Adrenaline Aguettant

Adrenaline Aguettant

epinephrine

Manufacturer:

Laboratoire Aguettant

Distributor:

HK Medical Supplies

Marketer:

Aguettant
Full Prescribing Info
Contents
Adrenaline.
Description
Each ml of solution for injection contains 0.1 mg of adrenaline (as adrenaline tartrate).
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline tartrate).
Excipients/Inactive Ingredients: The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.
Action
Adrenaline Injection belongs to a group of medicines called adrenergic and dopaminergic agents.
Indications/Uses
This medicine is used for: Treatment of cardiac arrest (unexpected loss of heart function, breathing and consciousness).
Treatment of acute anaphylaxis in adults (serious shock or collapse produced by a severe allergic reaction).
Dosage/Direction for Use
The following information is intended for healthcare professionals only: Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice.
Cardiopulmonary resuscitation: 10 ml of the 1:10,000 solution (1 mg) by the intravenous or intraosseous route, repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use should only be considered as a last resort if no other route of administration is accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to 2.5 mg).
In cardiac arrest following cardiac surgery, Adrenaline should be administered intravenously in doses of 0.5 ml or 1 ml of 1:10,000 solution (50 or 100 micrograms) very cautiously and titrated to effect.
Acute anaphylaxis: Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05 mg) according to response.
Adrenaline 1 mg/10 ml (1:10,000) solution for injection in pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For intramuscular administration, a 1 mg/ml (1:1000) solution should be used.
Paediatric Population: This medicinal product is not appropriate to deliver a dose of less than 0.5 ml and should therefore not be used by the intravenous or intraosseous route, in neonates and infants with body weight less than 5 kg.
Cardiac arrest in children: Intravenous or intraosseous route (above 5 kg only): 0.1 ml/kg of 1:10,000 solution (10 micrograms/kg) to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use (any body weight) should only be considered as a last resort if no other route of administration is accessible, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg) to a maximum of single dose of 25 ml of 1:10,000 solution (2.5 mg).
Contraindications
The patient must not be given Adrenaline injection: If allergic (hypersensitive) to any ingredients of this medicine (listed in Description) where an alternative presentation of Adrenaline or alternative vasopressor is available.
Special Precautions
Adrenaline injection is indicated for emergency treatment. Continuous medical supervision is necessary after administration.
The risk of side effects is increased if the patient: has medical history of hyperthyroidism (disease of the thyroid gland); has severe renal insufficiency; suffers from hypercalcaemia (increase of calcium concentration in the blood); suffers from hypokalaemia (decrease of potassium concentration in the blood); has diabetes mellitus; has cardiac disease or arterial hypertension; has brain damage or hardening of the arteries in the brain; has glaucoma (increased pressure in the eye); has prostate disorders; is elderly; is pregnant.
Adrenaline injection contains sodium: This medicinal product contains 3.54 mg of sodium per ml of solution for injection. This needs to be taken into consideration by patients on strict sodium diet.
Driving and using machines: Having Adrenaline injection does not affect the ability to drive or use machines.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor, pharmacist or nurse for advice before this medicine is given.
Side Effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported: anxiety; dyspnoea (difficulty in breathing); nervousness; fear; sweating; palpitations (irregular or faster heart beat); tachycardia (increased heart rate); pallor; tremors; weakness; dizziness; headache; nausea; vomiting; coldness of the extremities; hallucinations; syncopes; hyperglycaemia (high blood sugar levels); hypokalaemia (low potassium levels in the blood); metabolic acidosis (increased acidity in the blood); mydriasis (dilatation of the pupil).
In high dosages or for patients sensitive to adrenaline, side effects are: cardiac dysrhythmia (irregular heartbeats/cardiac arrest); hypertension (with risk of cerebral haemorrhage); vasoconstriction (narrowing of the blood vessels for example cutaneous, in the extremities or kidneys); acute angina attacks; risk of acute myocardial infarction.
Repeated local injections may produce necrosis (tissue damage) at the site of injection as a result of vascular constriction (blood vessel constriction).
In all cases, after administration of Adrenaline injection medical supervision is necessary.
Reporting of side effects: If any side effects are experienced, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.
Drug Interactions
Tell the doctor if taking, have recently taken or might take any other medicines.
Medicines that may interact with Adrenaline injection include: Volatile halogen anaesthetics (gas used during anaesthesia); Certain antidepressants; Drugs to treat high blood pressure, heart conditions; Drugs to treat diabetes.
Caution For Usage
Do not open the aluminium pouch until use.
After opening the pouch the product must be used immediately.
Strictly respect the following protocol: The pre-filled syringe is for single patient use only. Discard the syringe after use. Do not reuse.
The product should be inspected visually for particles and discolouration prior to administration. Only clear colourless solution free from particles or precipitates should be used.
The product should not be used if the pouch or the blister has been opened or if the tamper evident seal on the syringe (plastic film at the basis of the end cap) is broken.
1) Tear open the aluminium pouch by hand only using the indent(s).
Do not use sharp instruments to open the pouch.
2) Withdraw the pre-filled syringe from the sterile blister.
3) Push on the plunger to free the bung.
The sterilisation process may have caused adhesion of the bung to the body of the syringe.
4) Twist off the end cap to break the seals.
Do not touch the exposed luer connection in order to avoid contamination.
5) Check the syringe seal tip has been completely removed.
If not, replace the cap and twist again.
6) Expel the air by gently pushing the plunger.
7) Connect syringe to vascular access device or to needle.
Push the plunger to inject the required volume.
Any unused product or waste material should be disposed of in accordance with local requirements.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Do not store above 25°C.
Store in the aluminium pouch in order to protect from light and oxygen.
Do not freeze.
MIMS Class
ATC Classification
C01CA24 - epinephrine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of hypotension.
Presentation/Packing
Soln for inj (pre-filled syringe) 1 mg/10 mL (clear, colourless solution) x 10 mL x 10's.
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