EPIPEN JR 0.15mg/0.3mL injection syringe

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

adrenaline (epinephrine), Quantity: 0.5 mg/mL

Beschikbaar vanaf:

Alphapharm Pty Ltd

farmaceutische vorm:

Injection, solution

Samenstelling:

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

Toedieningsweg:

Intramuscular

Eenheden in pakket:

2mL X 1, 2mL X 2

Prescription-type:

(S3) Pharmacist Only Medicine

therapeutische indicaties:

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.

Product samenvatting:

Visual Identification: clear, colourless liquid; Container Type: Syringe; Container Material: Glass; Container Life Time: 19 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Registered

Autorisatie datum:

1993-08-20

Bijsluiter

EPIPEN JR ®
1
EPIPEN JR®
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 JR?
EPIPEN JR contains the active ingredient adrenaline (epinephrine). In
some countries, adrenaline is known as epinephrine. EPIPEN
JR 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 JR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPIPEN JR?
EPIPEN JR 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 YOUR CHILD HAS ANY OTHER MEDICAL CONDITIONS, OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
EPIPEN JR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with EPIPEN JR 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 JR?
EPIPEN JR delivers one measured dose of adrenaline intended for a
child who weighs 15 kg to 30 kg.
More instructions can be found in Section 4. How do I use EPIPEN JR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EPIPEN JR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
EPIPEN JR.
•
Check the expiry date on EPIPEN JR and request for replacement prior
to the expiry date.
THINGS YOU
SHOULD NOT DO
•
Do not use EPIPEN JR to treat any other medical conditions including
other types of shock unless
advised by the doctor.
•
Do not use EPIPEN JR 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 touch the orange end on any person or object while you are
taking off the blue

Productkenmerken

AUSTRALIAN PRODUCT INFORMATION
EPIPEN
® JR
_Adrenaline (epinephrine)* _
1
NAME OF THE MEDICINE
_* In some countries, adrenaline is known as epinephrine._
Adrenaline (epinephrine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EPIPEN JR Adrenaline (epinephrine) injection contains adrenaline
(epinephrine) 150 micrograms in 0.3mL 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 JR 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 JR
Auto-Injector may be necessary.
Since the dose of adrenaline delivered from an EPIPEN JR Auto-Injector
is fixed, consider using other forms of
injectable adrenaline if doses lower than 0.15 mg are deemed
necessary.
To manage severe anaphylaxis, repeat EPIPEN JR injections may be
necessary. Each EPIPEN JR Auto-Injector
is used once only. The EPIPEN JR dose may be repeated after 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