RAPIBLOC Powder for solution for infusion
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Rapibloc 300 mg powder for solution for infusion. Rapibloc 600 mg powder for solution for infusion.
Qualitative and quantitative composition
A vial contains 300 mg or 600 mg landiolol hydrochloride which is equivalent to 280 mg or 560 mg landiolol. After reconstitution (see section 6.6), each ml contains 6 mg or 12 mg landiolol hydrochloride. ...
Pharmaceutical form
Powder for solution for infusion. White to almost white powder.
Therapeutic indications
Supraventricular tachycardia and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term ...
Posology and method of administration
Posology Landiolol is intended for intravenous use in a monitored setting. Only a well-qualified health care professional should administer landiolol. The dosage of landiololshould be titrated individually. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe bradycardia (less than 50 beats per minute) Sick sinus syndrome Severe atrioventricular (AV) nodal conductance ...
Special warnings and precautions for use
Rapibloc must be reconstituted before administration and used immediately after opening (see section 6). Landiolol should be used with caution in diabetics or in case of hypoglycaemia. Hypoglycaemia is ...
Interaction with other medicinal products and other forms of interaction
Calcium antagonists such as dihydropyridine derivatives (e.g. nifedipine) may increase the risk of hypotension. In patients with cardiac insufficiency, concomitant treatment with beta-blocking agents may ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Rapibloc in pregnant women available. Animal studies do not indicate clinically relevant effects with respect to reproductive toxicity (see section 5.3). As ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
a. Summary of the safety profile The most frequently observed adverse drug reaction (ADR) reported for clinical trials (1,569 patients) and for postmarketing treatment outcome studies/use surveys (1,257 ...
Overdose
In case of overdose the following symptoms can occur: Severe hypotension, severe bradycardia, AV block, heart insufficiency, cardiogenic shock, cardiac arrest, bronchospasm, respiratory insufficiency, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-blocking agents, selective ATC code: C07AB14 Mechanism of action/Pharmacodynamic effects Landiolol is a highly selective beta-1-adrenoreceptor antagonist (the selectivity ...
Pharmacokinetic properties
When administered by continuous intravenous infusion, the concentration of landiolol in blood reached steadystate values about 15 minutes after initiation of administration. Steady-state can also be achieved ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, toxicity to reproduction and development. ...
List of excipients
Mannitol E421 Sodium hydroxide (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. Chemical and physical in-use stability after reconstitution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Colourless glass (Type 1) 50 ml vial with a bromobutyl rubber stopper and an aluminium flip-off seal. Pack size of 1 vial includes 300 mg (the colour code of the flip-off seal is yellow) or 600 mg (the ...
Special precautions for disposal and other handling
Rapibloc must not be administered without reconstitution. Instructions for use Reconstitute 1 vial with 50 ml of one of the following solutions: NaCl 9 mg/ml (0.9%) solution Glucose 50 mg/ml (5%) solution ...
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
