BETALOC Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Betaloc I.V. Injection.
Qualitative and quantitative composition
Each ampoule of 5 ml contains 5 mg Metoprolol tartrate Ph. Eur. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for Injection.
Therapeutic indications
Control of tachyarrhythmias, especially supraventricular tachyarrhythmias. Early intervention with Betaloc I.V. Injection in acute myocardial infarction reduces infarct size and the incidence of ventricular ...
Posology and method of administration
Posology The dose must always be adjusted to the individual requirements of the patient. The following are guidelines: Cardiac arrhythmias Initially up to 5 mg injected intravenously at a rate of 1-2 mg ...
Contraindications
Betaloc I.V. Injection, as with other beta blockers, should not be used in patients with any of the following: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. ...
Special warnings and precautions for use
When treating patients with suspected or definite myocardial infarction the haemodynamic status of the patient should be carefully monitored after each of the three 5 mg intravenous doses. The second or ...
Interaction with other medicinal products and other forms of interaction
Metoprolol is a metabolic substrate for the Cytochrome P450 isoenzyme CYP2D6. Drugs that act as enzyme-inducing and enzyme-inhibiting substances may exert an influence on the plasma level of metoprolol. ...
Pregnancy and lactation
Pregnancy Betaloc I.V. Injection should not be used in pregnancy or nursing mothers unless the physician considers that the benefit outweighs the possible hazard to the foetus/infant. In general, beta-blockers ...
Effects on ability to drive and use machines
Betaloc I.V. Injection has minor influence on the ability to drive and use machines. It should be taken into account that occasionally dizziness or fatigue may occur.
Undesirable effects
The following events have been reported as adverse events in clinical trials or reported from routine use. The following definitions of frequencies are used: Very common (≥1/10), common (≥1/100 to <1/10), ...
Overdose
Symptoms Symptoms of overdose may include hypotension, cardiac insufficiency, bradycardia and bradyarrhythmia, cardiac conduction disturbances and bronchospasm. Management Care should be provided at a ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents, selective ATC code: C07AB02 Mechanism of action Metoprolol is a competitive beta-adrenoceptor antagonist. It acts preferentially to inhibit beta-adrenoceptors ...
Pharmacokinetic properties
Biotransformation Metoprolol undergoes oxidative metabolism in the liver primarily by the CYP2D6 isoenzyme. Elimination Metoprolol is eliminated mainly by hepatic metabolism, the average elimination half-life ...
Preclinical safety data
Pre-clinical information has not been included because the safety profile of metoprolol tartrate has been established after many years of clinical use. Please refer to section 4.
List of excipients
Sodium chloride Water for injections
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Protect from light. Store below 25°C.
Nature and contents of container
5 ml glass ampoule.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland
Marketing authorization number(s)
PL 30883/0007
Date of first authorization / renewal of the authorization
Date of first authorisation: 28<sup>th</sup> May 2002 Date of renewal of authorisation: 16<sup>th</sup> July 2005
Date of revision of the text
July 2018
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