LIOTON Gel (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
1. Name of the medicinal product
Lioton 1000 gel.
2. Qualitative and quantitative composition
1g of gel contains heparin 1,000 I.U. <u>Excipient(s) with known effect:</u> Lioton 1000 gel contains the excipients methyl- and propyl p-hydroxybenzoate and it should not be used in patients with paraben ...
3. Pharmaceutical form
Gel. Colourless, almost transparent gel with aromatic odour.
4.1. Therapeutic indications
Treatment of superficial venous affections such as varicose syndromes and their complications, phlebothrombosis, thrombophlebitis, superficial periphlebitis, varicose ulcers. Postoperative varicophlebitis; ...
4.2. Posology and method of administration
Posology One to three applications a day. Apply 3-10 cm of gel on the affected area and massage gently. Pediatric population Due to the limited experience and available data, it should not be used in children. ...
4.3. Contraindications
Lioton 1000 gel should not be used in cases of known hypersensitivity to heparin or any of the other ingredients of the product.
4.4. Special warnings and precautions for use
The use of Lioton 1000 gel in the presence of haemorrhagic phenomena should be closely evaluated. Lioton 1000 gel should not be applied in cases of bleeding, on open wounds or on mucosae, nor on sites ...
4.5. Interaction with other medicinal products and other forms of interaction
The use of heparin can further prolong prothrombin time in patients treated with oral anticoagulants.
4.6. Fertility, pregnancy and lactation
No specific data on the use of this medicinal product during pregnancy and lactation are available.
4.7. Effects on ability to drive and use machines
Lioton 1000 gel does not affect alertness and therefore does not exert an effect on the ability to drive vehicles or use machinery.
4.8. Undesirable effects
Allergic reactions to heparin following application onto the skin are very rare. However, hypersensitivity reactions such as reddening of the skin and itching, which usually disappear rapidly upon withdrawal, ...
4.9. Overdose
No overdose phenomena have been reported to date. In case of overdose, heparin effect can be neutralised by protamine sulphate.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivaricose therapy, Heparins or heparinoids for topical use <b>ATC code:</b> C05BA03 Experimental pharmacological data demonstrate that Lioton 1000 gel administered ...
5.2. Pharmacokinetic properties
Pharmacokinetic tests conducted in the rat have shown that heparin concentrations are detectable in the plasma for up to 24 hours after administration, with peak levels being reached after eight hours. ...
5.3. Preclinical safety data
Acute toxicology tests conducted in the mouse and in the rat have demonstrated that Lioton 1000 gel has a very low s.c. and i.p. toxicity (LD<sub>50</sub> 2000 mg/kg). Subchronic and chronic treatment ...
6.1. List of excipients
Carbomer, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethanol 96%, neroli fragrance, lavandin oil, trolamine, purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Folding box containing 30g or 50g tube of gel. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
A. Menarini Industrie Farmaceutiche Riunite S.r.l., Via Sette Santi 3, 50131, Firenze Italy, Tel.: 0039 055 5680336
8. Marketing authorization number(s)
013373
9. Date of first authorization / renewal of the authorization
Date of first authorization: 04 June 1991 Date of latest renewal: 02 May 2011
10. Date of revision of the text
23/03/21
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
