Adrenaline (Epinephrine) 1:1,000 Solution for Injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Adrenaline (epinephrine)

Հասանելի է:

Mercury Pharmaceuticals (Ireland) Ltd

ATC կոդը:

C01CA; C01CA24

INN (Միջազգային անվանումը):

Adrenaline (epinephrine)

Դոզան:

1 milligram(s)/millilitre

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

Product subject to prescription which may not be renewed (A)

Թերապեւտիկ տարածք:

Adrenergic and dopaminergic agents; epinephrine

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

1979-04-01

Տեղեկատվական թերթիկ

READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
ARE
GIVEN
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 nurse.
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution
for Injection. It will
be referred to as Adrenaline Injection for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Adrenaline Injection is and what it is used for
2. What you need to know before you are given Adrenaline Injection
3. How Adrenaline Injection will be given to you
4. Possible side effects
5. How to store Adrenaline Injection
6. Contents of the pack and other Information
1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Adrenaline belongs to a class of drugs called sympathomimetic agent.
Adrenaline Injection
may be used to rapidly relieve severe allergic reactions to drugs or
other substances
causing allergy. It may also be used in the emergency treatment of
shock due to a severe
allergic reaction.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE INJECTION
YOU SHOULD NOT BE GIVEN ADRENALINE INJECTION:
• if you are allergic to adrenaline, or to any of the other
ingredients of this medicine (listed
in section 6)
• when you are in labour
• if you are suffering from any infection, disease or tumour of the
brain
• if you have atherosclerosis which is a narrowing, and hardening of
the body’s blood
vessels (your doctor will advise you).
Adrenaline injection should not be used in areas such as fingers,
toes, ears, nose or penis,
as the blood supply to these areas might become inadequate.
Speak to your doctor if one of these applies to you before you are
given this medicine.
In an emergency, your doctor may still give you adrenaline even if you
suffer from any of
the above, as the potential benefit may be greater than the risk.
WARNINGS AND PRECAUTIO

Ապրանքի հատկությունները

Health Products Regulatory Authority
01 December 2021
CRN00CP17
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adrenaline (Epinephrine) 1:1,000 Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains Adrenaline (Epinephrine)
Acid Tartrate equivalent to 1mg Adrenaline (Epinephrine)
Excipients with known effect:
Sodium Metabisulphate (E223)
This medicinal product contains 3.389 mg/ml (0.147mmoles/ml) of
sodium, less than 1 mmol sodium (23 mg) per ml, i.e.
essentially ‘sodium- free’.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adrenaline Injection may be used to relieve bronchial spasm in acute
attacks of asthma. It may also be used to provide rapid
relief of hypersensitivity reactions to drugs and other allergens, and
in the emergency treatment of anaphylactic shock.
Adrenaline Injection may be used in follow-up treatment in
cardiopulmonary resuscitation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: The usual dose is 0.3 to 0.5mg (0.3 to 0.5ml). If necessary,
this may be repeated at 15 to 20 minute intervals for two
doses, then subsequently every four hours as required. A dose of 1mg
(1ml) can be given as a single injection in severe allergic
reactions and anaphylactic shock.
_PAEDIATRIC POPULATION_
The following doses of adrenaline 1/1,000 are recommended:
AGE
DOSE
Over 12 years
0.5mg IM (0.5ml 1:1000 solution)
6-12 years
0.3mg IM (0.3ml 1:1000 solution)
6 months – 6 years
0.15mg IM (0.15ml 1:1000 solution)
Under 6 months
0.01mg/kg IM (0.01ml/kg 1:1000 solution)
If necessary, these doses may be repeated at 5-15 minute intervals
according to blood pressure, pulse and respiratory function.
A small volume syringe should be used.
Elderly: The dosage is the same as for younger adults but particular
caution is required when administering adrenaline to
elderly patients (see section 4.4).
Renal impairment: