Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Adrenaline 0.005 mg/mL equivalent to 0.006 mg adrenaline hydrochloride; Articaine hydrochloride 40 mg/mL;
3M New Zealand Ltd
Adrenaline 0.005 mg/mL (equivalent to 0.006 mg adrenaline hydrochloride)
4%/1:200,000
Solution for injection
Active: Adrenaline 0.005 mg/mL equivalent to 0.006 mg adrenaline hydrochloride Articaine hydrochloride 40 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium sulfite Water for injection
Cartridge, glass, 50 x 1.7 mL, 50 dose units
Prescription
Prescription
Cambrex Profarmaco Milano Srl
Infiltration anaesthesia and nerve block anaesthesia in dentistry. UBISTESIN FORTE is especially indicated for more complex dental procedures requiring prolonged anaesthesia.
Package - Contents - Shelf Life: Cartridge, glass, 50 x 1.7 mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
2006-03-03
NEW ZEALAND DATA SHEET Ubistesin and Ubistesin Forte CCDSv3 DSv4-08mar19 Page 1 of 19 1 PRODUCT NAME UBISTESIN 1/200 000 solution for injection UBISTESIN FORTE 1/100 000 solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amount per 1.7 mL cartridge COMPONENT UBISTESIN 1/200 000 UBISTESIN FORTE 1/100 000 ACTIVE INGREDIENTS: Articaine hydrochloride 68 mg 68mg Adrenaline (epinephrine) hydrochloride _Equivalent _ _to _ _adrenaline _ _(epinephrine) _ 0.0102 mg _ _ _ _ _0.0085 mg _ 0.0204 mg _ _ _ _ _0.017 mg _ EXCIPIENTS WITH KNOWN EFFECT: Sodium chloride 1.91 mg 1.91 mg Sodium sulfite 1.02 mg 1.02 mg The cartridges contain sodium sulfite as an antioxidant and are free from preservatives. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM UBISTESIN and UBISTESIN FORTE are sterile isotonic aqueous solutions for injection. The solution is a clear, not opalescent, colourless solution, practically free from visible particles with a pH value of 3.6-4.4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infiltration anaesthesia and nerve block anaesthesia in dentistry. UBISTESIN FORTE is especially indicated for more complex dental procedures requiring prolonged anaesthesia. UBISTESIN and UBISTESIN FORTE must not be used in children under the age of 4 years. NEW ZEALAND DATA SHEET Ubistesin and Ubistesin Forte CCDSv3 DSv4-08mar19 Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION UBISTESIN and UBISTESIN FORTE are exclusively for use in dentistry . The following dosage instructions apply: The smallest possible volume of solution that will lead to effective anaesthesia should be used. Adults: For extraction of maxillary teeth, 1.7mL UBISTESIN or UBISTESIN FORTE per tooth suffices in most cases, thereby avoiding painful palatal injections. A smaller injection volume is often possible for serial extractions of neighbouring teeth. If a cut or suture is required in the palate, a palatal injection of approximately 0.1mL per puncture is indicated. For uncomplicated extractions of mandibular premola Prečítajte si celý dokument