ATIVAN Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Ativan 4mg/ml Solution for injection.
Qualitative and quantitative composition
Lorazepam 4 mg/ml.
Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(o-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.
Excipient(s) with known effect:
Ativan Injection conta...
Pharmaceutical form
Solution for injection.
Clear, colourless solution supplied in clear glass ampoules.
Therapeutic indications
Pre-operative medication or premedication for uncomfortable or prolonged investigations, e.g. bronchoscopy, arteriography, endoscopy.
The treatment of acute anxiety states, acute excitement or acut...
Posology and method of administration
Posology
Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible.
Treatment in all patients should be withdrawn gradua...
Contraindications
Acute pulmonary insufficiency
Hypersensitivity to benzodiazepines, including lorazepam or to any of the excipients listed in section 6.1.
Sleep apnoea syndrome.
Myasthenia gravis.
Severe hepatic in...
Special warnings and precautions for use
Prior to use, Ativan Injection may be diluted for IM administration and should always be diluted for IV administration with equal amounts of compatible diluent (see section 4.2). Intravenous inject...
Interaction with other medicinal products and other forms of interaction
Not recommended: Concomitant intake with alcohol
The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines.
The be...
Pregnancy and lactation
Pregnancy
Ativan Injection should not be used during pregnancy, especially during the first and last trimesters, unless in the judgement of the physician such administration is clinically justifiab...
Effects on ability to drive and use machines
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traf...
Undesirable effects
Blood and lymphatic system disorders
Frequency not known:
Thrombocytopenia, agranulocytosis, pancytopenia
Immune system disorders
Frequency not known:
Hypersensitivity reactions, anaphylactic/oid...
Overdose
In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
Overdosage of benzodiazepines is usually manifested by degrees of central nervous...
Pharmacodynamic properties
Pharmacotherapeutic group:
Benzodiazepine derivatives
ATC code:
N05BA06
Ativan is a benzodiazepine with anxiolytic, sedative, hypnotic, anticonvulsant and muscle relaxant properties.
Pharmacokinetic properties
Absorption
Ativan Injection is readily absorbed when given intramuscularly. Peak plasma concentrations occur approximately 60-90 minutes following intramuscular administration.
Metabolism
Ativan is...
Preclinical safety data
Lorazepam glucuronide, the major metabolite of lorazepam, has no demonstrable CNS activity in animals.
Carcinogenicity
No evidence of carcinogenic potential emerged in rats and mice during an 18-mo...
List of excipients
Polyethylene glycol 400
Benzyl alcohol
Propylene glycol
Incompatibilities
Not applicable.
Shelf life
1 year.
Special precautions for storage
Store and transport refrigerated (2°C to 8°C).
Keep ampoule in the outer carton to protect from light.
Nature and contents of container
1ml solution in 2ml ampoules (Type I glass) with a one-point-cut opening, position marked by red spot in pack sizes of 10.
Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1279
Date of first authorization / renewal of the authorization
Date of latest renewal: 12 March 2009
Date of revision of the text
02/2019
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