Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: DIAZEPAM Rectal solution (2017)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Diazepam RecTubes 10mg Rectal Solution.

Qualitative and quantitative composition

Diazepam Ph Eur 10mg in 2.5ml (4mg/ml). Excipients: each 2.5ml dose contains Benzoic acid (E210) 2.5mg, Sodium benzoate (E211) 122.5mg and Propylene glycol 1000mg. For the full list of excipients, see ...

Pharmaceutical form

Rectal solution. A clear, colourless or almost yellow solution.

Therapeutic indications

Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, ...

Posology and method of administration

Posology Sensitivity to diazepam varies with age. Children above 1 year of age: 0.5 mg/kg body weight. Adults: 0.5 mg/kg body weight. Elderly patients: 0.25 mg/kg body weight. A maximum dose of 30 mg diazepam ...

Contraindications

Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1. Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur). ...

Special warnings and precautions for use

Tolerance Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks. Dependence Use of benzodiazepines may lead to the development of physical and psychic ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions If diazepam is used with other centrally acting agents, careful consideration has to be given to the pharmacology of the agents employed, particularly with compounds that may ...

Fertility, pregnancy and lactation

In animal studies administration of benzodiazepines during gestation has lead to cleft palate, CNS malformation and permanent functional disturbances in the offspring. Pregnancy There is no evidence as ...

Effects on ability to drive and use machines

Sedation, amnesia, impaired muscular function may adversely effect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also Interactions). ...

Undesirable effects

Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly occur at the start of therapy but usually disappear with ...

Overdose

Features The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Diazepam ATC code: N05BA01 Diazepam has anticonvulsant, sedative and muscle relaxant properties. Diazepam binds to specific receptors in the central nervous system and particular ...

Pharmacokinetic properties

After rectal administration of the solution, diazepam is absorbed rapidly and almost completely from the rectum. The onset of the therapeutic effect occurs within a few minutes of rectal administration. ...

Preclinical safety data

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

List of excipients

Benzyl alcohol Ethanol 96% Propylene glycol Benzoic acid Sodium benzoate Purified Water

Incompatibilities

None known.

Shelf life

Shelf life: Three years. Once foil is opened, use immediately.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Packs of 2 or 5 rectal tubes each containing 2.5ml of solution The tubes are made of low-density polyethylene. The tubes have a nozzle attached for application. Each tube is individually presented in a ...

Special precautions for disposal and other handling

For single use only.

Marketing authorization holder

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

Marketing authorization number(s)

PL 29831/0066

Date of first authorization / renewal of the authorization

06/05/2008

Date of revision of the text

26/04/2017

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 141,4 KB