If hypoglycemia occurs after an insulin injection is similar to a quick effect, it can occur earlier when compared to the dissolved human insulin.

Hypoglyc or hyperglycemia reactions, if left untreated, can cause loss of perception, coma or death.

Insulin needs may change during illness or psychological disorders.

The ability to drive and operate machinery

The patient's concentration and reaction ability may decrease due to the result of hypoglycemic or hyperglycemia or may be due to vision impairment for example. This will be a risk in situations where these capabilities play an important role (for example: driving or operating machine).

Pregnancy

Classification of drugs for pregnant women according to Australian Drug Administration (TGA): B3.

Classification of drugs for pregnant women under the US Food and Drug Administration (FDA): c.

There is no enough data on the use of glulisine insulin on pregnant women.

Animal reproductive studies do not detect any difference between glulisine insulin and human insulin on pregnant women, embryo/fetal development, birth or postpartum development.

Be careful when prescribing pregnant women. Must monitor Glucose control carefully.

The important thing for patients with diabetes before or diabetes during pregnancy is to maintain good control of metabolism during pregnancy. Insulin demand may decrease in the first three months and usually increase in the middle and the last three months of pregnancy. Immediately after birth, insulin demand decreases rapidly.

Breastfeeding period

It is unclear whether the insulin Glulisine is secreted into breast milk or not, but in general, insulin does not go into breast milk and is not absorbed through the mouth.

breastfeeding women need insulin dose and diet adjustment.

Drug interaction

There are no studies on pharmacokinetic interaction. Based on experience through experience with similar pharmaceutical products, it is less likely to occur clinical pharmacokinetics.

There are some substances that affect glucose metabolism and may need to adjust the glulisine insulin dose and especially be closely monitored.

The enhancer of the bloodstream lowering effects in the blood include: oral diabetes, enzyme inhibitors Angiotensin (ACEI), Disopyramide, Fibrate, Fluoxetine, Monoamine Oxidase inhibitors (MA MAI), Pentoxifylline, Propoxyphene, Salicylate, Salicylate and antibiotics Sulfonide.

Substances that reduce the effect of lowering blood glucose include: corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropine, sympathetic drugs (for example: Epinephrine [Adrenaline], Salbutamol, TERBUTALINO Progestin (for example, contraceptive pill), protease inhibitors, non -typical anti -psychotic drugs (for example: olanzapine and clozapine).

Beta, clonidine, lithium or alcohol blockers can enhance or reduce the effect of lowering glucose in the blood of insulin. Pentamidine can cause hypoglycemia, then sometimes hyperglycemia.

Storage

Unused injection pen

Store in the refrigerator (2 - 8 ° C). Do not freeze. Do not place the glulisine insulin close to the freezer or ice.

Keep the recharge pen in its box to avoid light.

Before the first use, the pen must be in the room temperature for 1-2 hours.

The limit after opening the pen cap: the product can be preserved for up to 4 weeks at a temperature of not more than 25 ° C, avoiding heat or direct light. Do not stored injected pen in the refrigerator. After each injection, cover the pen lid to protect to avoid light.

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