Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
neostigmine methylsulfate, Quantity: 2.5 mg; glycopyrronium bromide, Quantity: 0.5 mg
KSJ Pharmatech
Injection, solution
Excipient Ingredients: water for injections; citric acid; sodium hydroxide; dibasic sodium phosphate dodecahydrate
Intravenous
10 x 1 mL ampoules
(S4) Prescription Only Medicine
Reversal of residual non-depolarising (competitive) neuromuscular block.
Visual Identification: A clear, colourless, sterile solution free from visible particles and fibres; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-07-21
GLYCONEO 0.5/2.5 1 _ _ GLYCONEO 0.5/2.5 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING GLYCONEO 0.5/2.5? GLYCONEO 0.5/2.5 contains the active ingredients glycopyrronium bromide (glycopyrrolate) and neostigmine methylsulfate. GLYCONEO 0.5/2.5 is used at the end of an operation to reverse the effects of some of the medicines used during surgery such as anesthetics and muscle relaxants. For more information, see Section 1. Why am I using GLYCONEO 0.5/2.5? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GLYCONEO 0.5/2.5? Do not use if you have ever had an allergic reaction these ingredients; glycopyrronium bromide (glycopyrrolate), neostigmine methylsulfate, dibasic sodium phosphate dodecahydrate, citric acid and sodium hydroxide. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use GLYCONEO 0.5/2.5? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GLYCONEO 0.5/2.5 and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE GLYCONEO 0.5/2.5? GLYCONEO 0.5/2.5 will be given to you by injection by a doctor or a specially trained nurse. Your doctor will know how much GLYCONEO 0.5/2.5 you should be given. The need for more doses will depend on how well your body responds to the treatment. The doctor will decide how many injections you receive, and how often you should receive them More instructions can be found in Section 4. How do I use GLYCONEO 0.5/2.5? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GLYCONEO 0.5/2.5? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist, or any healthcare professional you visit that you are using GLYCONEO 0.5/2.5. THINGS YOU SHOULD NOT DO • Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION –GLYCONEO 0.5 /2.5 (GLYCOPYRRONIUM BROMIDE AND NEOSTIGMINE METHYLSULFATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Glycopyrronium bromide [glycopyrrolate] and neostigmine methylsulfate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of solution for injection contains 500 micrograms (0.5 mg) of glycopyrronium bromide (glycopyrrolate) and 2.5 mg of neostigmine methylsulfate. Excipients with known effect: Each 1 mL contains 3 mg (0.13 mmol) sodium. For the full list of excipients, see Section 6.1 List of excipients. The solution is preservative free and sulfite free. 3 PHARMACEUTICAL FORM Clear, colourless sterile solution for injection free of any visible particles or fibres intended for parenteral intravenous administration 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Reversal of residual non-depolarising (competitive) neuromuscular block. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage This fixed-dose combination product contains a 0.5 mg:2.5 mg/1 mL of glycopyrronium bromide (glycopyrrolate): neostigmine in a fixed 1:5 ratio. If other ratios of these agents are required, these should be prepared using available monotherapy products. _Adults:_ 0.2 mg glycopyrronium bromide (glycopyrrolate) per 1 mg neostigmine intravenously. Alternatively, a dose of 0.016 mL/kg intravenously, equivalent to 0.008 mg/kg glycopyrronium bromide (glycopyrrolate) with 0.04 mg/kg neostigmine. _Children (1 month to 12 years):_ 0.016 mL/kg intravenously, equivalent to glycopyrronium bromide (glycopyrrolate) 0.008 mg/kg and neostigmine 0.04 mg/kg. Total doses in excess of 2 mL are not recommended as this dose of neostigmine may produce depolarising neuromuscular block. 2 Method of administration This medicine is for intravenous administration. It contains no antimicrobial preservative and is for use in one patient on one occasion only. Discard any residue. GLYCONEO 0.5 /2.5 should be administered when the first twitch response is substantially greater than 10 % of baseline, or when a second Lire le document complet