Medicinal Products

ACTRAPID NovoLet 100 IU / ml

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

Injectable solution
Box of 5 pre-filled pens of 3 ml
All forms

Indication

Diabetes treatment.

Dosage ACTRAPID NovoLet 100 IU / ml Solution for injection Box of 5 Pre-filled pens 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. It is recommended to monitor blood glucose carefully.
- An injection must be followed, within 30 minutes, of a meal or snack containing carbohydrates.
Dosage adjustment:
Concomitant illnesses, 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 section on warnings and precautions for use).
Administration:
- Subcutaneously.
- Actrapid is usually 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 skinfold 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.
To avoid lipodystrophy, injection sites should be alternated within the same body region.
- Intravenous administration of Actrapid from a pen or cartridge should be an exception in situations where vials are not available. In this case, Actrapid should be aspirated into an insulin syringe, so air injection is avoided, or infused through an infusion system.
- Actrapid is accompanied by a leaflet whose instructions must be followed.
- Actrapid NovoLet is intended for use with NovoFine needles.
NovoLet can inject from 2 to 78 units in increments of 2 units.
- Air must be removed from the pen before each injection, until the dose selector returns to zero and a drop of insulin appears at the tip of the needle.
To select the dose, turn the dose selector, which returns to zero during injection.

Against indications

- Hypersensitivity to human insulin or to any of the excipients.
- Hypoglycemia.
Because of the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous infusion.

Actrapid Novolet side effects

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 reactions from clinical studies, considered as attributable to fast-acting insulin, Actrapid, are listed below. The frequencies are defined as follows: infrequent (> 1/1000, <1/100). Spontaneous isolated cases are considered very rare (<1/10000).
- 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.
- disorders of the nervous system :
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 - Anomalies of refraction.
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 anomalies at the site of administration :
. 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.
. Very rare - Edema.
Edema may occur at the beginning of insulin therapy. These symptoms are usually transient.

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