EpiPen

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Adrenaline 1 mg/mL

Tillgänglig från:

Viatris Limited

INN (International namn):

Adrenaline 1 mg/mL

Dos:

1 mg/mL

Läkemedelsform:

Solution for injection

Sammansättning:

Active: Adrenaline 1 mg/mL Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium metabisulfite Water

Enheter i paketet:

Cartridge, glass, New Generation Auto-Injector 2mL, giving 0.3mL dose, 1 dose unit

Klass:

Restricted

Receptbelagda typ:

Restricted

Tillverkad av:

Boehringer Ingelheim Pharma GmbH & Co KG

Terapeutiska indikationer:

The emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings or bites, foods, drugs or other allergens.

Produktsammanfattning:

Package - Contents - Shelf Life: Cartridge, glass, New Generation Auto-Injector 2mL, giving 0.3mL dose - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, New Generation Auto-Injector 2mL, giving 0.3mL dose - 2 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, spring loaded inj. device - 0.3 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Excursions permitted to 15°C

Tillstånd datum:

1996-07-08

Bipacksedel

Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
EPIPEN
Ò
_ADRENALINE (EPINEPHRINE)* 300 ΜG/0.3 ML AUTO-INJECTOR_
_* In some countries, adrenaline is known as epinephrine_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EpiPen Adrenaline
Auto-Injector. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you
receiving EpiPen against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST BEFORE
THERE IS A SITUATION WHERE EPIPEN
IS NEEDED.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE AN EMERGENCY ARISES.
Keep this leaflet safely, with the
EpiPen Auto-Injector. You will
probably want to read it again.
WHAT EPIPEN IS
USED FOR
EpiPen is only to be used for the
immediate EMERGENCY
TREATMENT of a SEVERE
ALLERGIC REACTION (also known
as ANAPHYLAXIS). Your doctor or
pharmacist will explain what this is
like, so that you know when you
must use EpiPen.
EpiPen is used to treat people who
have a severe allergic reaction
caused by, for example,
hypersensitivity to
•
FOOD
•
MEDICINES
•
STINGING INSECTS
•
INSECT BITES
•
LATEX OR
•
OTHER ALLERGENS, POSSIBLY
UNIDENTIFIED.
See Side effects for information
regarding allergy to sodium
metabisulfite.
AVOIDANCE OF KNOWN ALLERGENS IS
MOST IMPORTANT IN PREVENTING
SEVERE ALLERGIC REACTIONS.
A severe allergic reaction, otherwise
known as anaphylaxis, is
overwhelming and life-threatening.
It affects the whole body, in
particular the
•
heart and blood circulation.
This may cause, for
example, low blood
pressure and collapse, or
abnormal heart beat or
function.
•
air passages and lungs.
This causes difficulty in
breathing, with noisy
wheezing or gasping,
possibly with sneezing and
a very runny nose.
•
stomach and bowels.
This may cause nausea,
vomiting, diarrhoea and
abdominal cramps, often
severe.
•
s

Produktens egenskaper

Page 1 of 9
NEW ZEALAND DATA SHEET EPIPEN
®
1. PRODUCT NAME
EPIPEN 300 µg Adrenaline (epinephrine*) Auto-Injector
* in some countries, adrenaline is known as epinephrine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
auto-injector
delivers
a
single
300
microgram
(µg)
intramuscular
dose
of
adrenaline
(epinephrine) from Adrenaline Injection 1:1,000 USP (0.3 mL).
Excipient(s) with known effect: contains sulfites.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in an auto-injector (prefilled, disposable
automatic injection device) for
intramuscular use. The injection is a clear, colourless solution.
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_
DOSE
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 mL, 1:1000).
Children (15 to 30 kg): Intramuscular injection of EPIPEN
JR.Auto-Injector containing 0.15 mg
adrenaline injection (0.3 mL, 1:2000).
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).
Page 2 of 9
METHOD OF ADMINISTRATION
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