Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Felypressin 0.54 µg/mL; Prilocaine hydrochloride 3% (30mg/ml.);
Dentsply Sirona (NZ) Limited
Felypressin 0.03 IU/mL (0.46µg/ml.)
Solution for injection
Active: Felypressin 0.54 µg/mL Prilocaine hydrochloride 3% (30mg/ml.) Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Cartridge, glass, Self aspirating 100x1.8mL, 180 mL
Prescription
Prescription
PolyPeptide Laboratories AB
Infiltration anaesthesia in dentistry, where there is no need for profound ischaemia in the injected area.
Package - Contents - Shelf Life: Cartridge, glass, 50x1.8mL - 90 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Self aspirating 50x1.8mL - 90 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Aspirating, 50x2.2mL - 110 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 50x2.2mL - 110 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 100x1.8mL - 180 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Self aspirating 100x1.8mL - 180 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, Aspirating, 100x2.2mL - 220 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Cartridge, glass, 100x2.2mL - 220 mL - 24 months from date of manufacture stored at or below 25°C protect from light
1969-12-31
CITANEST ® DENTAL WITH OCTAPRESSIN ® 1 3% CITANEST ® DENTAL WITH OCTAPRESSIN ® _Prilocaine Hydrochloride with Felypressin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Citanest DENTAL with Octapressin. It does not contain all the available information. It does not take the place of talking to your dental practitioner or dental nurse. All medicines have risks and benefits. Your dental practitioner has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DENTAL PRACTITIONER. KEEP THIS LEAFLET. You may need to read it again. WHAT CITANEST DENTAL WITH OCTAPRESSIN IS USED FOR Citanest DENTAL with Octapressin is used to prevent or relieve pain during dental procedures, but it will not put you to sleep.This medicine belongs to a group of medicines called local anaesthetics. It is injected into the gums and works by making the nerves unable to pass pain messages to the brain. Depending on the amount used, it will either totally stop pain or will cause a partial loss of feeling. The felypressin makes the blood vessels at the site of injection narrower, which means you bleed less. It is then easier for your dental practitioner to see what is happening. ASK YOUR DENTAL PRACTITIONER IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is not addictive. BEFORE YOU ARE GIVEN CITANEST DENTAL WITH OCTAPRESSIN _WHEN YOU MUST NOT BE GIVEN _ _IT _ DO NOT TAKE CITANEST DENTAL WITH OCTAPRESSIN IF YOU HAVE AN ALLERGY TO: • any medicine containing prilocaine • any of the ingredients listed at the end of this leaflet • any other similar medicines, such as other local anaesthetics e.g. Xylocaine. Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO Olvassa el a teljes dokumentumot
3% CITANEST ® DENTAL WITH OCTAPRESSIN ® DATA SHEET DENTSPLY SIRONA (NZ) LTD NEW ZEALAND DATA SHEET 1 PRODUCT NAME 3% Citanest ® DENTAL with Octapressin ® Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3% Citanest ® DENTAL with Octapressin ® injection solution contains 30 mg/mL prilocaine hydrochloride and 0.54 micrograms/mL felypressin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 3% Citanest ® DENTAL with Octapressin ® is a sterile aqueous solution. The pH of the solution is 3.5-5.2. 3% Citanest ® DENTAL with Octapressin ® injection solution in a standard and self-aspirating glass cartridge. The finished products is a clear and colourless solution packed in a carton containing 100 units of 1.8 mL or 2.2 mL Type 1 glass cartridges, closed on one end with a self-aspirating bromobutyl rubber plunger and at the other end by a bromobutyl disk covered by an aluminium cap. The ampoules and cartridges are free from preservatives and are intended for single use only. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Infiltration anaesthesia in dentistry, where there is no need for profound ischaemia in the injected area. • Regional nerve block anaesthesia in dentistry. 4.2 DOSE AND METHOD OF ADMINISTRATION 3% Citanest ® DENTAL with Octapressin ® has a rapid onset of action after infiltration anaesthesia, with an average of 2-3 minutes. Inferior alveolar nerve block requires 5 minutes or more to take full effect. The duration of effective anaesthesia varies in individuals and depends on the type of block. The average duration of useful anaesthesia after infiltration is 45 minutes. After successful regional block, e.g. inferior alveolar nerve block, anaesthesia lasts for 2 hours or longer. Injections should always be made slowly with careful aspiration before and intermittently during injection to avoid inadvertent intravascular injection, which may have toxic effects. The lowest dose that results in effective anaesthesia should be used. The dose will a Olvassa el a teljes dokumentumot