GRANISETRON Concentrate for solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Granisetron 1 mg/ml concentrate for solution for injection or infusion.
Qualitative and quantitative composition
The active substance is granisetron hydrochloride. 1ml concentrate for solution for injection or infusion contains 1.12 mg granisetron hydrochloride equivalent to 1 mg granisetron. 3 ml concentrate for ...
Pharmaceutical form
Concentrate for solution for injection or infusion. The solution for injection is a clear, colourless liquid.
Therapeutic indications
Granisetron is indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. post-operative nausea and vomiting. Granisetron is indicated ...
Posology and method of administration
Posology Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) Prevention (acute and delayed nausea and vomiting) A dose of 1–3 mg (10–40 µg/kg) of Granisetron should be administered either ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration. As for other 5-HT<sub>3</sub> antagonists, ECG ...
Interaction with other medicinal products and other forms of interaction
As for other 5-HT<sub>3</sub> antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron. In patients concurrently treated with medicinal products known to prolong ...
Fertility, pregnancy and lactation
Pregnancy There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Granisetron has no or negligible influence on the ability to drive or to use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions for granisetron are headache and constipation which may be transient. ECG changes including QT prolongation have been reported ...
Overdose
There is no specific antidote for granisetron. In the case of overdose with the injection or infusion, symptomatic treatment should be given. Doses of up to 38.5 mg of granisetron as a single injection ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5-HT<sub>3</sub>) antagonists ATC code: A04AA02 Neurological mechanisms, serotonin-mediated nausea and vomiting Serotonin is the main ...
Pharmacokinetic properties
Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults. It is clear from the extensive dose-finding programme that the antiemetic efficacy is not unequivocally ...
Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity. Carcinogenicity studies revealed ...
List of excipients
Sodium chloride Citric acid monohydrate Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
3 years. The product should be used immediately after opening. For single use only. Discard any remaining portion. Shelf life after Dilution: Chemical and physical in-use stability has been demonstrated ...
Special precautions for storage
This product does not require any special temperature storage conditions. Keep the ampoules in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product ...
Nature and contents of container
1 and 3 ml colourless ampoules. Pack sizes: 5 1 ml, 10 1 ml, 5 3 ml and 10 3 ml Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Preparing the infusion Adults The contents of a 1 ml ampoule can be diluted to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted to a volume of 15 ml. Granisetron can also be diluted in 20-50 ...
Marketing authorization holder
hameln pharma plus gmbh, Langes Feld 13, 31789, Hameln, Germany
Marketing authorization number(s)
PL 25215/0019
Date of first authorization / renewal of the authorization
Date of first authorisation: 04/07/2008 Date of latest renewal: 11/05/2013
Date of revision of the text
08/05/2019
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