Land: Israel
Språk: engelsk
Kilde: Ministry of Health
BUDESONIDE
ASTRAZENECA (ISRAEL) LTD
R03BA02
SUSPENSION FOR INHALATION
BUDESONIDE 0.5 MG/ML
INHALATION WITH NEBULISER
Required
ASTRA ZENECA AB., SWEDEN
BUDESONIDE
BUDESONIDE
Bronchial asthma, especially in cases where other therapy is insufficient or unsuitable.
2023-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY BUDICORT ® RESPULES 0.5 MG/2 ML BUDICORT ® RESPULES 1 MG/2 ML Suspension for Inhalation COMPOSITION BUDICORT ® RESPULES 0.5 MG/2 ML CONTAINS: BUDESONIDE 0.5 MG BUDICORT ® RESPULES 1 MG/2 ML CONTAINS: BUDESONIDE 1.0 MG For inactive ingredients, please see Section 6 – Further Information. READ THE PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of bronchial asthma. THERAPEUTIC GROUP Corticosteroids 2. BEFORE USING THE MEDICINE X Do not use the medicine if: you are sensitive or have had sensitivity to budesonide or to any of the medicine's ingredients (see section 6). ! SPECIAL WARNINGS REGARDING USE OF BUDICORT RESPULES Before treatment with Budicort Respules, tell the doctor if: • you suffer from a lung infection • you have a cold, are suffering from a chest infection • you suffer from liver problems If you experience blurred vision or other visual disturbances please contact your doctor. DRUG INTERACTIONS IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON- PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. Especially inform the doctor or pharmacist if you are taking: • steroidal medicines • medicines for treatment of fungal infections (such as medicines that contain ketoconazole or itraconazole) • medicines for treatment of HIV (such as medicines that contain cobicistat or ritonavir) PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant, breastfeeding, may be pregnant or planning to become pregnant, consult your doctor or read_full_document
1. TRADE NAME OF THE MEDICINAL PRODUCT Budicort® Respules® 1 mg/2ml, nebuliser suspension. Budicort® Respules® 0.5 mg/2ml, nebuliser suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Budicort® Respules® 1 mg/2ml, nebuliser suspension Budicort® Respules® 0.5 mg/2ml, nebuliser suspension. One single dose unit contains 0.5 mg or 1 mg budesonide per 2 ml. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Sterile nebuliser suspension a white to off-white suspension in plastic single dose units 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bronchial asthma especially in cases where other therapy is insufficient or unsuitable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Dosage schedules: Budicort Respules should be administered from suitable nebulisers. The dose delivered to the patient varies depending on the nebulising equipment used. The nebulisation time and the dose delivered is dependent on flow rate, volume of nebuliser chamber and fill volume. An air-flow rate of 6 - 8 litres per minute through the device should be employed. A suitable fill volume for most nebulisers is 2 - 4 ml. The dosage of Budicort Respules should be adjusted to the need of the individual. The dose should be reduced to the minimum needed to maintain good asthma control. The highest dose (2 mg per day) for children under 12 years should only be considered in children with severe asthma and during limited periods. BRONCHIAL ASTHMA Administration can be once or twice daily. Once daily administration can be used for daily doses of 0.25 – 1 mg INITIATION OF THERAPY When treatment is started, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the recommended dose of Budicort Respules is: ADULTS (INCLUDING ELDERLY): Usually 1 – 2 mg total daily dose. In very severe cases the dosage may be increased. Children 12 years and older: Dosage as for adults. CHILDREN 6 MONTHS TO 12 YEARS: 0.25 – 0.5 mg total daily dose. In patients depending on oral glucocorticosteroids, a higher sta read_full_document