DIAMORPHINE HYDROCHLORIDE Tablet (2018)
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
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
Diamorphine Hydrochloride 10mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10mg Diamorphine Hydrochloride. Excipients with known effect: Sucrose: 2.4 mg per tablet. Lactose: 107 mg per tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
White uncoated tablet with a single break line. The tablet can be divided into equal doses.
Therapeutic indications
Diamorphine hydrochloride is indicated for the relief of severe pain associated with terminal illness, acute myocardial infarction, left ventricular pain and acute pulmonary oedema.
Posology and method of administration
It is important that dosage be suited to the individual patient, taking into account the properties of the drug, the nature of the pain, the total condition of the patient and previous or concurrent medication. ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Acute respiratory depression or Chronic Obstructive Airways Disease. Biliary colic. Phaeochromocytoma. Asthma attack. ...
Special warnings and precautions for use
The risk of respiratory depression and further elevation of CSF pressure is increased if diamorphine is administered to patients with head injuries or raised intracranial pressure. The sedation and pupillary ...
Interaction with other medicinal products and other forms of interaction
Alcohol: Enhanced sedative and hypotensive effects. Antidepressants: The use of diamorphine should be avoided or used with caution in patients receiving monoamine oxidase inhibitors (including phenelzine ...
Pregnancy and lactation
There is no evidence of safety in human pregnancy, therefore it is not advisable to administer diamorphine during pregnancy. Use during labour is not advisable due to the risk of respiratory depression ...
Effects on ability to drive and use machines
May cause drowsiness, if affected patients should not drive or operate machinery. This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is ...
Undesirable effects
Hallucinations, confusion, mood changes, dysphoria and dependence. Headache, vertigo, dizziness and drowsiness. Sweating and postural hypotension. Miosis. Bradycardia, palpitations, tachycardia and facial ...
Overdose
Symptoms of severe overdosage are respiratory depression, coma or stupor, muscle flaccidity, cold clammy skin, constricted pupils and occasionally bradycardia and hypotension. Circulatory failure and pulmonary ...
Pharmacodynamic properties
Natural opium alkaloids ATC Code: N07BC06 Diamorphine is a powerful narcotic analgesic obtained from opium which acts mainly on the central nervous system and smooth muscle. It can provoke the release ...
Pharmacokinetic properties
Oral administration of diamorphine results in measurable blood concentrations of morphine but not diamorphine or 6-acetylmorphine. The amount of circulating morphine provided by an oral dose of diamorphine ...
Preclinical safety data
Preclinical information has not been included because the safety profile of diamorphine hydrochloride has been established after many years of clinical use. Please refer to section 4.
List of excipients
Sucrose Lactose Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store below 30°C. Keep the glass bottle in the outer carton in order to protect from light. Keep this medicine out of the sight and reach of children.
Nature and contents of container
Tablet container: Amber glass bottle containing 100 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG
Marketing authorization number(s)
PL 12064/0001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15<sup>th</sup> October 1992 Date of latest renewal: 3<sup>rd</sup> February 2004
Date of revision of the text
22/08/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
