Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
hyoscine butylbromide, Quantity: 20 mg
Southern XP IP Pty Ltd
Hyoscine butylbromide
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide
Intravenous, Intramuscular
10, 5
(S4) Prescription Only Medicine
Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.
Visual Identification: Clear, colourless or almost colourless solution filled in Type I clear glass ampoules.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-07-12
HYOSCINE BUTYLBROMIDE SXP Hyoscine Butylbromide SXP 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I GIVEN HYOSCINE BUTYLBROMIDE SXP? 2. WHAT SHOULD I KNOW BEFORE I RECEIVE HYOSCINE BUTYLBROMIDE SXP? 3. WHAT IF I AM TAKING OTHER MEDICINES? 4. HOW DO I RECEIVE HYOSCINE BUTYLBROMIDE SXP? 5. WHAT SHOULD I KNOW AFTER BEING GIVEN HYOSCINE BUTYLBROMIDE SXP? 6. ARE THERE ANY SIDE EFFECTS? The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. HYOSCINE BUTYLBROMIDE SXP CONTAINS THE ACTIVE INGREDIENT HYOSCINE BUTYLBROMIDE. Hyoscine butylbromide is an anticholinergic medicine. HYOSCINE BUTYLBROMIDE SXP IS USED TO RELIEVE THE PAIN OF STOMACH AND BOWEL CRAMPS BY HELPING YOUR DIGESTIVE SYSTEM TO RELAX. IT IS ALSO USED TO HELP RELAX GALLBLADDER SPASMS AND KIDNEY SPASMS, AND AS A DIAGNOSTIC AID IN RADIOLOGY. For more information, see Section 1. Why am I given Hyoscine Butylbromide SXP? in the full CMI. Do not use if you have ever had an allergic reaction to hyoscine butylbromide or any of the ingredients listed at the end of the CMI. 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 receive Hyoscine Butylbromide SXP? in the full CMI. Tell your doctor or pharmacist if you are taking or using any other medicines including any that you get without a prescription from your pharmacy, supermarket, or health food shop. Hyoscine Butylbromide SXP must not be given in the muscle if you are being treated with anticoagulant medicines. For more information see Section 3. What if I am taking or using other medicines? in the full CMI. • Your doctor will decide what dose you will receive and the duration of treatment. • Hyoscine Butylbromide SXP is administered by a doctor or nurse. It is given by deep injection into a muscle (e.g. the buttock, upper leg or upper arm) or slow injection into a Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – HYOSCINE BUTYLBROMIDE SXP (HYOSCINE BUTYLBROMIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Hyoscine butylbromide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ampoule containing hyoscine butylbromide 20 mg in 1 mL. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Clear, colourless or almost colourless solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology. 4.2 D OSE AND METHOD OF ADMINISTRATION 1 or 2 ampoules (20 or 40 mg) by intramuscular or slow intravenous injection. A maximum daily dose of 100 mg should not be exceeded. Hyoscine butylbromide ampoules should not be administered on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. Product is for single use in one patient only. Discard any residue 4.3 C ONTRAINDICATIONS Hyoscine butylbromide is contraindicated in patients with: • known hypersensitivity to hyoscine butylbromide or to any excipients of the product (excipients are listed under section 6.1 List of excipients) • mechanical stenoses of the gastrointestinal tract • achalasia • paralytic or obstructive ileus • intestinal atony • prostatic hypertrophy with urinary retention • myasthenia gravis • glaucoma • pathological tachyarrhythmias • megacolon Hyoscine butylbromide should not be given to patients with porphyria as, according to a single report, it has been said to exacerbate the disease. 2 By intramuscular injection, hyoscine butylbromide ampoules are contraindicated in patients being treated with anticoagulant drugs as intramuscular haematoma may occur. In these patients, intravenous routes may be used. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fain Přečtěte si celý dokument