EpiPen Jr. 150micrograms/0.3ml (1 in 2,000) solution for injection auto-injectors

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Adrenaline

Dostupno od:

1 in 2,000) solution for injection auto-injectors (Viatris UK Healthcare Ltd

ATC koda:

C01CA24

INN (International ime):

Adrenaline

Doziranje:

500microgram/1ml

Farmaceutski oblik:

Solution for injection

Administracija rute:

Intramuscular

Razred:

No Controlled Drug Status

Tip recepta:

Caution - AMP level prescribing advised

Proizvod sažetak:

BNF: 03040300; GTIN: 5060141690039 5060141690053

Uputa o lijeku

NOT KNOWN (frequency cannot be estimated from
the available data):
Usual side effects include: irregular heartbeat
(including palpitations and rapid heartbeats),
high blood pressure, sweating, nausea, vomiting,
difficulty breathing, paleness, headache,
hypertension, dizziness, weakness, tremor and
apprehension, nervousness or anxiety.
RARE (may affect up to 1 in 1,000 people)
Cardiomyopathy has been seen in patients
treated with adrenaline.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE EPIPEN
® JR.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label and carton. The
expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or
freeze.
Keep container in the outer carton in order to
protect from light. When exposed to air or light,
adrenaline deteriorates rapidly and will become
pink or brown. PLEASE REMEMBER TO CHECK THE
CONTENTS OF THE GLASS CARTRIDGE IN THE EPIPEN
®
JR. AUTO-INJECTOR FROM TIME TO TIME TO MAKE
SURE THE LIQUID IS STILL CLEAR AND COLOURLESS.
DO NOT USE THIS MEDICINE IF YOU NOTICE THAT THE
LIQUID IS UNCLEAR, COLOURED OR CONTAINS SOLID
PARTICLES. REPLACE THE AUTO-INJECTOR BY THE
EXPIRY DATE OR EARLIER IF THE SOLUTION IS
DISCOLOURED OR CONTAINS A PRECIPITATE
(SOLID PARTICLES).
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
See also section 3 – Directions for use.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT EPIPEN
® JR. CONTAINS
The active substance is adrenaline 0.15 mg
(150 microgram).
The other ingredients are: Sodi

Svojstava lijeka

OBJECT 1
EPIPEN JR ADRENALINE (EPINEPHRINE) AUTO-
INJECTOR 0.15MG
Summary of Product Characteristics Updated 29-May-2018 | Mylan
Products Limited
1. Name of the medicinal product
EpiPen® Jr. Adrenaline (Epinephrine) Auto Injector 0.15 mg
2. Qualitative and quantitative composition
Per 1 ml:
ACTIVE INGREDIENT
QUANTITY / UNIT
REFERENCE STANDARDS
Adrenaline (Epinephrine)
0.5 mg
BP/USP
Excipients with known effect: 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 an auto-injector (prefilled, disposable
automatic injection device) for
intramuscular use.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
EpiPen® Jr.auto injectors are automatic injection devices containing
adrenaline for allergic emergencies.
The auto injector is intended for children at a body weight of 7.5-25
kg. The auto injectors should be used
only by a person with a history or an acknowledged risk of an
anaphylactic reaction. The auto injectors
are indicated in the emergency treatment of allergic reactions
(anaphylaxis) to insect stings or bites,
foods, drugs and other allergens as well as idiopathic or exercise
induced anaphylaxis. Such 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, diarrhoea
and abdominal cramps, involuntary voiding, wheezing, dyspnoea due to
laryngeal spasm, pruritus, rashes,
urticaria or angioedema.
For these reasons auto injectors should always be carried by such
persons in situations of potential risks.
Adrenaline is considered the first line drug of choice for allergic
emergencies. Adrenaline effectively
reverses the symptoms of rhinitis, urticaria, bronchospasm and
hypotension because it is a
pharmacological antagonist to the effects of the chemical mediators on
smooth muscles, blood vessels and
other tissues. Adrenali