Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
BUDESONIDE
NOVARTIS ISRAEL LTD
R03BA02
CAPSULES
BUDESONIDE 200 MCG
INHALATION
Required
PHARMACHEMIE B.V., THE NETHERLANDS
BUDESONIDE
BUDESONIDE
Maintenance treatment of bronchial asthma.
2012-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only MIFLONIDE ® MIFLONIDE ® POWDER FOR INHALATION POWDER FOR INHALATION 200 MCG/CAPSULE 400 MCG/CAPSULE CAPSULES CAPSULES THE ACTIVE INGREDIENT: THE ACTIVE INGREDIENT: Each capsule contains: Each capsule contains: Budesonide 200 mcg Budesonide 400 mcg Each 200 mcg capsule contains 230 mcg budesonide and releases 200 mcg budesonide when used with an Aerolizer inhaler. Each 400 mcg capsule contains 460 mcg budesonide and releases 400 mcg budesonide when used with an Aerolizer inhaler. INACTIVE INGREDIENTS: See section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information”. READ THE LEAFLET 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 to treat 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? Maintenance treatment for pulmonary asthma. THERAPEUTIC GROUP: Glucocorticoids. The medicine Miflonide is provided as a capsule. The capsule is to be put in an inhaler called Aerolizer. The inhaler opens the capsule and releases a dry powder that is delivered to the lungs by breathing in. Miflonide contains an active ingredient called budesonide; this substance belongs to a group of medicines called corticosteroids )glucocorticoids(. The medicine Miflonide is used to prevent asthma attacks and ease breathing problems in adults and children from age 6 and above. Use it regularly every day, even if you feel better, as this medicine will help to prevent future breathing problems. Do not use Miflonide to treat a sudden asthma attack. Use a different inhaler to treat these asthma attacks, such as albuterol or salbutamol. Asthma is caused by inflammati Belgenin tamamını okuyun
MIF API MAR14 CL V7 COR CPO CL REF CDS 040713 די לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ ו ב ץרמ 2014 . MIFLONIDE (BUDESONIDE) 200 or 400 microgram inhalation powder, hard capsules PRESCRIBING INFORMATION Trade name Miflonide ® Powder for Inhalation 200 mcg/capsule Miflonide ® Powder for Inhalation 400 mcg/capsule 1 DESCRIPTION AND COMPOSITION Powder for inhalation in capsules to be used in combination with the Aerolizer ® . Each capsule contains the equivalent of either 200 micrograms or 400 micrograms of budesonide. PHARMACEUTICAL FORM(S) Inhalation powder, hard capsule_. _ The 200 microgram capsule has a pink opaque cap and a colourless transparent body, printed / BUDE 200. The 400 microgram capsule has a pink opaque cap and a colourless transparent body, printed with / BUDE 400. ACTIVE SUBSTANCE Budesonide EXCIPIENTS Lactose monohydrate (which contains milk proteins): Each Capsule of Miflonide ® Powder for Inhalation 200 mcg/capsule contains 24.77mg lactose monohydtare. Each Capsule of Miflonide ® Powder for Inhalation 400 mcg/capsule contains 24.54mg lactose monohydtare. Page 2 MIF API MAR14 CL V7 COR CPO CL REF CDS 040713 2 INDICATIONS Maintenance treatment of bronchial asthma. 3 DOSAGE AND ADMINISTRATION DOSAGE The dosage should be adjusted individually to the lowest dose required for maintenance therapy. Budesonide should be taken regularly every day. The dose should be retitrated individually when transferring a patient from one inhalation device to another,. In order to reduce the risk of candida infection it is recommended to rinse the mouth well with water and subsequently spit out the rinsing water after each administration (see section 6 Warnings and precautions and section 7 Adverse drug reactions). Rinsing the mouth may also help to prevent throat irritation and reduce the risk of systemic effects. The lowest dosage in a single capsule is 200 micrograms. If a single dose of less than 200 micrograms is required, t Belgenin tamamını okuyun