Adrenaline (base) 1mg/10ml (1 in 10,000) dilute solution for injection ampoules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Herunterladen Gebrauchsinformation (PIL)
07-06-2018
Herunterladen Fachinformation (SPC)
07-06-2018

Wirkstoff:

Adrenaline acid tartrate

Verfügbar ab:

base) 1mg/10ml (1 in 10,000) dilute solution for injection ampoules (Martindale Pharmaceuticals Ltd

ATC-Code:

C01CA24

INN (Internationale Bezeichnung):

Adrenaline acid tartrate

Dosierung:

100microgram/1ml

Darreichungsform:

Solution for injection

Verabreichungsweg:

Intraosseous; Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02070300; GTIN: 5014124170827 5026468000548

Gebrauchsinformation

                                This medicine will be referred to as Adrenaline Injection in the
rest of this leaflet
WHAT IS IN THIS LEAFLET
1. What Adrenaline Injection is and what it is used for.
2. What you need to know before you use Adrenaline Injection.
3. How Adrenaline Injection is given.
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 (Epinephrine) belongs to a group of medicines
used for the treatment of serious shock produced by a severe
allergic reaction or collapse. It may also be used to restart your
heart if it has stopped.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
ADRENALINE INJECTION
YOU SHOULD NOT BE GIVEN ADRENALINE INJECTION IF YOU ARE:
• allergic to adrenaline or any of the other ingredients of this
medicine listed in section 6
• have severe heart disease particularly if it is associated with
an increased heart rate
• are suffering from any infection, disease or tumour of
the brain
• have atherosclerosis which is a narrowing, and hardening
of the body’s blood vessels (your doctor will advise you).
• are in shock (other than that caused by a sudden life
threatening reaction).
• are suffering from glaucoma (increased pressure in the eye).
• are having or are about to have an operation under general
anaesthetic.
• are in labour
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before being given
Adrenaline Injection if:
• you are elderly
• you suffer from any heart problem, particularly if it affects
the heart rate or if you suffer from chest pain
• you have problems with your brain e.g. stroke, brain damage
or blood vessel disease
• you have an overactive thyroid, diabetes or glaucoma
(high pressure in the eye)
• you have phaeochromocytoma (a tumour on the
adrenal gland)
• you have low blood levels of potassium or high blood
levels of calcium
• you have a tumour on your prostate gland or kidney disease
• you are in shock or have lost a lot of blood
• you 
                                
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Fachinformation

                                OBJECT 1
DILUTE ADRENALINE (EPINEPHRINE) INJECTION
1:10,000 (AMPOULES)
Summary of Product Characteristics Updated 16-Jan-2018 | Martindale
Pharma
1. Name of the medicinal product
Dilute Adrenaline (Epinephrine) 1:10,000 Injection
2. Qualitative and quantitative composition
Each ml of the solution for injections contains 100 micrograms of
Adrenaline (Epinephrine) as the Acid
Tartrate.
Excipient with known effect
Each ml of Adrenaline 1:10,000 Injection contains 1mg of sodium
metabisulfite (E223) and 2.695 mg or
0.117 mmol of sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Clear, colourless and practically free from particles
4. Clinical particulars
4.1 Therapeutic indications
Cardiopulmonary Resuscitation
Acute Anaphylaxis when intramuscular route has been ineffective.
4.2 Posology and method of administration
Posology
Cardiopulmonary Resuscitation
Adults and children over 12 years
1 in 10,000 (1mg in 10ml) is recommended in a dose of 10ml (1mg), by
CENTRAL INTRAVENOUS INJECTION.
The procedure for Cardiopulmonary Resuscitation is given in the
algorithm which reflects the
recommendations of the European Resuscitation Council and the
Resuscitation Council (UK).
If venous access is not available, intraosseous (IO) route is
recommended.
The dose may be repeated at 3 minute intervals.
Paediatric population under 12 years
It is not recommended.
Elderly
It should be used with great caution in these patients who may be more
susceptible to the cardiovascular
side effects of adrenaline.
Acute life threatening allergic reactions/Acute Anaphylaxis
For specialist use only (see section 4.4)
Adults
Administer IV Adrenaline as a bolus. Titrate IV Adrenaline using 50
microgram boluses according to
response.
A dose of 50 micrograms is equivalent to 0.5ml.
If repeated adrenaline doses are needed, start an IV adrenaline
infusion with reference to local guidelines
on the preparation and infusion of adrenaline.
Paediatric population
Administer IV Adrenaline as a bolus. There is no 
                                
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