Protafan NM

Active material: insulin isophane (human genetic engineering)
When ATH: A10AC01
CCF: Human Insulin intermediate-acting
When CSF: 15.01.01.02
Manufacturer: NOVO NORDISK A/S (Denmark)

Pharmaceutical form, composition and packaging

Suspension for s / c administration white, while standing stratified, forming a white precipitate and a colorless or nearly colorless supernatant; stirring should be re-suspended sediment.

* 1 IU matches 35 ug of anhydrous human insulin.

10 ml – colorless glass vials (1) – packs cardboard.

Pharmacological action

Protafan HM Penfill – suspension of biosynthetic human insulin isophane average duration. Valid – through 1.5 hours after subcutaneous administration. The maximum effect develops between 4 and h 12 no. Duration of action – 24 no. Profile of insulin action is approximate: dose-dependent, and reflects the individual characteristics.

Pharmacokinetics

Insulin absorption and, Consequently, beginning hypoglycemic effect depends on the injection site (life, hip, buttocks), Injection volume, insulin concentration and other factors. The blood half-life of insulin is a few minutes.

Thus, insulin action profile depends mainly upon its rate of absorption. This process is influenced by many factors, resulting in possible significant individual differences. In the transition from insulin concentration 40 U / ml 100 U / ml insulin absorption minor changes due to the smaller volume offset higher its concentration.

Testimony

• insulin-dependent diabetes mellitus (type I);
• insulin dependent diabetes mellitus (type II): stage of resistance to oral hypoglycemic, partial resistance to these drugs (during combination therapy), intercurrent illness, operations, pregnancy.

Dosage regimen

Dose set physician individually in each case. The drug is used only for subcutaneous injection. After injection, the needle for a few seconds should remain under the skin, that provides complete dosing. When insulin-dependent diabetes mellitus (type I) formulation is used as a basal insulin in combination with fast INSULIN.

In insulin-dependent diabetes mellitus (type II) drug can be used as a monotherapy, and in combination with fast-acting insulin.

When transferring a patient with highly purified porcine or human insulin Protafan HM Penfill dose remains the same.

When translated from beef or mixed insulin Protafan HM Penfill dose should be reduced by 10%, except, when the initial dose of less than 0.6 U / kg body weight. At a daily dose of, exceeding 0.6 U / kg, Insulin must be administered in the form 2 and more injections at different locations.

How to use the cartridge Penfill and administration Before using, make sure, Penfill cartridge that there is no damage. Penfill cartridge is not used, If there is any visible damage, or if the width of the visible portion of the width of the rubber piston white stripes. Before, how to insert the cartridge Penfill in the pen, it should shake up and down. The movement should be made in such a way, a glass bead to a cartridge is moved from one end to the other. This manipulation should be repeated at least 10 time – until, until the liquid does not become turbid and white smooth. If the Penfill cartridge is already inserted in the pen, before each subsequent injection should be repeated manipulation of mixing.

After injection, the needle must remain under the skin for at least 6 sec. Button pen must be kept pressed until complete withdrawal of the needle from the skin. After each injection, the needle should be immediately removed. Penfill cartridge is intended solely for personal use. When the cartridge is inserted into the pen NovoPen 3, NovoPen 3 Demi or Innova, through the window of the cartridge holder must be visible colored stripe.

Side effect

Side effects, related to the effect on carbohydrate metabolism: hypoglycemic states (paleness, increased sweating, heartbeat, sleep disorders, tremor). Allergic reactions: rarely – skin rash. Other: transient refractive error (usually in early insulin).

Contraindications

• gipoglikemiâ;
• insulinoma;
• immediate type allergic reaction to the introduction of the human insulin preparations in anamnesis.

Pregnancy and lactation

During pregnancy and lactation the need for insulin patients varies, which should be considered in order to maintain adequate control of metabolism. Insulin does not cross the placental barrier. In applying the drug Protafan HM Penfill during lactation any risk to the child does not exist.

Cautions

Patients, receiving a day more 100 Units of insulin, when changing the drug be hospitalized. Switching from one drug to another insulin should be done under the control of blood glucose levels.

Effects on ability to drive vehicles and management mechanisms

After the transfer of the patient to biosynthetic human insulin can temporarily impair the ability to drive a car and are busy with other potentially hazardous activities, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: initial symptoms of hypoglycemia – sudden increased sweating, heartbeat, tremor, hunger, excitation, paresthesia in the mouth, paleness, headache, sleep disorders. In severe cases of overdose – coma. Treatment: light hypoglycaemia the patient can resolve itself, taking sugar or sugar-rich foods.

In severe cases, the / m or s / c is introduced 1 mg of glucagon. If necessary, continue therapy on / in the concentrated solutions of dextrose (Glucose).

Drug Interactions

The hypoglycemic effect of insulin reinforce MAO inhibitors, non-selective beta-blockers, sulfonamides, anabolic steroid, tetracikliny, clofibrate, cyclophosphamide, fenfluramin, preparations, containing ethanol.

Hypoglycemic effect of insulin is reduced oral contraceptives, glucocorticoids, thyroid hormones, thiazide diuretics, Heparin, lithium preparations, tricyclic antidepressants. Under the influence of reserpine and possibly as a weakening of salicylates, and potentiation of insulin.

Pharmaceutical interaction

Ethanol, Various disinfectants can reduce the biological activity of insulin.

Conditions and terms

Penfill cartridges should be stored in a package, protected from sunlight at temperatures between 2 ° to 8 ° C; Do not freeze. Used cartridge should not be stored in the refrigerator.