Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ipratropium bromide; Salbutamol sulfate
Boehringer Ingelheim Ltd
R03AL02
Ipratropium bromide; Salbutamol sulfate
200microgram/1ml ; 1mg/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010400; GTIN: 5012816000124
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or practice nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What COMBIVENT UDVs is and what it is used for 2. Before you use COMBIVENT UDVs 3. How to use COMBIVENT UDVs 4. Possible side effects 5. How to store COMBIVENT UDVs 6. Further information 1. WHAT COMBIVENT UDVS IS AND WHAT IT IS USED FOR The name of your medicine is COMBIVENT UDVs. You use it with a device called a ‘nebuliser’. This changes your medicine into a mist for you to breathe in. COMBIVENT contains two different medicines called: • Ipratropium bromide and • Salbutamol sulfate Both belong to a group of medicines called bronchodilators. They are used to make breathing easier in an illness called ‘chronic obstructive pulmonary disease’ or COPD. They work by opening up your airways. 2. BEFORE YOU USE COMBIVENT UDVS DO NOT USE COMBIVENT IF: • You are allergic (hypersensitive) to ipratropium or salbutamol or any of the other ingredients in COMBIVENT. (Listed in section 6: Further information) • You are allergic to similar medicines which contain atropine or medicines like atropine • You have a heart problem called ‘hypertrophic obstructive cardiomyopathy’. This is where the wall between the two sides of the heart gets bigger and blocks the blood flow • You have a very fast heart beat (called ‘tachyarrythmia’) • You are pregnant, likely to get pregnant or are breast-feeding Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using COMBIVENT. TAKE SPECIAL CARE WIT Baca dokumen lengkapnya
OBJECT 1 COMBIVENT UDVS Summary of Product Characteristics Updated 29-Jan-2018 | Boehringer Ingelheim Limited 1. Name of the medicinal product Combivent ® UDVs ® 2. Qualitative and quantitative composition Each 2.5 ml single dose unit contains 500 micrograms ipratropium bromide (as 520 micrograms ipratropium bromide monohydrate) and 3 mg salbutamol sulfate (corresponds to 2.5mg salbutamol base). For excipients, see 6.1. 3. Pharmaceutical form Nebuliser solution. A clear, colourless or almost colourless solution. 4. Clinical particulars 4.1 Therapeutic indications The management of bronchospasm in patients suffering from chronic obstructive pulmonary disease who require regular treatment with both ipratropium and salbutamol. 4.2 Posology and method of administration COMBIVENT UDVs are intended for inhalation only and may be administered from a suitable nebuliser or an intermittent positive pressure ventilator. The single dose units must not be taken orally or administered parenterally. Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician. The treatment with the nebuliser solution in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases two unit dose vials may be required for symptom relief. Administration should be stopped when sufficient symptom relief is achieved. The recommended dose is: _Adults (including elderly patients and children over 12 years):_ 1 single dose unit three or four times daily. _Children under 12 years:_ There is no experience of the use of COMBIVENT UDVs in children under 12 years. Administration: Please refer to the patient information leaflet for instructions for use with a nebuliser. Since the single dose units contain no preser Baca dokumen lengkapnya