GENTAMICIN Eye / Ear drops (2015)
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
Gentamicin Eye/Ear Drops 0.3% W/V.
Qualitative and quantitative composition
Active Ingredient: Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution.
Pharmaceutical form
Eye/Ear Drops.
Therapeutic indications
Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis ...
Posology and method of administration
Eye: Instill 1-2 drops into the affected eye every four hours as required. Ears: The area should be cleansed and 2-4 drops instilled 3-4 times daily.
Contraindications
Should not be administered to patients with a known allergy to gentamicin and other aminoglycosides. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in ...
Special warnings and precautions for use
Avoid prolonged use. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross-sensitivity with other aminoglycoside antibiotics may occur. In severe infections, topical ...
Interaction with other medicinal products and other forms of interaction
Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity whilst amphotericin B, cisplatin and cyclosporin and cephalosporins are potential enhancers of nephrotoxicity. ...
Pregnancy and lactation
There are no proven cases of intrauterine damage caused by gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life-threatening situations ...
Effects on ability to drive and use machines
Patients should be advised that the use of gentamicin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.
Undesirable effects
There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as frequency unknown. Eye Disorders: ...
Overdose
Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused ...
Pharmacodynamic properties
Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin. Gentamicin ...
Pharmacokinetic properties
Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its ...
Preclinical safety data
Nothing of relevance which is not included in other sections of the SPC.
List of excipients
Sodium chloride Disodium edetate Sodium metabisulphite Borax Benzalkonium chloride solution Purified water Sodium hydroxide soluion (pH adjuster) Hydrochloric acid (pH adjuster)
Incompatibilities
Pharmaceutically incompatible with amphotericin, cephalosporins, erythromicin, heparin, penicillins, sodium bicarbonate and sulphadiazine sodium.
Shelf life
Shelf life Unopened: 24 months. Opened: 28 days.
Special precautions for storage
Protect from light. Store below 25°C
Nature and contents of container
10ml low density polyethylene bottle with polystyrene spiked cap.
Marketing authorization holder
FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hants, PO15 7FE
Marketing authorization number(s)
PL 15872/0004
Date of first authorization / renewal of the authorization
22 January 1998 / 18 March 2003
Date of revision of the text
10 June 2015
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
