Indications

Adrenaline (Epinephrine) 1 mg/ml (1:1000) Solution for Injection may be used in the emergency treatment of

• anaphylaxis

• acute allergic reactions

Dosage and Administration

Usage:I.M.

1.Adults: The usual dose is 0.5 mg (0.5ml of adrenaline 1mg/ml (1:1000)). If necessary, this dose may be repeated several times at 5-minute intervals according to blood pressure, pulse and respiratory function.

2.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.

Precautions & Warning:

1.This product is for emergency use only and medical supervision of the patients is necessary after administration.

2.Adrenaline (Epinephrine) 1 mg/ml (1:1000) Solution for Injection 1mg/ml (1:1000) is not suitable for IV use.

The IM route is generally preferred in the initial treatment of anaphylaxis, the IV route is generally more appropriate in the Intensive Care Unit or Emergency Department setting. Adrenaline (Epinephrine) 1mg/ml (1:1000) solution for injection is not suitable for IV use. If the adrenaline 0.1 mg/ml (1:10000) injection is not available, Adrenaline 1mg/ml (1:1000) solution must be diluted to 0.1 mg/mL (1:10000) before IV use. The IV route for injection of adrenaline must be used with extreme caution and is best reserved for specialists familiar with IV use of adrenaline.

3.Adrenaline should be used with caution in patients with hyperthyroidism, diabetes mellitus, narrow angle glaucoma, phaeochromocytoma, hypertension, hypokalaemia, hypercalcaemia, severe renal impairment, prostatic adenoma leading to residual urine, cerebrovascular disease, elderly patients, patients with shock (other than anaphylactic shock), organic heart disease or cardiac dilatation, (severe angina pectoris, obstructive cardiomyopathy, hypertension), as well as most patients with arrhythmias, organic brain damage or cerebral arteriosclerosis. Anginal pain may be induced when coronary insufficiency is present.

4.Adrenaline should be used with caution during the second stage of labour (See Pregnancy and Lactation).

5.Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients.

Contraindications:

1.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

2.Contraindications are relative as this product is intended for use in life-threatening emergencies.

• Use in fingers, toes, ears, nose genitalia or buttocks owing to the risk of ischaemic tissue necrosis.

• Do not use if solution is discoloured.

Adverse Reactions:

The adverse events of adrenaline mainly relate to the stimulation of both alpha- and beta-adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved.

1.Metabolism and nutrition disorders:

Frequency not known: hyperglycaemia, hypokalaemia, metabolic acidosis.

2.Psychiatric disorders:

Frequency not known: anxiety, nervousness, fear, hallucinations.

3.Nervous system disorders:

Frequency not known: headache, tremors, dizziness, syncope.

In patients with Parkinsonian Syndrome, Adrenaline increases rigidity and tremor.

4.Eye disorders: Frequency not known: mydriasis.

5.Cardiac disorders:

Frequency not known: palpitations, tachycardia. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction.

6.Vascular disorders:

Frequency not known: pallor, coldness of the extremities. In high dosage or for patients sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction (for example cutaneous, in the extremities or kidneys)

Respiratory, thoracic and mediastinal disorders:

Frequency not known: dyspnoea.

7.Gastrointestinal disorders:Frequency not known: nausea, vomiting.

8.General disorders and administration site conditions:

Frequency not known: sweating, weakness

Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction.

Drug interactions:

1.Sympathomimetic agents/Oxytocin: Adrenaline should not be administered concomitantly with oxytocin or other sympathomimetic agents because of the possibility of additive effects and increased toxicity.

2.Alpha-adrenergic blocking agents

3.Beta-adrenergic blocking agents

4.General anaesthetics

5.Antidepressant agents

Storage instructions:

Keep ampoules in original carton in order to protect from light.

Do not freeze

Do not store above 25ºC