TRAMADOL HYDROCHLORIDE HAMELN PHARMA Solution for injection or infusion (2021)
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
Tramadol hydrochloride 50 mg/ml solution for injection or infusion.
Qualitative and quantitative composition
Tramadol hydrochloride 50 mg/ml of injection solution (50 ml per 1 ml ampoule, 100 mg per 2 ml ampoule). <u>Excipient with known effect:</u> This medicine contains less than 1 mmol sodium (23 mg) per ml, ...
Pharmaceutical form
Clear, colourless sterile solution for injection or infusion.
Therapeutic indications
Treatment of moderate to severe pain.
Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal ...
Contraindications
Tramadol hydrochloride 50 mg/ml solution for injection or infusion is contraindicated in patients who have previously shown hypersensitivity to the active substance tramadol or to any of the excipients ...
Special warnings and precautions for use
Tramadol hydrochloride 50 mg/ml solution for injection or infusion may only be used with particular caution in opioiddependent patients, patients with head injury, shock, a reduced level of consciousness ...
Interaction with other medicinal products and other forms of interaction
Tramadol hydrochloride 50 mg/ml solution for injection or infusion should not be combined with MAO inhibitors (see section 4.3). In patients treated with MAO inhibitors in the 14 days prior to the use ...
Fertility, pregnancy and lactation
Pregnancy Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in a pregnant woman, advise ...
Effects on ability to drive and use machines
Even when taken according to instructions, Tramadol hydrochloride 50 mg/ml solution for injection or infusion may cause effects such as somnolence and dizziness and therefore may impair a patients ability ...
Undesirable effects
Rapid intravenous administration may be associated with a higher incidence of adverse effects and therefore should be avoided. The most commonly reported adverse drug reactions are nausea and dizziness, ...
Overdose
Symptoms Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. In principle, ...
Pharmacodynamic properties
<b>Analgesic</b> <b>ATC code:</b> N02AX02 Tramadol is a centrally acting analgesic which possesses opioid agonist properties. Tramadol consists of two enantiomers, the ( + )-isomer is predominantly active ...
Pharmacokinetic properties
a) General The mean absolute bioavailability after intramuscular administration was found to be 100%. The distribution of tramadol following intravenous administration is rapid and in two phases with different ...
Preclinical safety data
On repeated oral and parenteral administration of tramadol for 6 26 weeks in rats and dogs and oral administration for 12 months in dogs, haematological, clinico-chemical and histological investigations ...
List of excipients
Sodium acetate trihydrate Water for injections
Incompatibilities
Precipitation will occur if Tramadol hydrochloride 50 mg/ml solution for injection or infusion is mixed in the same syringe with injections of diazepam, diclofenac sodium, indomethacin, midazolam and piroxicam. ...
Shelf life
36 months. From a microbiological point of view, the product should be used immediately. If not used-immediately, inuse storage times and conditions prior to use are the responsibility of the user.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Colourless glass ampoule containing either 1 ml or 2 ml of injection solution. Ampoules are contained in a pre-fabricated blister strip, which is enclosed in a cardboard outer carton. Cartons contain either ...
Special precautions for disposal and other handling
Based on described observations Tramadol 50 mg/ml solution for injection or infusion is physically and chemically compatible for up to 24 hours with water for injections (WFI), sodium chloride solution ...
Marketing authorization holder
hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
Marketing authorization number(s)
PL 01502/0085
Date of first authorization / renewal of the authorization
01/08/2014
Date of revision of the text
12/08/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
