GRANISETRON Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Granisetron 1 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 1 mg granisetron (as hydrochloride). Excipient with known effect: Each tablet contains 55.78 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to off-white tablet embossed GS on one side and plain on the reverse.
Therapeutic indications
Granisetron tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. Granisetron tablets are indicated in adults for ...
Posology and method of administration
Posology 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of granisetron should be administered within one hour before the start of therapy. ...
Contraindications
Granisetron is contra-indicated in patients hypersensitive 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 administration of granisetron. As for other 5-HT<sub>3</sub> antagonists, ...
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 and 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 tablets, symptomatic treatment should be given. Doses of up to 38.5 mgof granisetron as a single injection have been reported, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT<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
<u>Tablet core:</u> Lactose Monohydrate Cellulose, Microcrystalline Hypromellose Sodium Starch Glycolate (type A) Magnesium Stearate <u>Film coat:</u> Titanium Dioxide (E171) Hypromellose Macrogol 400 ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
This product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC aluminium foil opaque blisters in a cardboard carton and HDPE bottle with PE cap containing 1,2,4,5,6,7,10,14,20,28,30,50,90,100,150,200,250 and 500 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Marketing authorization number(s)
PL 04569/0688
Date of first authorization / renewal of the authorization
26/10/2005
Date of revision of the text
11/2018
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