Active ingredients: Adrenaline
FASTJEKT - Solution for injection for intramuscular use
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FASTJEKT INJECTABLE SOLUTION FOR INTRAMUSCULAR USE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient contained in 1 ml: Adrenaline
FASTJEKT
330 mcg
1100 mcg
FASTJEKT
165 mcg:
550 mcg
For excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Injectable solution.
FASTJEKT 330 mcg is an intramuscular pre-filled injector, with which a single dose of solution (0.30 ml) containing 330 mcg of adrenaline is injected. FASTJEKT 165 mcg is an intramuscular pre-filled injector, with which a single dose of solution (0.30 ml) containing 165 mcg of adrenaline is injected.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Emergency treatment of allergic reactions to insect bites, foods, drugs and other allergens in patients at known risk of anaphylactic shock. FASTJEKT is a first aid product and does not replace subsequent medical treatment.
04.2 Posology and method of administration
FASTJEKT 330 mcg delivers a single dose of 0.30 ml of solution, containing 330 mcg of adrenaline.
FASTJEKT 165 mcg delivers a single dose of 0.30 ml of solution, containing 165 mcg of adrenaline.
When prescribing the product the doctor must consider the following points:
The normal dosage of adrenaline is 10 mcg / kg
Kg of weight mcg of adrenaline
10 kg 100 mcg
15 kg 150 mcg
30 kg 300 mcg
50 kg 500 mcg
The maximum recommended single dose of adrenaline corresponds to 300-500 mcg for adults, and 300 mcg for children, possibly repeatable if necessary after 10 - 15 minutes
FASTJEKT 330 mcg is generally indicated for subjects weighing 30 kg or more
FASTJEKT 165 mcg is generally indicated for subjects weighing less than 30 kg
In the opinion of the doctor FASTJEKT 330 mcg can also be prescribed to subjects weighing less than 30 kg, when they are subjects at high risk of a severe course.
If doses other than those delivered by FASTJEKT are indicated, the doctor should consider other forms of injectable adrenaline.
Act quickly and decisively (see instructions for use). Anaphylactic shock can occur a few seconds or several minutes after the introduction of the allergen; typical warning signs are: burning, warmth, itching above and below the tongue, in throat and especially on the palms and soles of the feet.
Instructions for Use:
FASTJEKT is ready for use and can be used, where possible, after disinfection of the injection point:
1-Remove the blue cap.
2- Take FASTJEKT in your hand holding the orange plastic end in contact with the thigh and press firmly on the skin: you will hear the click of the needle.
3-Hold FASTJEKT in this position for at least ten seconds, until the needle has penetrated the skin and the adrenaline has been injected. Once the injection is complete the window on the auto injector will darken. In no case remove FASTJEKT from the thigh before the end of the injection.
4-Then move FASTJEKT away from the thigh, the orange plastic end will automatically stretch to cover the needle. Massage the injection site for about 10 seconds.
See a doctor as soon as possible with the FASTJEKT used.
FASTJEKT may contain a small nitrogen bubble that forms during the filling process.
All the cartridges are checked during the filling phase and a second check is carried out on the assembled injectors; during these checks, cartridges with bubbles with a diameter greater than 10 mm and injectors in which the bubbles extend below the neck of the cartridge are rejected.
It is therefore normal to have a small bubble which, holding FASTJEKT with the tip upwards, remains in the neck of the auto-injector (the upper part where the needle is inserted).
The small nitrogen bubble does not constitute a danger to the patient's health as:
• The bubble does not affect the amount of solution that is injected;
• The auto-injector is used intramuscularly in the thigh muscle, not by intravenous injection;
• Only 0.3 ml are injected and the correct use of the injector in a perpendicular position to the thigh should normally cause any bubble to float towards the piston on the bottom of the injector, far from the point of insertion of the needle;
• In the extremely rare event that nitrogen is injected into muscle tissue, the human body is able to absorb the small amount of gas without any difficulty.
N.B. For its correct operation, the injector is filled with a quantity of liquid (2.05 ml) clearly higher than that to be injected; therefore it is completely normal that after use most of the solution remains in the injector.
The patient / carer should be informed that after each use of Fastjekt:
• They should immediately seek medical attention, call an ambulance for "anaphylaxis" even if symptoms appear to have improved (see section 4.4).
• Conscious patients should preferably lie down with their feet raised or seated if they have difficulty breathing. Unconscious patients should be turned on their side in a safe lateral position.
• Patients should if possible remain with another person until medical assistance arrives.
04.3 Contraindications
FASTJEKT should not be used in the presence of: arterial hypertension, thyrotoxicosis, pheochromocytoma, paroxysmal tachycardia, tachyarrhythmia, coronary and heart disease, sclerotic changes of the vessels, cor pulmonale, severe renal disorders, narrow angle glaucoma, prostate adenoma. Particular caution is required in case of uncontrolled diabetes, hypercalcemia, hypokalaemia, in elderly patients and in patients with elevated sympathetic tone. FASTJEKT should not be administered concomitantly with beta-blockers or sympathomimetics. Do not use FASTJEKT in the presence of non-anaphylactic shock.
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Particular caution is required in case of uncontrolled diabetes, hypercalcemia, hypokalaemia, in elderly patients and in patients with elevated sympathetic tone.
1. The physician prescribing the use of FASTJEKT must ensure that the patient understands how to use the pre-filled injector when needed and is aware of the symptoms of an allergic reaction which may herald anaphylactic shock.
2. The dose of adrenaline is automatically injected intramuscularly, by pressing on the outer side of the thigh at the point corresponding to the height of the outstretched arm (see instructions for use). Applying FASTJEKT on the thigh avoids the danger of inadvertent injection by the vascular route. Do not inject into the buttocks or other parts of the body. Absolutely avoid an intravenous injection.
