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SPC, UK: ATIVAN Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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 contains 20.9mg/ml ...

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 acute mania. ...

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 Treatment in all patients should be withdrawn gradually ...

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 insufficiency. ...

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 injection ...

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 benzodiazepines, ...

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 justifiable. ...

Effects on ability to drive and use machines

This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. ...

Undesirable effects

Blood and lymphatic system disorders Frequency not known: Thrombocytopenia, agranulocytosis, pancytopenia Immune system disorders Frequency not known: Hypersensitivity reactions, anaphylactic/oid reactions ...

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 system ...

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 metabolised ...

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-month ...

List of excipients

Polyethylene glycol 400 Benzyl alcohol Propylene glycol

Incompatibilities

Not applicable.

Shelf life

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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