Novorapid Flexpen 100U/ml Novo Nordisk control pen controls blood sugar (5 trees x 3ml)

Dosage form Box of 5 trees x 3ml
Specifications Insulin aspart

Ingredient

Composition information	Content
Insulin aspart	100U/ml

Uses

indications

Novorapid 100iu/ml is indicated for treating diabetes in adults, adolescents and children aged 2 and older.

Pharmacokology

Mechanism of action

Novorapid® has a faster starting effect than soluble human insulin, along with a lower glucose concentration, according to the first 4 -hour assessment after eating. Novorapid® has a shorter time than human insulin dissolved after subcutaneous injection.

Novorapid ® will have an onset effect within 10-20 minutes after subcutaneous injection. The maximum efficiency is about 1-3 hours after the injection. Effects from 3 - 5 hours.

Insulin aspart is equivalent to the dissolved insulin on the base of grams.

Dynamic pharmacokinetics

In Novorapid®, Amino Acid Proline is replaced with Aspartic acid at the B28 position to reduce the trend of hexamer formation, such as dissolved human insulin. Therefore, Novorapid® absorbs faster in the subcutaneous tissue than the dissolved human insulin.

Time reaches an average maximum concentration of half of the human insulin . Maximum plasma concentrations up to 429 pmol/l, reaching 40 minutes after the skin injection under 0.15 U/kg body weight in patients with type 1 diabetes.

Slower absorption rate in patients with type 2 diabetes , leading to lower CMAX (352 ± 240 PMOL/L) and TMAX slower (60 minutes). The variation in the individual in terms of time to achieve the maximum concentration of Novorapid® significantly less than the dissolved human insulin, while the variation in the CMAX CMAX CMAX is larger.

Before taking Novorapid Flexpen 100U/ml Novo Nordisk control pen controls blood sugar (5 trees x 3ml)

How to use

Novorapid ® Use subcutaneous injection or continuous subcutaneous transmission by pump system.

Novorapid® can be injected directly into the veins performed by medical staff. Never be injected directly into the muscle (intramuscularly).

always changes the injection site in the same injection area to reduce the risk of swelling or skin dents. The best position of the self -injection base is: the front of the waist area (abdomen); Above the arm or front of the thigh. Insulin will work faster if injected around the waist area.

You should check blood glucose regularly.

How to use Novorapid®

Read the user manual, Novorapid® Flexpen® included. You must use Insulin injection pen as described in the user manual.

How to use Novorapid Flexpen 100UI/ml

How to use Novorapid Flexpen 100UI/ml 2

How to use Novorapid Flexpen 100UI/ml 3

Dosage

Novorapid® is an analogue insulin that works quickly. The dose of Novorapid® depends on the individual and the patient's needs. Often used in combination with intermediate or prolonged insulin effects, used at least once a day. Blood glucose monitoring and insulin dose adjustment to achieve optimal blood sugar control.

Insulin needs in adults and children in individual individuals are usually from 0.5 to 1.0 u/kg/day. In the treatment regimen - fast, 50-70% of this demand is provided by Novorapid® and the rest by insulin acting intermediate or prolonged effects. The dose should be adjusted if the patient intends to increase physical activity to change their normal diet or are having other illnesses.

Novorapid® has a faster onset and shorter effect time than dissolved human insulin.

Due to faster onset, Novorapid® is often used right before meals. When necessary, may use Novorapid Flexpen immediately after meals.

Due to the shorter acting time, Novorapid® is less likely to cause night hypoglycemia.

Special patient group

Like other insulin products, in elderly patients and patients with renal impairment or liver failure, should increase monitoring of glucose and dose insulin aspart should be adjusted to each patient.

used in pediatrics

Novorapid® can be used for children who prefer to use insulin in the form of soluble form due to the advantage of the fast -working starting time of the product. For example, choosing the time of injections related to meals,

Switch from other insulin products

When switching to other insulin products, the dose of Novorapid® is needed and the dose of the background insulin.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? However, hypoglycemia can develop in the following continuous stages if the dosage is too high compared to the patient's needs:

The mild hypotension can be treated by oral glucose or sugar products. Therefore, patients with diabetes are advised to bring people with sugar products.

The hypoglycemia, when the patient is unconscious, can be treated with intramuscular injection or subcutaneous injection of Glucagon (0.5 to 1 mg) due to a person who has been instructed on how to inject, or by medical staff glucose with intravenous tract. Glucose intravenous infusion if the patient does not respond to glucagon within 10-15 minutes. When the patient wakes up, the food contains carbohydrates to avoid coma again.

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 Novorapid 100iu/ml , you may experience unwanted effects (ADR).

Summary of safety

Observatory side effects found in patients using Novorapid® mainly depend on the pharmacological effects of insulin. The most commonly reported side effect during treatment is hypoglycemia. The frequency of hypoglycemia changes in a group of patients, the dosage regime and the level of blood sugar control .

When starting with insulin treatment, there may be abnormalities in refractive, edema and reaction at the injection site (pain, redness, urticaria, inflammation, bruising, swelling and itching at the injection site). These reactions are often temporary. The rapid improvement of blood glucose control may be associated with acute neuropathy, which can be recovered. Enhanced insulin therapy with sudden improvement in blood sugar control may be associated with diabetic retinopathy temporarily worse, while improving long -term blood sugar control reduces the risk of progression of diabetic retinopathy.

The side effects are listed below based on clinical test data and are classified according to the frequency and group of Meddra's organs. The frequency groups are determined according to the following convention: Very common (≥1/10); Common (≥1/100 to

The immune system disorders rarely - floating urticaria , ban, rash

very rare - Anaphylactic reaction* Blood* Nervous dysplasia rare - peripheral neuropathy (neurological pain)

Skin disorders and subcutaneous skin tissue less common - Fatty disorder*

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Novorapid 100iu/ml contraindicated for allergens (hypersensitivity) with insulin aspart or any excipient of Novorapid*.

Be cautious when using

read carefully instructions before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

Before moving to places with time zone difference, patients should be greedy for the doctor's opinion, because this means that the patient has to inject insulin and have meals at other times.

The following cases need to be cautious and notify the doctor or medical staff when encountered:

hyperglycemia .

Hypoglycemia.

switch to using other types of insulin.

The response at the injection site.

Combining thiazolidinedione and insulin drugs.

antibody resistant insulin.

Use in combination with other drugs.

Before using Novorapid®

Check the label to ensure the correct type of insulin.

Always use new needles for each injection to prevent contamination.

Do not allow others to use together Kim and Novorapid® Flexpen*

Not used in the following cases:

If you have an allergic (hypersensitivity) with insulin aspart or any excipients CO Novorapid®.

If you suspect you start hypoglycemia (low blood sugar)

If the Novorapid Flexpen injection pen falls, damaged or broken.

If the pen is not preserved or frozen.

If the insulin solution is not transparent and colorless.

Details cautious please look closely at the drug manual.

The ability to drive and operate machinery

The patient's concentration and reaction ability can be impaired as a result of hypoglycemia. This can be dangerous in situations where these possibilities are of special importance (such as driving or operating machinery).

Patients should be reminded to be careful to avoid hypoglycemia while driving. This is very important in patients who are aware of whether or not to recognize the warning signs of hypoglycemia or in people who often have hypoglycemia.

Pregnancy

Novorapid® (Insulin Aspart) can be used for pregnant women. Data from two random clinical trials with control shows that there is no side effects of insulin aspart in pregnant women and babies/babies when compared to soluble human insulin.

Need to strengthen blood glucose control and monitor pregnancy pregnant women with diabetes during pregnancy and when intended to get pregnant. The demand for insulin usually decreases in the first three months of pregnancy and increases gradually in the middle and the last three months of pregnancy. After birth, the normal insulin demand quickly returns the values before pregnancy.

breastfeeding period

There is no limitation of Novorapid® treatment during breastfeeding. The treatment of insulin in breastfeeding women does not risk children. However, the dose of Novorapid® may be needed.

Interactive drug

Some drugs are known to interact with glucose metabolism.

The following substances can reduce the insulin needs of the person: oral diabetes treatment drugs, Monoamine oxidase inhibitors (Maois), beta blockers, enamel inhibitors of angiotensin (ACE), Salicylates, Homosexuals and Sulphonamides.

Spring substances can increase the patient's insulin demand: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathetic strengths, growth hormones and danazol .

Beta blockers can cover hypoglycemic symptoms. Octreotide/Lanreotide may increase or decrease insulin demand. Alcohol can increase or reduce the hypoglycemic effect of insulin.

Storage

Storage in the linen (2 ° C - 8 ° C). To far from the cooling unit.

Novorapid Flexpen injection pen must be protected from excessive heat and light.

After the first use or carrying out: not in the refrigerator. Storage below 30 ° C.

Use within 4 weeks.

Do not freeze.

cover Novorapid® to avoid light.

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