BUCCOLAM Oromucosal solution (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
BUCCOLAM 2.5 mg oromucosal solution. BUCCOLAM 5 mg oromucosal solution. BUCCOLAM 7.5 mg oromucosal solution. BUCCOLAM 10 mg oromucosal solution.
Qualitative and quantitative composition
<u>BUCCOLAM 2.5 mg oromucosal solution:</u> Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution. <u>BUCCOLAM 5 mg oromucosal solution:</u> Each pre-filled oral ...
Pharmaceutical form
Oromucosal solution. Clear colourless solution. pH 2.9 to 3.7
Therapeutic indications
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years). BUCCOLAM must only be used by parents/carers where the patient has been ...
Posology and method of administration
Posology Standard doses are indicated below: Age range Dose Label colour 3 to 6 months hospital setting 2.5 mg Yellow > 6 months to < 1 year 2.5 mg Yellow 1 year to < 5 years 5 mg Blue 5 years to < ...
Contraindications
Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1. Myasthenia gravis. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic impairment. ...
Special warnings and precautions for use
Respiratory insufficiency Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Paediatric patients aged 3 to 6 months ...
Interaction with other medicinal products and other forms of interaction
Midazolam is metabolized by CYP3A4. Inhibitors and inducers of CYP3A4 have the potential to respectively increase and decrease the plasma concentrations and, subsequently, the effects of midazolam thus ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of midazolam in pregnant women. Animal studies do not indicate a teratogenic effect with respect to reproductive toxicity, but foetotoxicity ...
Effects on ability to drive and use machines
Midazolam has a major influence on the ability to drive and use machines. Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive, ride a bicycle ...
Undesirable effects
Summary of the safety profile Published clinical studies show that oromucosal midazolam was administered to approx 443 children with seizures. Respiratory depression occurs at a rate of up to 5%, although ...
Overdose
Symptoms Midazolam overdose can present a threat to life if the patient has pre-existing respiratory or cardiac insufficiency, or when combined with other CNS depressants (including alcohol). Overdose ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, benzodiazepine derivatives ATC code: N05CD08 Mechanism of action Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance ...
Pharmacokinetic properties
Simulated pharmacokinetic parameters for the recommended posology in children aged 3 months to less than 18 years, based on a population pharmacokinetic study are provided in tabulated format below: Dose ...
Preclinical safety data
In a rat fertility study, animals dosed up to ten times the clinical dose, no adverse effects on fertility were observed. There are no other preclinical data of relevance to the prescriber which are additional ...
List of excipients
Sodium chloride Water for injections Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt) Sodium hydroxide (for pH adjustment)
Incompatibilities
Not applicable.
Shelf life
18 months.
Special precautions for storage
Keep the oral syringe in the protective plastic tube. Do not refrigerate or freeze.
Nature and contents of container
Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube. Strength Volume of solution ...
Special precautions for disposal and other handling
Administration of BUCCOLAM BUCCOLAM is not for intravenous use. Step 1: Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube. Step 2: Pull the red cap ...
Marketing authorization holder
Shire Services BVBA, rue Montoyer 47, 1000 Brussels, Belgium
Marketing authorization number(s)
BUCCOLAM 2.5 mg oromucosal solution: EU/1/11/709/001 BUCCOLAM 5 mg oromucosal solution: EU/1/11/709/002 BUCCOLAM 7.5 mg oromucosal solution: EU/1/11/709/003 BUCCOLAM 10 mg oromucosal solution: EU/1/11/709/004 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 05 September 2011 Date of latest renewal: 26 May 2016
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