Medicinal Products

EPIPEN 0.15 mg / 0.3 mL

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

Injectable solution
Box of 2 0.3 ml pre-filled pens
All forms

Indication

EPIPEN (epinephrine) auto-injectors are indicated for the emergency treatment of severe allergic reactions (anaphylactic shock) caused by e.g. by insect bites or stings, foods, drugs or other allergens, as well as in the treatment of idiopathic or exercise-induced anaphylactic shock.

EPIPEN Auto-Injectors are intended for immediate administration in patients who have a high risk of severe allergic reaction, including those with a history of anaphylactic reactions.

Dosage EPIPEN 0.15 mg / 0.3 mL Solution for injection Box of 2 0.3 ml pre-filled pens

Dosage

Pediatric population:

· Children and adolescents over 30 kg *:

The usual dose is 300 micrograms intramuscularly.

* For these patients the EPIPEN auto-injector containing 300 micrograms adrenaline per dose is available.

· Children between 15 kg and 30 kg:

The usual dose is 150 micrograms intramuscularly.

· Children under 15 kg:

A dose of less than 150 micrograms can not be given with sufficient precision in children under 15 kg; therefore, use is not recommended unless there is a life-threatening or doctor's decision.

The usual pediatric dose for the emergency treatment of an allergic reaction is 150 micrograms of intramuscular adrenaline, based on the patient's body weight (0.01 mg / kg). However, the doctor may prescribe higher or lower doses based on the careful evaluation of each patient and the consideration of the threat to the vital risk of the reactions for which this treatment is described. The doctor should consider using other forms of injectable adrenaline if lower doses are needed for small children.

Adults:

The usual dose is 300 micrograms intramuscularly.

The initial injection should be performed as soon as the symptoms of anaphylactic shock appear.

A second injection with a new EPIPEN 0.15 mg / 0.3 ml autoinjector may be required 5 to 15 minutes after the first injection, in the absence of clinical improvement or if symptoms worsen.

The patient must consult a doctor after administration in order to benefit from medical supervision and / or additional treatment.

The doctor who prescribes an EPIPEN 0.15 mg / 0.3 ml auto-injector solution for injection in a pre-filled pen must ensure that the patient understands the indications and the method of administration perfectly.

The doctor should therefore inform the patient in detail on the package leaflet, the instructions for use of the auto-injector and the possible symptoms of anaphylactic shock.

Administration mode

The administration must be done intramuscularly in the anterolateral aspect of the thigh, not in the buttocks. It can be practiced through clothing or directly in contact with the skin.

See section Instructions for use, handling and disposal Special precautions for disposal and other handling.

Against indications

There is no known absolute contraindication to the use of EPIPEN in an allergic emergency.

Epipen side effects

Adrenaline-related adverse effects of alpha and beta receptors may include symptoms such as tachycardia and hypertension, as well as adverse effects on the central nervous system.

The frequency of adverse reactions is assessed as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare ( ≥ 1/10 000 to <1/1 000), very rare (<1 / 10, 000), unknown (can not be estimated from the available data).

Classes of organ systems

Frequency

Undesirable effect

Psychiatric disorders

unknown

Anxiety

Nervous system disorders

unknown

Headache, dizziness, tremors

Heart conditions

Rare

Stress cardiomyopathy

unknown

Tachycardia, cardiac arrhythmia

Vascular disorders

unknown

Hypertension, peripheral ischemia following accidental injection into the hands or feet

Gastrointestinal disorders

unknown

Nausea, vomiting

Skin and subcutaneous tissue disorders

unknown

Hyperhidrosis

General disorders and administration site conditions

unknown

Asthenia

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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