País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
acetylcholine chloride, Quantity: 10 mg/mL
Bausch & Lomb Australia Pty Ltd
Acetylcholine chloride,Mannitol
Diluent, not applicable
Excipient Ingredients: sodium acetate; magnesium chloride hexahydrate; potassium chloride; calcium chloride dihydrate; water for injections
Intraocular
12 x 20mg/2mL vials with diluent ampoules, 1 x 20mg/2mL vial with diluent ampoule
(S4) Prescription Only Medicine
Miochol-E is used to obtain complete miosis of the iris in seconds after placement of the intraocular lens (IOL) in cataract surgery; and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.
Visual Identification: Clear colourless solution in glass ampoule; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-08-31
MIOCHOL ® -E _acetylcholine chloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Miochol-E. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risk of you being given Miochol- E against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN MIOCHOL-E, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MIOCHOL-E IS USED FOR Miochol-E is used to constrict the pupil of the eye during cataract surgery and other types of eye surgery. It belongs to a group of medicines called parasympathomimetics. It works by mediating nerve impulse transmission. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children. BEFORE YOU ARE GIVEN MIOCHOL-E _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN MIOCHOL-E IF YOU HAVE AN ALLERGY TO: • any medicine containing acetylcholine chloride • any of the ingredients listed at the end of this leaflet. 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. YOU MUST NOT BE GIVEN MIOCHOL-E AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING I Leia o documento completo
Miochol-E PI-A-20200921 v4 Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION – MIOCHOL-E (ACETYLCHOLINE CHLORIDE) POWDER FOR SOLUTION FOR INTRAOCULAR IRRIGATION 1 NAME OF THE MEDICINE Acetylcholine chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains acetylcholine chloride 20 mg as the active ingredient. Miochol-E contains acetylcholine chloride 10 mg/mL upon reconstitution with the 2 mL of diluent in the ampoule. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for solution for irrigation and diluent. Powder: white solid or powder in clear glass vials. Diluent: clear colourless solution in glass ampoules. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Miochol-E is used to obtain complete miosis of the iris in seconds after placement of the intraocular lens (IOL) in cataract surgery and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required. 4.2 D OSE AND METHOD OF ADMINISTRATION In most cases 0.5 to 2 mL produces satisfactory miosis. The syringe containing the reconstituted preparation must be fitted with a suitable irrigation cannula for intraocular irrigation. The Miochol-E solution is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border. If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis, Miochol-E PI-A-20200921 v4 Page 2 of 7 such as anterior or posterior synechiae, must be released to permit the desired effect of the drug. The solution should be reconstituted immediately before use since aqueous solutions of acetylcholine are unstable. INSTRUCTIONS FOR USE AND HANDLING Warning: Do not use if blister or peelable backing is damaged or broken. Open under aseptic conditions only, at the time of surgery. DIRECTIONS FOR PREPAR Leia o documento completo