3. FASTJEKT is for single use only.
4. The blue cap serves as protection to prevent inadvertent discharge of the adrenaline solution. Removing it, the injector is ready for use: the needle inside the orange plastic cap is activated by pressing the injector onto the thigh. A slight noise signals the needle coming out. FASTJEKT is not a substitute for medical treatment! The patient must inject himself or be injected with adrenaline by a companion, and immediately go to an emergency room. After use, the patient should consult a doctor immediately. The patient should also make sure every 15 days that the adrenaline solution is colorless. If the solution is discolored, or even in the presence of a precipitate, it should not be used. The product contains sodium metabisulfite; this substance can cause allergic reactions and severe asthmatic attacks in sensitive subjects and particularly in asthmatics.
The patient / caregiver should be informed about the possibility of biphasic anaphylaxis which is characterized by an initial resolution followed by a recurrence of symptoms several hours later.
Patients with concomitant asthma may have an increased risk of experiencing a severe anaphylactic reaction.
Patients should be warned about related allergens and should be screened whenever possible so that their specific allergens can be characterized.
04.5 Interactions with other medicinal products and other forms of interaction
The hypoglycemic action of antidiabetic drugs can be reduced by the administration of adrenaline. An increase in heart rhythm disturbances can be determined by the concomitant administration of halothane, cyclopropane and digitalis. The sympathomimetic effect of adrenaline can be enhanced by the concomitant administration of inhibitors of the monoamine oxidase, tricyclic antidepressants, guanethidine, reserpine, levothyrosine sodium, some antihistamines such as chlorphenamine, tripelenamine and diphenhydramine. Co-administration of alpha-blockers can lead to the opposite effect of adrenaline (blood pressure lowering). With beta-blockers there is a sharp increase in the hypertensive effect of adrenaline. The simultaneous administration of local anesthetics can produce a reciprocal enhancement of the effect.
04.6 Pregnancy and breastfeeding
As there are no controlled clinical data in pregnant women, FASTJEKT should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. The possible passage of adrenaline into breast milk is irrelevant as the drug is not absorbed orally.
04.7 Effects on ability to drive and use machines
It does not compete.
04.8 Undesirable effects
Palpitations, sweating, nausea, vomiting, difficulty in breathing, paleness, dizziness, tremor, headache, anxious state, heart rhythm disturbances, hyperglycemia. These symptoms usually subside spontaneously without resorting to therapeutic interventions.
04.9 Overdose
In very rare cases, when there is an overdose, in particularly sensitive people or following an incorrect intravenous application, cerebral haemorrhages, ventricular arrhythmias and sometimes renal failure may occur. Against these extremely rare side effects of adrenaline, an alpha-sympatholytic (eg phentolamine) can be applied or a peripheral vasodilator (eg sodium nitroprusside) administered. In the presence of predominantly tachyarrhythmic side effects, the application of a beta-blocker (eg propranolol) is also indicated.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: cardiac stimulants, excluding cardiac, adrenergic and glucosides
Dopaminergics.
ATC code: C01CA24.
Adrenaline is a sympathomimetic hormone whose pharmacology is widely documented in the international literature; in anaphylactic shock caused by insect stings or bites, by foods, drugs or other allergens, intramuscularly injected adrenaline is the drug of first choice as it counteracts the pathogenesis of shock thanks to its relaxing and inhibiting action on the bronchial muscles the release of mediators of the allergic reaction. Adrenaline also has a positive "cardiac batmotropic and positive inotropic action and a" vasoconstrictive action on small blood vessels.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients contained in 1 ml: sodium chloride; sodium metabisulfite; hydrochloric acid; water for injections.
06.2 Incompatibility
It does not compete.
06.3 Period of validity
FASTJEKT 330 mcg solution for injection for intramuscular use.
Validity: 18 months.
FASTJEKT 165 mcg solution for injection for intramuscular use.
Validity: 18 months.
Make sure every 15 days that the adrenaline solution is colorless and that there are no precipitates. In this case FASTJEKT must not be used. The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Adrenaline is sensitive to light and heat.
Store FASTJEKT at a temperature not exceeding 25 ° C. Store in the outer carton to protect from light.
06.5 Nature of the immediate packaging and contents of the package
For both FASTJEKT 330 mcg and FASTJEKT 165 mcg it is a pre-filled injector consisting of: glass syringe (type I) sealed with a rubber plunger on one side and a rubber diaphragm on the other; steel needle protected by a rubber cap The whole system is protected by a plastic coating and, together with the package leaflet, placed in a cardboard box.
FASTJEKT 330 mcg - Solution for injection for intramuscular use. 1 pre-filled injector of 2.05 ml or 2 pre-filled injectors of 2.05 ml;
FASTJEKT 165 mcg - Solution for injection for intramuscular use. 1 x 2.05ml pre-filled injector or 2 x 2.05ml pre-filled injectors
06.6 Instructions for use and handling
See section 4.2 for instructions to be given to the patient / carer regarding the actions to be taken after each use of Fastjekt. Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Meda Pharma S.p.A. Viale Brenta 18 - 20139 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
FASTJEKT "330 mcg solution for injection for intramuscular use". 1 pre-filled injector 2.05 ml AIC n ° 028505016
FASTJEKT "330 mcg solution for injection for intramuscular use" 2 pre-filled injectors of 2.05 ml AIC n ° 028505030
FASTJEKT "165 mcg solution for injection for intramuscular use" 1 pre-filled injector of 2.05 ml A.I.C. n. 028505028
FASTJEKT "165 mcg solution for injection for intramuscular use" 2 pre-filled injectors of 2.05 ml AIC n ° 028505042
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 1995 / November 1999 / November 2004
10.0 DATE OF REVISION OF THE TEXT
February 2015
