ACTRAPID PENFILL 100 IU / mL

Generic drug of the therapeutic class: Metabolism and nutrition
Active ingredients: Insulin human
laboratory: Novo Nordisk A / S

Indication

Diabetes treatment.

Dosage ACTRAPID PENFILL 100 IU / mL Solution for injection Box of 5 Cartridges of 3 ml

Actrapid is a fast-acting insulin that can be used in combination with long-acting insulins.

Dosage

The dosage depends on each individual and is determined according to the needs of the patient. Individual insulin requirements are usually between 0.3 and 1.0 IU / kg / day. Daily insulin requirements may be higher in patients with insulin resistance (eg, puberty or obesity) and lower in patients with residual endogenous insulin secretion.

In diabetic patients, optimized glycemic control delays the onset of late diabetic complications. This is why it is recommended to carefully monitor blood glucose.

An injection must be followed, within 30 minutes, of a meal or snack containing carbohydrates.

Dosage adjustment

Concomitant diseases, particularly infections and febrile conditions, generally increase the patient's insulin requirements.

Renal or hepatic disorders may reduce insulin requirements.

Dosage adjustment may also be necessary if the patient changes his or her physical activity or diet.

Dosage adjustment may be necessary when the patient is transferred from one insulin preparation to another (see Warnings and Precautions section ).

Administration

Subcutaneously.

Intravenous administration of Actrapid from a pen or cartridge should be an exception only in situations where vials are not available. In this case, Actrapid should be aspirated into an insulin syringe avoiding the injection of air or infused via an infusion system. This procedure must be conducted by health professionals.

Actrapid is administered subcutaneously to the abdominal wall. Injections can also be performed in the thigh, in the gluteal region or in the deltoid region.

Subcutaneous injection into the abdominal wall ensures faster absorption than in other injection sites.

Injection into a skin fold reduces the risk of accidental intramuscular injection.

After injection, the needle should remain under the skin for at least 6 seconds to ensure

the injection of the entire dose.

Rotation of injection sites within an anatomical region should be performed to avoid lipodystrophy.

The cartridges are designed to be used with Novo Nordisk administration systems (durable devices for repeated use) and NovoFine or Novotwist needles. Follow the detailed instructions that accompany the administration system.

Actrapid is accompanied by a leaflet, the instructions must be followed.

Against indications

Hypersensitivity to the active substance or to any of the excipients (see section Composition ).

Hypoglycemia.

Adverse effects Actrapid Penfill

As with other insulins, the most common side effect is usually hypoglycaemia. This occurs when the insulin dose is too high compared to insulin requirements. In clinical trials and since marketing, the frequency of hypoglycaemia has varied according to the patient population and the doses used, so it is not possible to evaluate it. Severe hypoglycaemia may lead to unconsciousness and / or convulsions and may result in transient or permanent impairment of brain function or death.

The frequencies of adverse events from clinical studies, considered as attributable to Actrapid, are listed below. Frequencies are defined as follows: infrequent (≥ 1/1000 to <1/100). Spontaneous isolated cases are considered very rare (<1 / 10, 000), including isolated cases.

Within each group frequency, adverse effects should be presented in order of decreasing severity.

Nervous system disorders

Uncommon - Peripheral Neuropathy

A rapid improvement in glycemic control may be associated with a condition called "acute pain neuropathy", which is usually reversible.

Eye disorders

Uncommon - refraction anomalies

Anomalies of refraction may occur at the beginning of insulin therapy. These symptoms are usually transient.

Very rare - Diabetic retinopathy

Improved long-term glycemic control decreases the risk of progression of diabetic retinopathy. However, an intensification of insulin therapy with sudden improvement in glycemic control may be associated with a transient worsening of diabetic retinopathy.

Skin and subcutaneous tissue disorders

Uncommon - Lipodystrophy

The appearance of lipodystrophy at the injection site is possible when the alternation of the injection sites in the same zone is not respected.

General disorders and administration site conditions

Uncommon - Injection Site Reactions

Injection site reactions (redness, swelling, itching, pain and hematoma at the injection site) may occur during insulin therapy. These reactions are usually transient and usually resolve with continued treatment.

Uncommon - edema

Edema may occur at the beginning of insulin therapy. These symptoms are usually transient.

Immune system disorders

Uncommon - Urticaria, rash

Very rare - Anaphylactic reactions

Symptoms of generalized hypersensitivity may include generalized rash, itching, sweating, gastrointestinal disturbances, angioneurotic edema, breathing difficulties, palpitations, low blood pressure, and unconsciousness / unconsciousness. Generalized hypersensitivity reactions may be life-threatening.