EPIPEN 0.3mg/0.3mL injection syringe auto-injector

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adrenaline (epinephrine), Quantity: 1 mg/mL

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium metabisulfite; water for injections; hydrochloric acid

Administration route:

Intramuscular

Units in package:

2mL X 1, 2mL X 2

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the emergency treatment of anaphylactic reactions to insect stings through immediate self administration by individuals with a history of hypersensitivity to insect stings. EpiPen and EpiPen Jr. are designated as emergency supportive therapy only and are not a replacement or substitute for subsequent medical or hospital care, nor are they intended to supplant insect venom hyposensitization. INDICATIONS AS AT 17 JUNE 2003: For the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens For the emergency treatment of anaphylactic reactions to insect stings through immediate self administration by individuals with a history of hypersensitivity to insect stings. EpiPen and EpiPen Jr. are designated as emergency supportive therapy only and are not a replacement or substitute for subsequent medical or hospital care, nor are they intended to supplant insect venom hyposensitization. INDICATIONS AS AT 17 JUNE 2003: For the emergency treatment of anaphylax

Product summary:

Visual Identification: Clear, colourless liquid.; Container Type: Syringe; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1993-08-20

Patient Information leaflet

EPIPEN ®
1
EPIPEN®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING EPIPEN?
EPIPEN contains the active ingredient adrenaline (epinephrine). In
some countries, adrenaline is known as epinephrine. EPIPEN is
only to be used for the immediate EMERGENCY TREATMENT of a SEVERE
ALLERGIC REACTION (also known as ANAPHYLAXIS).
For more information, see Section 1. Why am I using EPIPEN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPIPEN?
EPIPEN is a life-saving treatment in the emergency management of
severe allergic reactions. Therefore, it should not be withheld
from anyone who is considered to need it. TALK TO YOUR DOCTOR IF YOU
HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
EPIPEN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with EPIPEN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE EPIPEN?
•
EPIPEN delivers one measured dose of adrenaline intended for a person
who weighs more than 30 kg. It may be prescribed
for a child who weighs from 15 kg up to 30 kg.
More instructions can be found in Section 4. How do I use EPIPEN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EPIPEN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
EPIPEN.
•
Check the expiry date on EPIPEN and request for replacement prior to
the expiry date.
THINGS YOU
SHOULD NOT DO
•
Do not use EPIPEN to treat any other medical conditions including
other types of shock unless
advised by the doctor.
•
Do not use EPIPEN if the solution is cloudy, coloured, contains
sediment or the viewing window is
obscured.
•
Do not take off the blue safety release until required.
•
Do not tou

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
EPIPEN
®
_Adrenaline (epinephrine)* _
1
NAME OF THE MEDICINE
_* In some countries, adrenaline is known as epinephrine. _
Adrenaline (epinephrine)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EPIPEN Adrenaline (epinephrine) injection contains adrenaline
(epinephrine) 300 micrograms in 0.3 mL as the
active ingredient.
Excipients with known effect: Contains sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clear, colourless liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the emergency treatment of anaphylaxis (acute severe allergic
reactions) due to insect stings, or bites, foods,
drugs or other allergens.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE: _
Selection of the appropriate dosage strength is determined according
to patient body weight and this decision
should be based on careful assessment of the individual patient and
recognition of the life-threatening nature of
reactions for which EPIPEN is prescribed.
Adults (

30 kg): Intramuscular injection of EPIPEN Auto-Injector containing 0.3
mg adrenaline injection (0.3
mg/0.3 mL)
Children (15 to 30 kg): Intramuscular injection of EPIPEN JR
Auto-Injector containing 0.15 mg adrenaline
injection (0.15 mg/0.3 mL)
The doctor or pharmacist may choose to recommend more or less than
this amount*. With severe persistent
anaphylaxis, repeat injections with an additional EPIPEN Auto-Injector
may be necessary.
To manage severe anaphylaxis, repeat EPIPEN injections may be
necessary. Each EPIPEN Auto-Injector is used
once only. The EPIPEN dose may be repeated every 5 to 15 minutes if
symptoms recur or have not subsided
(see
SECTION 4.9 OVERDOSE
).
_Use of Adrenaline: _
1.
Before using, check to make sure the solution in the Auto-Injector is
not brown in colour. If it is
discoloured or contains a precipitate, do not use, since these changes
indicate that the effectiveness of the
drug product may be decreased.
2.
The delivered dose of the EPIPEN Auto-Injector should be injected
int