EpiPen Junior (Epinephrine) Auto-Injector 0.15mgdose (0.5mgml)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Epinephrine

Available from:

GOOD PHARMACEUTICAL PTE. LTD.

ATC code:

C01CA24

Dosage:

0.55mg/ml (includes a 10% overage)

Pharmaceutical form:

INJECTION

Composition:

Epinephrine 0.5 mg/ml

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Meridian Medical Technologies LLC

Authorization status:

ACTIVE

Authorization date:

2007-06-07

Patient Information leaflet

Cyan
Black
Magenta
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APPROVAL MUST BE SENT TO ARTFLO AND ACCT. MANAGER
APPROVED
P/N: EPIPEN_0002188_PI
EVAL#: X5220756
SIZE: 11.0 X 21.875
FOLD: 1.125 X 3.125
DRWG: 120978
IC MARKS: 15, 16, 17, 18, 19
CODE: TYPE / DECODED DATA / HUMAN READABLE
2 OF 5 CODE / 2188 / 2188
CUSTOMER: MERIDIAN
(SIGNATURE / DATE)
by
ART: 19 DATE: 03/23/2023
• CAUTION ARTWORK CYCLES ARE NOT PROOFREAD. PLEASE, PROOFREAD BEFORE
AUTHORIZING NOSCO TO PROCEED TO FINAL PROOFING.
This ART is to show size, copy placement and color breaks. Actual
colors will be matched on press to approved color standards
and/or PMS color swatches. *Customer Logo's, Brand/Drug names with
SUPERSCRIPTS/SUBSCRIPTS WITH ®'S AND TM'S is to be a
minimum 1/32 high for the TM and bold, and for the® 1/32 in
circumference and bold. Any deviation to this will be printed as is.
NOSCO GLUE FLAP BARCODE: IS FOR INTERNAL QUALITY CONTROL PURPOSES ONLY
AND ANY ELEMENT IN DIE COLOR DOES NOT PRINT.
PATIENT INFORMATION
Read this Patient Information leaflet carefully before using
the EpiPen
®
or EpiPen Jr
®
auto-injector and each time you
get a refill. There may be new information. Anyone who may
be able to administer the EpiPen or EpiPen Jr auto-injector
should know how to use it before you have an allergic
emergency.
This information does not take the place of talking with your
healthcare provider about your medical condition or your
treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW
ABOUT EPIPEN AND EPIPEN JR?
1.
EpiPen and EpiPen Jr are single-dose automatic injection
devices
(auto-injectors)
that
contain
epinephrine.
Epinephrine is a medicine used to treat allergic emergencies
(anaphylaxis). Anaphylaxis can be life threatening and
can happen within minutes. If untreated, anaphylaxis
can lead to death. This allergic emergency can be caused
by stinging and biting insects, allergy injections, foods,
medicines, exercise, or unknown causes.
Symptoms of anaphylaxis may include:
•
trouble breathing
•
wheezing
•
hoarseness (changes in the way your v

Summary of Product characteristics

Black
APPROVAL MUST BE SENT TO ARTFLO AND ACCT. MANAGER
APPROVED
P/N: EPIPEN_0002199_PI
EVAL#: X5309938
SIZE: 11.0 X 21.875
FOLD: 1.125 X 3.125
DRWG: 120978
CODE: TYPE / DECODED DATA / HUMAN READABLE
2 OF 5 CODE / 2199 / 2199
REFERENCE MARKS: 7 AND 10
ART: 4 DATE: 03/06/2023
CUSTOMER: MERIDIAN
(SIGNATURE / DATE)
by
• CAUTION ARTWORK CYCLES ARE NOT PROOFREAD. PLEASE, PROOFREAD BEFORE
AUTHORIZING NOSCO TO PROCEED TO FINAL PROOFING.
This ART is to show size, copy placement and color breaks. Actual
colors will be matched on press to approved color standards
and/or PMS color swatches. *Customer Logo's, Brand/Drug names with
SUPERSCRIPTS/SUBSCRIPTS WITH ®'S AND TM'S is to be a
minimum 1/32 high for the TM and bold, and for the® 1/32 in
circumference and bold. Any deviation to this will be printed as is.
NOSCO GLUE FLAP BARCODE: IS FOR INTERNAL QUALITY CONTROL PURPOSES ONLY
AND ANY ELEMENT IN DIE COLOR DOES NOT PRINT.
FULL PRESCRIBING INFORMATION
2199
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
EpiPen and EpiPen Jr are indicated in the emergency treatment of
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.
EpiPen and EpiPen 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.
EpiPen and EpiPen