দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
glycopyrronium bromide, Quantity: 0.2 mg/mL
Accord Healthcare Pty Ltd
glycopyrronium bromide (glycopyrrolate)
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride
Intramuscular, Intravenous
10 x 1 mL, 5 x 1 mL
(S4) Prescription Only Medicine
1. As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents.,2. As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra- operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.,3. To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.
Visual Identification: A clear, colourless solution practically free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-06-06
Version 4.0 Page 1 of 3 GLYCOPYRROLATE ACCORD INJECTION _Glycopyrronium bromide (glycopyrrolate), solution for injection, 0.2 mg/1 mL and 0.6 mg/3 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Glycopyrrolate Accord. It does not contain all the available information It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Glycopyrrolate Accord against the benefits they expect it will 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. WHAT GLYCOPYRROLATE ACCORD INJECTION IS USED FOR _WHEN YOU MUST NOT BE _ _GIVEN IT _ Do not have Glycopyrrolate Accord if: You are allergic to Glycopyrrolate Accord or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include rash, itching, hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing. You are breastfeeding or plan to breastfeed. Medicines like Glycopyrrolate Accord may reduce your milk supply. It is not known if Glycopyrrolate Accord is found in breast milk. Do not have Glycopyrrolate Accord if the packaging is torn or shows signs of tampering. Do not have Glycopyrrolate Accord after the expiry date (EXP.) printed on the pack. If you have it after the expiry date has passed, it may not work as well. _BEFORE YOU ARE GIVEN IT _ YOU MUST TELL YOUR DOCTOR IF: 1. YOU HAVE ANY ALLERGIES TO: • any other medicines • any other substances, such as foods, preservatives or dyes 2. YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT. Your doctor will discuss the risks and benefits of receiving Glycopyrrolate Accord during pregnancy. 3. YOU HAVE OR HAVE HAD ANY OTHER MEDICAL CONDITIONS INCLUDING: • asthma • glaucoma, which is an increased pressure in your eyes • diarrhoea • proble সম্পূর্ণ নথি পড়ুন
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION GLYCOPYRROLATE ACCORD (GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE)) INJECTION 1 NAME OF THE MEDICINE Glycopyrronium bromide (glycopyrrolate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL contains 0.2 mg glycopyrronium bromide (glycopyrrolate). 1 ampoule of 1 mL solution for injection contains 0.2 mg glycopyrronium bromide (glycopyrrolate). 1 ampoule of 3 mL solution for injection contains 0.6 mg glycopyrronium bromide (glycopyrrolate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Glycopyrrolate Accord is supplied as a clear, colourless sterile solution for injection, practically free from visible particles, with a pH of 2.0 - 3.0. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Glycopyrrolate Accord is indicated for: • As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents. • As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes. • To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants. 4.2 D OSE AND METHOD OF ADMINISTRATION For intramuscular or intravenous administration. Glycopyrrolate Accord contains no antimicrobial preservative and is for single use in one patient on one occasion only. Discard any remaining residue. PRE-ANAESTHETIC USE _ADULTS _ 0.2 mg to 0.4 mg intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg may be used. Larger doses may result in profound and prolonged antisialogogue effect, which may be unpleasant for the patient. _CHILDREN _ (see SECTION 4.3 CONTRAINDICATIONS ) 1 month to 12 years of age 0.0 সম্পূর্ণ নথি পড়ুন