Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
articaine hydrochloride, Quantity: 88 mg; adrenaline (epinephrine) acid tartrate, Quantity: 0.02 mg (Equivalent: adrenaline (epinephrine), Qty 0.011 mg)
Specialites Septodont Pty Ltd
adrenaline (epinephrine) acid tartrate,Articaine hydrochloride
Injection, solution
Excipient Ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections
Dental
50 cartridges
(S4) Prescription Only Medicine
? SEPTANEST 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. ? SEPTANEST 1:200,000 is indicated only for dental procedures
Visual Identification: Clear aqueous solution in a Type 1 glass cartridge fitted with a rubber closure ("seal") and a rubber plunger; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-10-07
1 WHAT IS IN THIS LEAFLET WHAT IS SEPTANEST 1:200,000 AND SEPTANEST 1:100,000 USED FOR BEFORE YOU ARE GIVEN SEPTANEST 1:200,000 OR SEPTANEST 1:100,000 SEPTANEST 1:200,000 AND SEPTANEST 1:100,000 _Articaine hydrochloride and Adrenaline (epinephrine) acid tartrate _ _ _ CONSUMER MEDICINE INFORMATION Please read this leaflet carefully before you use SEPTANEST 1:200,000 or SEPTANEST 1:100,000. This leaflet answers some common questions about SEPTANEST 1:200,000 or SEPTANEST 1:100,000. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking SEPTANEST 1:200,000 or SEPTANEST 1:100,000 against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. SEPTANEST 1:200,000 and SEPTANEST 1:100,000 contain the active ingredients: Articaine hydrochloride, a local anaesthetic to prevent the pain, and Adrenaline (epinephrine) acid tartrate, a vasoconstrictor, which makes it last longer (adrenaline narrows the blood vessels at the site of injection, which keeps the anaesthetic where it's needed for a longer time) and controls bleeding during the surgery. SEPTANEST 1:200,000 and SEPTANEST 1:100,000 belong to a group of medicines called local anaesthetics. SEPTANEST 1:200,000 or SEPTANEST 1:100,000 is injected into the mouth where it makes the nerves unable to pass messages to the brain. Your dentist will have explained why you are being given SEPTANEST 1:200,000 or SEPTANEST 1:100,000. Follow all directions given to you by your dentist carefully. They may differ from the information contained in this leaflet. Ask your dentist if you want more information. SEPTANEST 1:200,000 and SEPTANEST 1:100,000 are not addictive. When you must not be given SEPTANEST read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – SEPTANEST 1:100,000 AND SEPTANEST 1:200,000 (ARTICAINE HYDROCHLORIDE , ADRENALINE(EPINEPHRINE) ACID TARTRATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Articaine hydrochloride with adrenaline (epinephrine) acid tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SEPTANEST 1:100,000: articaine hydrochloride 4% with adrenaline (epinephrine) acid tartrate 1:100,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline (epinephrine) 10µg/mL] SEPTANEST 1:200,000: articaine hydrochloride 4% with adrenaline (epinephrine) acid tartrate 1:200,000 [i.e. articaine hydrochloride 40 mg/mL with adrenaline (epinephrine) 5µg/mL] SEPTANEST 1:100,000 Per 1.7 mL cartridge Per 2.2 mL cartridge ACTIVE INGREDIENTS Articaine hydrochloride (INN) 68.0 mg 88.0 mg Adrenaline (epinephrine) (as acid tartrate) 17.0 µg 22.0 µg OTHER INGREDIENTS Sodium chloride 2.72 mg 3.52 mg Sodium metabisulfite 0.85 mg 1.1 mg Sodium hydroxide solution (to adjust pH) Water for injection q.s ad 1.7 mL 2.2 mL Contains no antimicrobial agent. SEPTANEST 1:200,000 Per 1.7 mL cartridge Per 2.2 mL cartridge ACTIVE INGREDIENTS Articaine hydrochloride (INN) 68.0 mg 88.0 mg Adrenaline (epinephrine) (as acid tartrate) 8.5 µg 11.0 µg OTHER INGREDIENTS Sodium chloride 2.72 mg 3.52 mg Sodium metabisulfite 0.85 mg 1.1 mg Sodium hydroxide solution (to adjust pH) Water for injection q.s ad 1.7 mL 2.2 mL Contains no antimicrobial agent. Articaine hydrochloride is a local anaesthetic Adrenaline (epinephrine) acid tartrate is a vasoconstrictor. 2 3 PHARMACEUTICAL FORM SEPTANEST 1:100 000 is a Clear, not opalescent, colourless solution for injection cartridge, practically free from visible particles. It is available in a 1.7mL or 2.2mL cartridge. SEPTANEST 1:200 000 is a Clear, not opalescent, colourless solution for injection cartridge, practically free from visible particles. It is available in a 1.7mL or 2.2mL cartridge. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS SEPTANEST 1:100,000 is indicated for local or regional ana read_full_document