ADRENALINE AGUETTANT Solution for injection in pre-filled syringe (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe.
Qualitative and quantitative composition
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). Excipient with known effect: sodium. ...
Pharmaceutical form
Solution for injection in pre-filled syringe. Clear and colourless solution in a 10 ml pre-filled syringe. pH = 3.0 to 3.4 Osmolarity: 270–300 mOsm/l
Therapeutic indications
Cardiopulmonary resuscitation. Acute anaphylaxis in adults.
Posology and method of administration
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 ...
Contraindications
Patients with known hypersensitivity to an excipient, where an alternative presentation of adrenaline or alternative vasopressor is available.
Special warnings and precautions for use
Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe is indicated for emergency treatment. Medical supervision is necessary after administration. For intramuscular administration, ...
Interaction with other medicinal products and other forms of interaction
<em>Volatile halogen anaesthetics:</em> severe ventricular arrhythmia (increase in cardiac excitability). <em>Imipramine antidepressants:</em> paroxysmal hypertension with the possibility of arrhythmia ...
Fertility, pregnancy and lactation
Pregnancy Teratogenic effect has been demonstrated in animal experiments. Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during ...
Effects on ability to drive and use machines
Not applicable in normal conditions of use.
Undesirable effects
Metabolism and nutrition disorders Frequency not known: hyperglycaemia, hypokalaemia, metabolic acidosis. Psychiatric disorders Frequency not known: anxiety, nervousness, fear, hallucinations. Nervous ...
Overdose
Over dosage or inadvertent intravenous administration of adrenaline may produce severe hypertension. Cerebral, cardiac or vascular accidents which could be potentially fatal may occur as a result (cerebral ...
Pharmacodynamic properties
Pharmacotherapeutic group: adrenergic and dopaminergic agents, adrenaline ATC code: C01CA24 Adrenaline is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has ...
Pharmacokinetic properties
Pharmacologically active concentrations of adrenaline are not achieved following oral administration as it is rapidly oxidised and conjugated in the gastrointestinal mucosa and the liver. Absorption from ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
List of excipients
Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other medicinal products.
Shelf life
Unopened: 24 months.
Special precautions for storage
Do not store above 25°C. Do not freeze. Store in the aluminium pouch in order to protect from light and oxygen.
Nature and contents of container
10 ml solution in a polypropylene pre-filled syringe without a needle, individually packaged in a transparent blister and overwrapped in an aluminium pouch containing an oxygen absorbing sachet. Available ...
Special precautions for disposal and other handling
The aluminium pouch and syringe blister should only be opened immediately prior administration. After opening the pouch the product must be used immediately. The external surface of the syringe and its ...
Marketing authorization holder
Laboratoire Aguettant, 1 rue Alexander Fleming, 69007 LYON, FRANCE
Marketing authorization number(s)
PL 14434/0031
Date of first authorization / renewal of the authorization
10/12/2015
Date of revision of the text
11/03/2019
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