Adrenaline (base) for anaphylaxis 1mg/1ml (1 in 1,000) solution for injection pre-filled syringes

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Indlægsseddel Indlægsseddel (PIL)
19-06-2018
Produktets egenskaber Produktets egenskaber (SPC)
19-06-2018

Aktiv bestanddel:

Adrenaline

Tilgængelig fra:

base) for anaphylaxis 1mg/1ml (1 in 1,000) solution for injection pre-filled syringes (Martindale Pharmaceuticals Ltd

ATC-kode:

C01CA24

INN (International Name):

Adrenaline

Dosering:

1mg/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Subcutaneous; Intramuscular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 03040300; GTIN: 5026468000401

Indlægsseddel

                                In emergencies it may be necessary to administer an adrenaline
solution slowly into a vein (intravenous). Your doctor will decide
the correct dosage for you and when and how the injection should
be administered.
DOSAGE:
ADULTS: 500 micrograms (0.5 ml) of 1:1000 adrenaline solution
given by injection into the muscle (intramuscular)
CHILDREN: Volume of 1:1000 adrenaline to administer is shown in
brackets.
AGE
DOSE
Over 12 years
0.5 mg IM (0.5ml 1:1000
solution)
6 - 12 years
0.3 mg IM (0.3ml 1:1000
solution)
6 months - 6 years
0.15 mg IM (0.15ml 1:1000
solution)
Under 6 months
0.01mg/kg IM (0.01ml/kg
1:1000 solution)
Repeat the intramuscular dose if there is no improvement in the
patients condition. Further doses can be given at 5 minute intervals
according to the patient’s response.
IF YOU ARE GIVEN MORE ADRENALINE INJECTION THAN YOU SHOULD
As this medicine will be given to you whilst you are in hospital, it
is
unlikely that you will be given too little or too much, however, tell
your doctor or nurse if you have any concerns.
4.
POSSIBLE SIDE EFFECTS
Like all medicines Adrenaline Injection can cause side effects,
although not everybody gets them.
IF YOU EXPERIENCE ANY OF THESE FOLLOWING SIDE EFFECTS, STOP TAKING
THIS MEDICINE AND REPORT TO A DOCTOR IMMEDIATELY:
• allergic reactions although serious allergic reactions are rare
• any sudden wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting your
whole body).
Other side effects (Not known: frequency cannot be estimated from
the available data):
• headache
• dizziness
• feelings of anxiety or fear or restlessness
• trembling
• insomnia, confusion, irritability
• abnormal mood or behaviour
• a dry mouth or producing too much saliva
• weakness or sweating
• changes in the rhythm and speed of the heart
• high blood pressure
• coldness of the arms or legs
• breathlessness
• reduced appetite, feeling sick or being sick
• repeated injections may damage tissues at the site of the

                                
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Produktets egenskaber

                                OBJECT 1
ADRENALINE (EPINEPHRINE) INJECTION (1:1000) FOR
ANAPHYLAXIS (GLASS PREFILLED SYRINGE)
Summary of Product Characteristics Updated 20-Dec-2017 | Martindale
Pharma
1. Name of the medicinal product
Adrenaline (Epinephrine) (1:1000) Injection for Anaphylaxis
2. Qualitative and quantitative composition
Each ml contains 1mg Adrenaline (Epinephrine) as the Acid Tartrate
Excipient with known effect:
Sodium metabisulfite: 0.90 – 1.10 mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
Clear and colourless solution, practically free from particles
4. Clinical particulars
4.1 Therapeutic indications
To provide rapid relief for Anaphylaxis or Acute Allergy (Angioedema)
both to drugs and other allergens.
4.2 Posology and method of administration
The intramuscular (IM) route is recommended by the UK Resuscitation
Council as the most appropriate
for most individuals who have to give adrenaline to treat an
anaphylactic reaction.
The subcutaneous route for adrenaline is not recommended for treatment
of an anaphylactic reaction as it
is less effective.
Half doses of adrenaline may be safer for patients who are taking
amitriptyline, imipramine or a beta
blocker.
Dosage:
Adults:
500 micrograms (0.5ml) of 1:1000 adrenaline solution
Elderly:
There are no specific dosage regimes for adrenaline injection in
elderly patients. However, Adrenaline
should be used with great caution in these patients who may be more
susceptible to the cardiovascular
side effects of adrenaline.
Paediatric population:
The following doses of adrenaline 1/1,000 are recommended:
Age
Dose
Over 12 years
0.5 mg IM (0.5ml 1:1000 solution)
6 - 12 years
0.3 mg IM (0.3ml 1:1000 solution)
6 months - 6 years
0.15 mg IM (0.15ml 1:1000 solution)
Under 6 months
0.01mg/kg IM (0.01ml/kg 1:1000 solution)
Repeat the IM adrenaline dose if there is no improvement in the
patient's condition. Further doses can be
given at about 5-minute intervals according to the patient's response.
There is a much greater risk of causing h
                                
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