EpiPen 300 mikrogram Injektionsvätska, lösning i förfylld injektionspenna

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

adrenalin

Saadav alates:

Paranova Läkemedel AB

ATC kood:

C01CA24

INN (Rahvusvaheline Nimetus):

adrenaline

Annus:

300 mikrogram

Ravimvorm:

Injektionsvätska, lösning i förfylld injektionspenna

Koostis:

natriummetabisulfit Hjälpämne; adrenalin 0,3 mg Aktiv substans

Retsepti tüüp:

Receptbelagt

Volitamisolek:

Avregistrerad

Loa andmise kuupäev:

2017-11-15

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPIPEN 300 MICROGRAMS, SOLUTION FOR INJECTION IN PRE-FILLED PEN
Adrenaline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What EpiPen is and what it is used for
2.
What you need to know before you use EpiPen
3.
How to use EpiPen
4.
Possible side effects
5.
How to store EpiPen
6.
Contents of the pack and other information
1.
WHAT EPIPEN IS AND WHAT IT IS USED FOR
EpiPen is a sterile solution
in pre-filled pen
for emergency injection into the muscle (intramuscular).
EpiPen (adrenaline) Auto-Injectors are to be used in the emergency
treatment of severe allergic reactions
(anaphylaxis) caused by allergens in e.g. foods, drugs, insect stings
or bites as well as triggered by exercise
or by unknown causes.
EpiPen Auto-Injectors 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.
Symptoms that signal the onset of an anaphylactic reaction include:
itching of the skin; raised rash (like a
nettle rash); flushing; swelling of the lips, throat, tongue, hands
and feet; wheezing; hoarseness; nausea;
vomiting; abdominal cramps and in some cases, loss of consciousness.
The medicine in the Auto-Injector (the pen) is adrenaline which is an
adrenergic drug.
It works directly on the cardiovascular (heart and circulation) system
and respiratory (lung) system,
countering the potentially fatal effects of anaphylaxis by rapidly
constricting the b

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EpiPen 300 micrograms, solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 1 mg adrenaline (epinephrine). A single dose (0.3 ml)
contains 300 micrograms
(0.3 mg) adrenaline.
Excipient: Sodium Metabisulfite (E223) 0.5 mg/dose, sodium chloride
1.8 mg/dose.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (Auto-Injector).
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EpiPen (adrenaline) Auto-Injectors are indicated in the emergency
treatment of severe allergic
reactions (anaphylaxis) to insect stings or bites, foods, drugs and
other allergens, as well as
idiopathic or exercise induced anaphylaxis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
Usual paediatric dose is 0.01 mg/kg body weight. However, the
prescribing physician has the
option of prescribing more or less than these amounts based on careful
assessment of each
individual patient and recognizing the life-threatening nature of
reactions for which this is
being described. A dosage below 150 micrograms cannot be administered
with EpiPen
adrenaline Auto-Injector. The physician should consider using other
forms of injectable
adrenaline if lower doses are felt to be necessary for small children.
_Children and adolescents over 30 kg weight:_
The usual dose is 300 micrograms for intramuscular use.
_Children between 15 kg and 30 kg in weight*:_
The usual dose is 150 micrograms for intramuscular use.
*For these patients EpiPen Jr. Auto-Injector containing 150 micrograms
adrenaline per dose is
available
_Children below 15 kg in weight:_
The suitability of EpiPen Jr. has to be judged individually. The use
in children weighing less
than 7.5 kg is not recommended unless in a life-threatening situation
and under medical
advice.
_Adults_
The usual dose is 300 micrograms for intramuscular use.
An initial dose should be administered a