PHARMACEUTICAL FORMSolution for injection in an automatic injector (disposable and pre-filled automatic injection device) for intramuscular use.
Clear and colorless solution. DOSAGEThe Epipen Jr. automatic injector is for pediatric intramuscular administration. It is designed to facilitate use by the layman and has to be considered as first aid. The Epipen Jr. automatic injector provides a 0.3 ml single dose injection equal to 0.15 mg adrenaline when activated. For pediatric use, the appropriate dose may be 0.15 mg or 0.3 mg depending on the patient's body weight (0.01 mg / kg body weight). The Epipen Jr. 0.15 mg auto injector is recommended for children between 7.5 and 25 kg. For children weighing more than 25 kg, Epipen auto injector 0.3 mg (formulation for adults) is recommended.
ADMINISTRATIONInject the administered dose of the Epipen Jr. automatic injector (0.3 mL equal to 0.15 mg) into the anterolateral side of the thigh, through clothing if necessary.
The patient / caregiver should be informed that after each use of the Epipen Jr. automatic injector:
SPECIAL PRECAUTIONS FOR ELIMINATIONDo not remove the blue safety cap until ready to use. Under no circumstances place the orange end of the Epipen Jr. automatic injector on or near the thumbs, fingers or hands. An accidental injection into the hand or finger resulting in peripheral ischemia has been reported.
The Epipen Jr. automatic injector should be used on the outer thigh. The injector activates immediately once the orange end of the Epipen Jr. automatic injector comes into contact with any skin or other surface. The Epipen Jr. automatic injector should simply be struck firmly against the outside of the thigh at a distance of approximately 10 cm. There is no need for more precise placement on the outside of the thigh.
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THERAPEUTIC INDICATIONSEpipen Jr. auto injectors are automatic injection devices that contain adrenaline for allergic emergencies. The automatic injector is designed for children with a body weight of 7.5-25 kg. Automatic injectors should only be used by a person with a history or recognized risk of an anaphylactic reaction. Automatic injectors are indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect bites or stings, food, drugs and other allergens, as well as idiopathic or exercise induced anaphylaxis. These reactions can occur minutes after exposure and consist of redness, apprehension, syncope, tachycardia, chronic or unreachable pulse associated with a drop in blood pressure, seizures, vomiting, diarrhea and abdominal cramps, involuntary urination, wheezing, spastic dyspnea Laryngeal, itching, rash, urticaria or angioedema.
WARNINGSThere is a risk of adverse reactions following the administration of adrenaline in patients with high intraocular pressure, severe renal insufficiency, prosthetic adenoma leading to residual urine, hypercalcemia and hypokalemia. In patients with Parkinson's disease, adrenaline may be associated with a transient worsening of Parkinson's symptoms such as stiffness and tremor. The use of adrenaline with drugs that can sensitize the heart to arrhythmias, for example, digitalis, mercurial diuretics or quinidine, is not usually recommended. Anginal pain can be induced by adrenaline in patients with coronary insufficiency. Hyperthyroid individuals (hyperfunction of the thyroid gland), individuals with cardiovascular disease, hypertension (high blood pressure) or diabetes, the elderly, pregnant women and children under 7.5 kg body weight using the automatic injector Epipen Jr. can theoretically be at risk of developing adverse reactions after administration of epinephrine.
NATURE AND CONTENTS OF PACKAGINGThe glass cartridge contains product.
The automatic injector management device:
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Download the product specification for more information.
ficha_tecnica_epipen_jr.pdf | |
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