EMERADE 150 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EPINEPHRINE AS TARTRATE

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

C01CA24

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPINEPHRINE AS TARTRATE 1 MG / 1 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

RECHON LIFE SCIENCE AB, SWEDEN

Therapeutic area:

EPINEPHRINE

Therapeutic indications:

Emerade 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.Emerade 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. Emerade is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Authorization date:

2019-12-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EMERADE 150 MCG
EMERADE 300 MCG
EMERADE 500 MCG
SOLUTION FOR INJECTION, INTRAMUSCULAR
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The pre-filled pen contains 0.5 ml of epinephrine solution 1 mg/ml.
Emerade 150 mcg delivers a single dose of 0.15 ml containing 150
micrograms of epinephrine tartrate.
Emerade 300 mcg delivers a single dose of 0.3 ml containing 300
micrograms of epinephrine tartrate.
Emerade 500 mcg delivers a single dose of 0.5 ml containing 500
micrograms of epinephrine tartrate.
Each 0.15 ml (150 micrograms) dose contains 0.075 mg sodium
meta-bisulphite (E223).
Each 0.3 ml (300 micrograms) dose contains 0.15 mg sodium
meta-bisulphite (E223).
Each 0.5 ml (500 micrograms) dose contains 0.25 mg sodium
meta-bisulphite (E223)
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled pen (auto-injector).
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emerade 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.
Emerade 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.
Emerade is intended for immediate administration as emergency
supportive therapy only and is not a
substitute for immediate medical care.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The effective dose is usually within the range 5- 10 micrograms per kg
bodyweight but higher doses
may be necessary in some cases.
2
_Paediatric population _
Use in children: Emerade 500 mi