Jext 150 micrograms solution for injection in pre-filled pen

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Adrenaline

Tillgänglig från:

ALK-Abello A/S

ATC-kod:

C01CA; C01CA24

INN (International namn):

Adrenaline

Dos:

150 microgram(s)

Läkemedelsform:

Solution for injection in pre-filled pen

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Adrenergic and dopaminergic agents; epinephrine

Bemyndigande status:

Marketed

Tillstånd datum:

2011-02-18

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JEXT 150 MICROGRAMS, SOLUTION FOR INJECTION IN PRE-FILLED PEN
JEXT 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Jext is and what it is used for
2.
What you need to know before you use Jext
3.
How to use Jext
4.
Possible side effects
5.
How to store Jext
6.
Contents of the pack and other information
1.
WHAT JEXT IS AND WHAT IT IS USED FOR
Jext contains a sterile solution of adrenaline within an auto-injector
for emergency injection of a
single dose of adrenaline into the outer part of the thigh muscle
(intramuscular injection).
Jext is to be used for the emergency treatment of sudden
life-threatening allergic reactions
(anaphylactic shock) to insect stings or bites, foods or drugs or
exercise.
Symptoms that signal the onset of an anaphylactic shock occur within
minutes of exposure to the
allergen and include: itching of the skin; raised rash (like a nettle
rash); flushing; swelling of the
lips, throat, tongue, hands and feet; wheezing; hoarseness; shortness
of breath; nausea; vomiting;
stomach cramps and in some cases, loss of consciousness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JEXT
Jext can always be used during an allergic emergency. If you are
allergic (hypersensitive) to sodium
metabisulphite or to any of the other ingredients of Jext, your doctor
will need to instruct you under
which circumstances Jext should be used. For further information on
hypersensitivity to sulphites

Produktens egenskaper

Health Products Regulatory Authority
01 November 2023
CRN00DCJV
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Jext 150 micrograms solution for injection in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Jext 150 micrograms: One pre-filled pen delivers one dose of 0.15ml
solution for injection containing 150 micrograms of
adrenaline (as tartrate).
1 ml solution contains 1mg adrenaline (as tartrate).
Excipients with known effect: Sodium metabisulphite (E223) 0.086
mg/dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
Clear and colourless solution, free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Jext is indicated in the emergency treatment of severe acute 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_
Patients between 15 kg and 30 kg in weight:
The usual dose is 150 micrograms.
A dosage below 150 micrograms cannot be administered in sufficient
accuracy in children weighing less than 15 kg and use is
therefore not recommended unless life-threatening situation and under
medical advice. Children and adolescents over 30 kg in
weight should be prescribed a Jext 300 micrograms.
An initial dose should be administered as soon as symptoms of
anaphylaxis are recognised.
The effective dose is typically in the range of 0.005-0.01 mg/kg but
higher doses may be necessary in some cases.
In the absence of clinical improvement or if deterioration occurs, a
second injection with an additional Jext may be
administered 5–15 minutes after the first injection. It is
recommended that patients are prescribed two Jext pens which they
should carry at all times.
Method of administration
For intramuscular use.
For single use.
Jext is for intramuscular administration into the anterolateral thigh.
It is designed to inject throug