Medicinal Products

ANAPEN 0.3 mg / 0.3 mL

Generic drug of the therapeutic class: Allergology
Active ingredients: Adrenaline
laboratory: Bioprojet Pharma

Injectable solution
Box of 2 pre-filled syringes of 0.3 mL
All forms

Indication

Emergency treatment of symptoms of anaphylactic shock caused by peanuts or other foods, drugs, insect bites or stings, other allergens, as well as idiopathic or exercise-induced anaphylactic shock.

Dosage ANAPEN 0.3 mg / 0.3 mL Solution for injection Box of 2 pre-filled syringes 0.3 mL

Intramuscular use only.

ANAPEN consists of a pre-filled syringe of adrenaline contained in a self-injection device. All is an auto-injector.

The injection of ANAPEN must be performed intramuscularly, without waiting, as soon as the precursor signs and symptoms of anaphylactic shock appear. These can occur within minutes of exposure to the allergen. They are most often manifested by urticaria, hot flashes or angioedema. More severe reactions may affect the circulatory and pulmonary systems.

Inject ANAPEN only in the anterolateral aspect of the thigh and not in the gluteal muscle. The injection area can be massaged lightly for 10 seconds after administration.

The usual effective dose is between 0.005 to 0.01 mg / kg, but higher doses may be necessary in some cases.

Use in adults:

The usual dose is 300 micrograms.

An additional injection may be necessary in patients with high weight.

Under certain circumstances, a single dose of adrenaline may not be enough to reverse the effects of an acute allergic reaction. In these patients, a new dose can be injected after a delay of 10 to 15 minutes.

Use in children:

The appropriate dose is 150 micrograms (ANAPEN 0.15 mg / 0.3 ml) or 300 micrograms (ANAPEN 0.30 mg / 0.3 ml) of adrenaline depending on the child's body weight and the doctor's decision .

The 0.15 mg / 0.3 ml ANAPEN auto-injector is designed to deliver a single dose of 150 micrograms of adrenaline.

The use is not recommended in children weighing less than 15 kg except in case of vital risk or decision of the doctor; a dose less than 150 micrograms of adrenaline can not be precisely administered in these children.

A package of two auto-injectors is available in some countries.

The 0.30 mg / 0.3 ml ANAPEN auto-injector is intended for immediate self administration by a person with a history of anaphylactic reaction. It is designed to deliver a single dose of 300 micrograms (0.3ml) of adrenaline. For stability reasons, a volume of 0.75 ml remains unused in the syringe after use. However, the device must not be reused and must be disposed of with the necessary safety precautions.

Against indications

Hypersensitivity to adrenaline or any of the excipients (see Warnings and Precautions for more information on sulphites).

Adverse effects Anapen

Adverse effects depend on the patient's individual sensitivity and the dose administered.

At low doses, common side effects are: palpitations, tachycardia, sweating, nausea, vomiting, difficulty breathing, pallor, dizziness, weakness, tremors, headache, anxiety, nervousness, anxiety, cold extremities.

The less common effects are: hallucinations, syncope, hyperglycemia, hypokalemia, metabolic acidosis, mydriasis, urinary difficulty with urinary retention, muscle tremors.

In high doses or in patients sensitive to adrenaline, the adverse effects are: cardiac arrhythmia (ventricular fibrillation / cardiac arrest), access to arterial hypertension (sometimes causing cerebral hemorrhage), or even vasoconstriction (for example cutaneous, mucous membranes and kidneys).

ANAPEN contains sodium metabisulphite and can cause allergic-type reactions including anaphylactic symptoms and even a life-threatening risk. Severe asthma attacks in some sulphite-sensitive patients may also occur.

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