Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
AZTREONAM
GILEAD SCIENCES ISRAEL LTD
J01DF01
LYOPHILIZED POWDER FOR NEBULISER SOLUTION
AZTREONAM 75 MG/VIAL
INHALATION
Required
GILEAD SCIENCES IRELAND UC, IRELAND
AZTREONAM
Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
2019-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon physician’s prescription only CAYSTON ® Powder and solvent for nebuliser solution ACTIVE INGREDIENTS - each vial contains Aztreonam 75mg Inactive ingredients and allergens: See section 6 “_Additional information_”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains summary information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for treating your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. The medicine is not intended for children under the age of 6 years. 1. WHAT IS CAYSTON INTENDED FOR? Cayston is used to suppress chronic lung infection caused by the bacteria _Pseudomonas aeruginosa_ in patients aged 6 years and older with cystic fibrosis. THERAPEUTIC GROUP: antibiotic. Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system. Cystic fibrosis in the lungs leads to clogging them with thick sticky mucus. This makes it hard to breathe. 2. BEFORE TAKING CAYSTON .X. DO NOT USE THIS MEDICINE IF: • You are sensitive ( allergic) to the active ingredient or to any of the other ingredients that this medicine contains (see section 6). .!. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE USING CAYSTON, TELL YOUR PHYSICIAN IF: • you are ALLERGIC TO ANY OTHER ANTIBIOTICS (such as penicillins, cephalosporins, and/or carbapenems). • you do not tolerate or have chest tightness from taking other inhaled medicines. • you have KIDNEY PROBLEMS. • you have ever COUGHED UP ANY BLOOD. • you have ever had LOW LUNG FUNCTION TESTS. If any of these apply to you TELL YOUR DOCTOR before using Cayston. As an inhaled medicine, Cayston could cau Lesen Sie das vollständige Dokument
1 The format of this leaflet was defined by the Ministry of Health and its content was checked and approved by the Ministry of Health in March 2014 and updated according to the guidelines of the Ministry of Health in November 2019. Cayston ® 1. NAME OF THE MEDICINAL PRODUCT Cayston ® . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains aztreonam lysine equivalent to 75 mg aztreonam. After reconstitution the nebuliser solution contains 75 mg aztreonam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for nebuliser solution. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to _Pseudomonas _ _aeruginosa_ in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients should use a bronchodilator before each dose of Cayston. Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 1. bronchodilator 2. mucolytics 3. and lastly, Cayston. _Adults and children 6 years and older _ The recommended dose for adults is 75 mg three times per 24 hours for 28 days. Doses should be taken at least 4 hours apart. Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy. 2 The dosing in children aged 6 years and older is the same as for adults. _Elderly _ Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients. If Cayston is to be prescribed to the elderly then the posology is the same as for adults. _Renal impairment _ Aztreonam is known to Lesen Sie das vollständige Dokument