EPINEPHRINE INJECTION MYLAN JR 0.15 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EPINEPHRINE

Available from:

TRUPHARM MARKETING 1985 LTD.

ATC code:

R01AA14

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPINEPHRINE 0.15 MG / 0.3 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

MERIDIAN MEDICAL TECHNOLOGIES INC., USA

Therapeutic area:

EPINEPHRINE

Therapeutic indications:

Epinephrine is indicated in the emergency treatment of severe allergic reactions (Type I) 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, foods, drugs,diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise induced anaphylaxis.Epinephrine 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.Epinephrine is intended for immediate administration as emergency supportive therapy only, and is not a substitute for immediate medical care

Authorization date:

2023-12-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY
EPINEPHRINE INJECTION MYLAN 0.3 MG
EPINEPHRINE INJECTION MYLAN JR 0.15 MG
SOLUTION FOR INJECTION WITH AUTO-INJECTOR
ACTIVE INGREDIENT
EPINEPHRINE INJECTION MYLAN 0.3 MG contains one dose of 0.3 mg
epinephrine (0.3
mL) in a sterile solution.
(epinephrine 0.3 mg/0.3 mL)
EPINEPHRINE INJECTION MYLAN JR 0.15 MG 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?
Epinephrine Injection Mylan 0.3 mg / Epinephrine Injection Mylan Jr
0.15 mg 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.
Epinephrine Injection Mylan 0.3 mg / Epinephrine Injection Mylan Jr
0.15 mg are for immediate
administration in patients who are determined to be at increased ri

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
EPINEPHRINE INJECTION MYLAN 0.3 MG
EPINEPHRINE INJECTION MYLAN JR 0.3 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EPINEPHRINE INJECTION MYLAN 0.3 MG: 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.
EPINEPHRINE INJECTION MYLAN JR 0.15 MG: 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
Epinephrine Injection Mylan and Epinephrine Injection Mylan 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.
Epinephrine Injection Mylan and Epinephrine Injection Mylan 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.
Epinephrine Injection Mylan and Epinephrine Injection Mylan Jr are
intended for imme