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SPC, UK: DIAZEPAM Solution for injection (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Diazepam 5mg/ml Solution for Injection.

Qualitative and quantitative composition

Diazepam 5mg/ml. Excipients – Contains Benzoic acid (E210) 1mg/ml, Ethanol 96% 100mg/ml, Sodium benzoate (E211) 49mg/ml, Benzyl alcohol 15mg/ml, Propylene glycol 400mg/ml and Sodium Content – 0.34mmol/ml. ...

Pharmaceutical form

Solution for Injection. Clear, colourless to pale yellow liquid.

Therapeutic indications

Diazepam injection may be used in severe or disabling anxiety and agitation; for the control of status epilepticus, epileptic and febrile convulsions; to relieve muscle spasm; as a sedative in minor surgical ...

Posology and method of administration

Dosage depends on individual response, age and weight. Adults In severe anxiety or acute muscle spasm, diazepam 10mg may be given intravenously or intramuscularly and repeated after 4 hours. In tetanus, ...

Contraindications

Known sensitivity to benzodiazepines or any of the ingredients. Severe or acute respiratory insufficiency/depression. Sleep apnoea syndrome. Severe hepatic insufficiency. Avoid injection in neonates (contains ...

Special warnings and precautions for use

Diazepam injection should be used with caution in patients with renal or hepatic dysfunction (see 4.2 Posology and Method of Administration), chronic pulmonary insufficiency, porphyria, muscle weakness, ...

Interaction with other medicinal products and other forms of interaction

Alcohol Enhanced sedation or respiratory or CNS depression with concomitant administration of diazepam. Concomitant use should be avoided. General anaesthetics and narcotic analgesics Enhanced sedation ...

Pregnancy and lactation

There is no evidence regarding the safety of diazepam in pregnancy, however, diazepam and its metabolite desmethyldiazepam freely cross the placenta and accumulate in the fetal circulation. It should not ...

Effects on ability to drive and use machines

Patients treated with Diazepam Injection should not drive or use machinery. This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is in the ...

Undesirable effects

The side effects of diazepam are usually mild and infrequent. Blood and lymphatic system disorders: Blood dyscrasias including thrombocytopenia and agranulocytosis have been reported with diazepam. Immune ...

Overdose

Symptoms The symptoms of mild overdose may include confusion, impairment of consciousness with somnolence or a sleep-like state, little or no respiratory depression, ataxia, dysarthria, nystagmus, hypotension, ...

Pharmacodynamic properties

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, ...

Pharmacokinetic properties

Diazepam is highly lipid soluble and crosses the blood brain barrier. These properties qualify it for intravenous use in short term anaesthetic procedures since it acts promptly on the brain, and its initial ...

Preclinical safety data

Chronic toxicity studies have demonstrated no evidence of drug induced changes. There are no long term animal studies to investigate the carcinogenic potential of diazepam. Several investigations pointed ...

List of excipients

Benzoic acid (E210) Ethanol Propylene glycol Sodium benzoate (E211) Benzyl alcohol Water for Injections

Incompatibilities

Diazepam Injection should not be mixed with other drugs in the same infusion solution or the same syringe.

Shelf life

Shelf life: Three years. For single use only. Discard any remaining contents.

Special precautions for storage

Keep container in the outer carton to protect from light. Do not store above 25°C.

Nature and contents of container

Amber Type I PhEur glass ampoules (2ml or 4ml) packed in 10s in an outer printed carton.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization number(s)

PL 29831/0065

Date of first authorization / renewal of the authorization

Date of first authorisation: 30/05/1985 Date of latest renewal: 09/03/2005

Date of revision of the text

01/02/2016

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