EPIPEN JR

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

EPINEPHRINE

متاح من:

TRUPHARM MARKETING 1985 LTD.

ATC رمز:

C01CA24

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

EPINEPHRINE 0.5 MG / 1 ML

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MERIDIAN MEDICAL TECHNOLOGIES INC., USA

المجموعة العلاجية:

EPINEPHRINE

المجال العلاجي:

EPINEPHRINE

الخصائص العلاجية:

EpiPen Jr is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.EpiPen Jr is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. EpiPen Jr is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

تاريخ الترخيص:

2021-08-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY
EPIPEN / EPIPEN JR
AUTO-INJECTOR
ACTIVE INGREDIENTS
EpiPen contains one dose of 0.3 mg epinephrine (0.3 mL) in a sterile
solution
(epinephrine 0.3 mg/0.3 mL)
EpiPen Jr: contains one dose of 0.15 mg epinephrine (0.3 mL) in a
sterile solution
(epinephrine 0.15 mg/0.3 mL)
Inactive ingredients and allergens: See section 6 ‘Additional
information’.
READ THE ENTIRE PATIENT LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further
questions, consult your doctor or pharmacist.
Read this leaflet carefully each time you purchase a new
auto-injector. The leaflet may have
new information. Make sure that you, your parents or caregiver
understand the indications and
the right way of using the auto-injector before a severe allergic
reaction occurs – anaphylaxis.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
EpiPen and EpiPen Jr are indicated in the emergency treatment of
severe allergic reactions
(Type 1), including anaphylaxis to stinging insects (e.g., order
Hymenoptera, which includes,
bees, wasps, hornets, yellow jackets and fire ants) and biting insects
(e.g., triatoma,
mosquitoes), allergen immunotherapy, food, drugs, diagnostic testing
substances (e.g.,
radiocontrast media) and other allergens, as well as anaphylaxis due
to an unknown cause
(idiopathic) or exercise-induced anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in
patients who are
determined to be at increased risk for anaphylaxis, including
individuals with a history of
anaphylactic reactions.
EpiPen and EpiPen Jr are intended for immediate administration as
emergency supportive
therapy only and are not a substitute for immediate medical care.
TH

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
EPIPEN
EPIPEN JR
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EPIPEN: PER 0.3 ML:
ACTIVE INGREDIENT
QUANTITY / UNIT
Adrenaline (Epinephrine)
0.3 mg
Excipients with known effect: Sodium metabisulfite 0.5 mg/dose, sodium
chloride 1.8 mg/dose.
For a full list of excipients, see section 12.
EPIPEN JR: PER 0.3 ML:
ACTIVE INGREDIENT
QUANTITY / UNIT
Adrenaline (Epinephrine)
0.15 mg
Excipients with known effect: Sodium metabisulfite 0.5 mg/dose, sodium
chloride 1.8 mg/dose.
For a full list of excipients, see section 12.
PHARMACEUTICAL FORM
Solution for injection in an auto-injector (prefilled, disposable
automatic injection device) for
intramuscular use.
Clear and colourless solution.
3.
INDICATIONS AND USAGE
EpiPen and EpiPen Jr are indicated in the emergency treatment of
severe allergic reactions (Type I)
including anaphylaxis to stinging insects (e.g., order Hymenoptera,
which include bees, wasps,
hornets, yellow jackets and fire ants) and biting insects (e.g.,
triatoma, mosquitoes), allergen
immunotherapy, foods, drugs, diagnostic testing substances (e.g.,
radiocontrast media) and other
allergens, as well as idiopathic anaphylaxis or exercise-induced
anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in
patients who are determined to be at
increased risk for anaphylaxis, including individuals with a history
of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and
consist of flushing, apprehension,
syncope, tachycardia, thready or unobtainable pulse associated with a
fall in blood pressure, convulsions,
vomiting, diarrhea and abdominal cramps, involuntary voiding,
wheezing, dyspnea due to laryngeal
spasm, pruritus, rashes, urticaria or angioedema.
EpiPen and EpiPen Jr are intended for immediate administration as
emergency supportive therapy only
2
and are not a substitute for immediate medical care.
4.
DOSAGE AND ADMINISTRATION
Selection of the appropriate dosage strength (EpiPen 0.3 mg or EpiPen
Jr 0.15 mg) is determined
a