EMERADE Solution for injection in a pre-filled pen (2020)
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Περιεχόμενα
1. Name of the medicinal product
Emerade 150 micrograms solution for injection in pre-filled pen. Emerade 300 micrograms solution for injection in pre-filled pen. Emerade 500 micrograms solution for injection in pre-filled pen.
2. Qualitative and quantitative composition
The pre-filled pen contains 0.5 ml of adrenaline solution 1 mg/ml. Emerade 150 micrograms delivers a single dose of 0.15 ml containing 150 micrograms of adrenaline (as tartrate). Emerade 300 micrograms ...
3. Pharmaceutical form
Solution for injection in a pre-filled pen (auto-injector). Clear and colourless solution.
4.1. Therapeutic indications
Emerade is indicated for the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens as well as for ...
4.2. Posology and method of administration
Posology The effective dose is usually within the range 5-10 micrograms per kg bodyweight but higher doses may be necessary in some cases. Paediatric population Use in children: Emerade 500 micrograms ...
4.3. Contraindications
There are no absolute contraindications to the use of Emerade in an allergic emergency.
4.4. Special warnings and precautions for use
Do not remove the needle shield until ready for use. Emerade must be administrated only into the anterolateral thigh. The injection is delivered immediately after the triggering cylinder is pressed against ...
4.5. Interaction with other medicinal products and other forms of interaction
Certain medicines can enhance the effect of adrenaline: Tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, and catechol-O-methyl transferase (COMT) inhibitors. Adrenaline must be used with ...
4.6. Pregnancy and lactation
There are no adequate or well-controlled studies of adrenaline during pregnancy. Adrenaline should be used in pregnancy only when the potential benefit to the mother outweighs the possible risk to the ...
4.7. Effects on ability to drive and use machines
Emerade has no or negligible influence on the ability to drive and use machines, however, patients are not recommended to drive or use machines following administration of adrenaline, since they will be ...
4.8. Undesirable effects
Side-effects of adrenaline in general are associated with the α- and β-receptor activity of adrenaline. The following table is based upon experience with the use of adrenaline. The adverse events were ...
4.9. Overdose
An overdose, or an accidental intravascular injection of adrenaline, can originate a sudden increase in blood pressure that can cause cerebral haemorrhage. Severe pulmonary oedema caused by peripheral ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Cardiac stimulants excl. cardiac glycosides Adrenergic and dopaminergic agents – Adrenaline <b>ATC-code:</b> C01CA24 Adrenaline is the natural active sympathomimetic ...
5.2. Pharmacokinetic properties
Circulating adrenaline is metabolized in the liver and other tissues by the enzymes COMT and MAO. Inactive metabolites are excreted in the urine. The half-life of adrenaline in plasma is about 2 to 3 minutes. ...
5.3. Preclinical safety data
Adrenaline has been extensively used in the emergency treatment of severe allergic reactions for many years. There is no further preclinical data relevant for prescribers besides those already described ...
6.1. List of excipients
Sodium chloride Sodium meta-bisulfite (E223) Disodium edetate Hydrochloric acid (for adjustment of pH) Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
18 months.
6.4. Special precautions for storage
Store in the original outer carton, however while carrying by patient/carer it is acceptable to store in the specially designed case provided. The pen must always be kept in this case to ensure it is protected. ...
6.5. Nature and contents of container
Emerade consists of a pre-filled syringe made of glass with a polyisoprene rubber needle plunger in an auto-injector. Emerade is latex free. Exposed needle length Emerade 150 micrograms: 16 mm Emerade ...
6.6. Special precautions for disposal and other handling
It is very important that the patient receives detailed information on how to use Emerade. For single use only. The expiry date is indicated on the label and on the outer carton and Emerade should not ...
7. Marketing authorization holder
PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic
8. Marketing authorization number(s)
Emerade 150 micrograms: PL 33616/0013 Emerade 300 micrograms: PL 33616/0014 Emerade 500 micrograms: PL 33616/0015
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 03 January 2013
10. Date of revision of the text
20 Jan 2020
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