Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
prilocaine hydrochloride, Quantity: 30 mg/mL; felypressin, Quantity: 0.54 microgram/mL
Dentsply Sirona Pty Ltd
Felypressin,Prilocaine hydrochloride
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide
Subcutaneous, Infiltration, Intramuscular
1.8 mL x 100, 1.8 mL x 50
(S4) Prescription Only Medicine
INDICATIONS AS AT 23 JULY 2003 : CITANEST is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block tecniques.
Visual Identification: Clear colourless particle-free solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-05-26
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 Read the complete document
3% CITANEST ® DENTAL WITH OCTAPRESSIN ® PRODUCT INFORMATION DENTSPLY SIRONA PTY LTD AU-PI Revision 5.0 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION 3% CITANEST ® DENTAL WITH OCTAPRESSIN ® (prilocaine hydrochloride and felypressin) 1 NAME OF THE MEDICINE prilocaine hydrochloride felypressin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3% Citanest DENTAL with Octapressin is a clear, colourless sterile aqueous 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 injection solution in a standard and self- aspirating glass cartridge. The finished product is a clear and colourless solution packed in a carton containing either 50 or 100 units of 1.8 mL and 2.2 mL Type I 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3% Citanest DENTAL with Octapressin is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. 4.2 DOSE AND METHOD OF ADMINISTRATION The lowest dosage that results in effective anaesthesia should be used. The dosage will also depend on the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia. RECOMMENDED DOSAGE FOR 3% CITANEST DENTAL WITH OCTAPRESSIN (0.03 IU/mL or 0.54 μg/mL felypressin) SOLUTION FOR DENTAL ANAESTHETIC PROCEDURES IN THE AVERAGE, HEALTHY, 70KG ADULT PATIENT 3% CITANEST ® DENTAL WITH OCTAPRESSIN ® PRODUCT INFORMATION DENTSPLY SIRONA PTY LTD AU-PI Revision 5.0 Page 2 of 10 3% CITANEST ® DENTAL WITH OCTAPRESSIN ® INFILT BLOCK SUGGESTED DOSE 1 mL 1.5 – 2 mL ONSET OF ACTION (APPROX) 2 min 4 min DURATION OF ACTION (APPROX) Pulp Soft Tissue 40 min 2.5 hrs 90 min 3.5 hrs NOTE: 1. RECOMMENDED DOSES Toxic doses vary widely bet Read the complete document