DEXDOR Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Dexdor 100 micrograms/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine. Each 2 ml ampoule contains 200 micrograms of dexmedetomidine. Each 2 ml vial contains 200 micrograms ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution, pH 4.5–7.0.
Therapeutic indications
For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) ...
Posology and method of administration
For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Advanced heart block (grade 2 or 3) unless paced. Uncontrolled hypotension. Acute cerebrovascular conditions. ...
Special warnings and precautions for use
Monitoring Dexdor is intended for use in an intensive care setting, operating room and during diagnostic procedures. The use in other environments is not recommended. All patients should have continuous ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Co-administration of dexmedetomidine with anaesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects, including ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of dexmedetomidine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Dexdor should not be used during ...
Effects on ability to drive and use machines
Patients should be advised to refrain from driving or other hazardous tasks for a suitable period of time after receiving Dexdor for procedural sedation.
Undesirable effects
Summary of the safety profile Sedation of adult ICU (Intensive Care Unit) patients The most frequently reported adverse reactions with dexmedetomidine in ICU setting are hypotension, hypertension and bradycardia, ...
Overdose
Symptoms Several cases of dexmedetomidine overdose have been reported both in the clinical trial and the post-marketing data. The reported highest infusion rates of dexmedetomidine in these cases have ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, other hypnotics and sedatives ATC code: N05CM18 Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties. It has ...
Pharmacokinetic properties
The pharmacokinetics of dexmedetomidine has been assessed following short term IV administration in healthy volunteers and long term infusion in ICU population. Distribution Dexmedetomidine exhibits a ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity. In the reproductive toxicity studies, dexmedetomidine ...
List of excipients
Sodium chloride Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Compatibility studies have shown potential for adsorption of dexmedetomidine to some types ...
Shelf life
3 years. After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the ampoules or vials in the outer carton in order to protect from light. For storage conditions after dilution ...
Nature and contents of container
2 ml Type I glass ampoules. 2, 5 or 10 ml Type I glass vials (with filling volumes of 2, 4 and 10 ml), grey bromobutyl rubber closure with fluoropolymer coating. Pack sizes: 5 2 ml ampoules 25 2 ml ampoules ...
Special precautions for disposal and other handling
Ampoules and vials are intended for single patient use only. Preparation of solution Dexdor can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol or sodium chloride 9 mg/ml (0.9%) solution for injection ...
Marketing authorization holder
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Marketing authorization number(s)
EU/1/11/718/001-002 EU/1/11/718/004 EU/1/11/718/006-007
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 September 2011 Date of latest renewal: 26 May 2016
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