SALAGEN Film-coated tablet (2019)
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
Salagen 5 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 5 mg of pilocarpine hydrochloride. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Salagen film-coated tablets are white, round biconvex tablets, marked SAL on one side and 5 on the other side.
Therapeutic indications
Alleviation of symptoms of salivary gland hypofunction in patients with severe xerostomia following irradiation for head and neck cancer. *Treatment of symptoms of dry mouth and dry eyes in patients with ...
Posology and method of administration
Posology For head and neck cancer patients The recommended initial dose for adults is 1 tablet of 5 mg three times daily. The maximal therapeutic effect is normally obtained after 4 to 8 weeks of therapy. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Salagen is contraindicated in patients with clinically significant, uncontrolled cardiorenal disease, uncontrolled ...
Special warnings and precautions for use
Caution should be exercised in patients who are known or expected to sweat excessively and who cannot drink enough liquids, since dehydration could develop. Pilocarpine has been reported to increase airway ...
Interaction with other medicinal products and other forms of interaction
Salagen should be administered with caution to patients taking beta adrenergic antagonists because of the possibility of conduction disturbances. Concurrent administration of Salagen and drugs with parasympathomimetic ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established. There are no known human data for the effects of pilocarpine on foetal survival and development. Studies ...
Effects on ability to drive and use machines
Patients who experience dizziness during Salagen treatment should be advised not to drive or operate machinery. Pilocarpine has been reported to cause impairment of depth perception and visual blurring. ...
Undesirable effects
Most of the adverse experiences observed during Salagen treatment were a consequence of exaggerated parasympathetic stimulation. These adverse experiences were dose-dependent and usually mild and self-limited. ...
Overdose
Overdose may lead to a cholinergic crisis characterised by both muscarinic and nicotinic effects. Signs of overdose due to muscarinic effects may include abdominal cramps, diarrhoea, nausea and vomiting, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Parasympathominetic ATC code: N07AX01 Mechanism of action Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant ...
Pharmacokinetic properties
Absorption In a multiple-dose pharmacokinetic study in volunteers given 5 or 10 mg of pilocarpine hydrochloride three times daily for two days, the T<sub>max</sub> after the final dose was approximately ...
Preclinical safety data
Genotoxicity and carcinogenicity: Pilocarpine did not indicate a genotoxic potential in a series of in vitro and in vivo genotoxicity studies. In lifetime oral carcinogenicity studies in rodents Pilocarpine ...
List of excipients
<u>Binder/diluent:</u> Microcrystalline cellulose <u>Acidifier/lubricant:</u> Stearic acid <u>Film coating:</u> Opadry White, OY-7300, containing hypromellose, macrogol 400 and titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
Salagen is distributed for sale in perforated Al/PVC/PVDC blisters. Each blister contains 14 or 21 tablets. A carton contains 1, 2 or 6 of the 14-tablet blisters, or 1 or 4 of the 21-tablet blisters. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
Marketing authorization number(s)
PL 20011/0069
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 July 2001 Date of last renewal: 01 July 2006
Date of revision of the text
May 19
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
