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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Largactil Injection (2012)

Εκδότης

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Περιεχόμενα

Name of the medicinal product

Largactil 25mg/ml Solution for Injection.

Qualitative and quantitative composition

25mg/ml chlorpromazine hydrochloride. For full list of excipients see section 6.1

Pharmaceutical form

Sterile solution for injection. A clear, colourless or almost colourless solution.

Therapeutic indications

Largactil injection is a phenothiazine neuroleptic. It is indicated in the following conditions: Schizophrenia ...

Posology and method of administration

Route of administration: Deep intramuscular injection. Oral route administration should be used wherever ...

Contraindications

Known hypersensitivity to chlorpromazine or to any of the excipients. Bone marrow depression.

Special warnings and precautions for use

Largactil should be avoided in patients with liver or renal dysfunction, Parkinsons disease, hypothyroidism, ...

Interaction with other medicinal products and other forms of interaction

Adrenaline must not be used in patients overdosed with Largactil. The CNS depressant actions of Largactil ...

Pregnancy and lactation

There is inadequate evidence of the safety of Largactil in human pregnancy. There is evidence of harmful ...

Effects on ability to drive and use machines

Patients should be warned about drowsiness during the early days of treatment and advised not to drive ...

Undesirable effects

Generally, adverse reactions occur at low frequency; the most common reported adverse reactions are nervous ...

Overdose

Toxicity and treatment of overdosage: Symptoms of chlorpromazine overdosage include drowsiness or loss ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Antipsychotics ATC Code: N05AA01 Largactil is a phenothiazine neuroleptic. ...

Pharmacokinetic properties

Chlorpromazine is rapidly absorbed and widely distributed in the body. It is metabolised in the liver ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

Sodium sulphite anhydrous (E221) Sodium citrate Sodium metabisulphite (E223) Sodium chloride Water for ...

Incompatibilities

Largactil injection solutions have a pH of 5.0-6.5; they are incompatible with benzylpenicillin potassium, ...

Shelf life

The shelf life of the Largactil Injection is 60 months.

Special precautions for storage

Keep ampoules in outer carton in order to protect from light. Discoloured solution should not be used. ...

Nature and contents of container

Largactil Injection 2.5% w/v is supplied in boxes containing 10 2 ml in glass ampoules.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS United Kingdom

Marketing authorization number(s)

PL 04425/0582

Date of first authorization / renewal of the authorization

Date of First Authorisation: 24 April 2007

Date of revision of the text

6 December 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.