מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Budesonide 3mg
Te Arai BioFarma Limited
3 mg
Modified release capsule
Active: Budesonide 3mg Excipient: Gelatin Ethylcellulose dispersion Type B Ink black 10A2 Iron oxide black Iron oxide red Methacrylic acid copolymer Polysorbate 80 Purified talc Sugar spheres Titanium dioxide Triethyl citrate
Prescription
Indicated for the induction of remission in patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with cap containing desiccant in outer carton - 20 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 45 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 90 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
2022-02-04
New Zealand Consumer Medicine Information BUDESONIDE TE ARAI _BUDESONIDE _ 3 mg, Controlled-Release Capsules WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Budesonide Te Arai. This leaflet answers some common questions about Budesonide Te Arai. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Budesonide Te Arai against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT BUDESONIDE TE ARAI IS USED FOR Budesonide is used to treat Crohn’s disease. It can be used to treat acute attacks. Crohn’s disease is an inflammatory disease of the bowel. It mainly affects the small bowel and the first part of the large bowel and causes symptoms such as stomach pain, diarrhoea and fever. Budesonide Te Arai contains budesonide. It belongs to the group of medicines called corticosteroids, which are used to help reduce inflammation in many parts of the body. Budesonide capsules are designed to release their contents gradually in the last part of the small bowel (the ileum) and the first part of the large bowel. Ask your doctor if you have any questions about why budesonide has been prescribed for you. Your doctor may have prescribed budesonide for another reason. 1 Ask your doctor if you have any questions about why budesonide has been prescribed for you. This medicine is available only with a doctor's prescription. This medicine is not addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU USE BUDESONIDE TE ARAI _ _ _ _ _WHEN YOU MUST NOT USE IT _ Do not use budesonide if you have an allergy to: • any medicine containing budesonide • any ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may קרא את המסמך השלם
Budesonide Te Arai Data Sheet v 3.0 July 2023 Page 1 of 8 1 PRODUCT NAME Budesonide Te Arai 3 mg controlled-release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 3 mg of budesonide. Excipient(s) with known effect • Each 3mg capsule contains approximately 285 mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Number 1 gelatin capsules, light grey opaque body and swedish orange opaque cap. Each capsule contains budesonide 3 mg as gastro-resistant, prolonged release pellets. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Indicated for the induction of remission in patients with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon. 4.2 Dose and method of administration The capsules should be swallowed whole with water. For patients with difficulty swallowing, the capsules may be opened, and the contents swallowed after mixing with a tablespoon of apple sauce. It is important that the contents of the capsules are not crushed or chewed. Adults The recommended daily dose for induction of remission is 9 mg, administered once daily for up to eight weeks. The dose should be taken in the morning before breakfast. Full effect is usually achieved within 2-4 weeks. When treatment with budesonide capsules is to be discontinued, the dose should be tapered for 2 to 4 weeks and not stopped abruptly. Children There are limited data on the use of budesonide capsules in children. The available data are insufficient to support safety and efficacy in the paediatric population, therefore such use cannot be recommended until further data become available. Influence on Growth It is recommended that the height of children receiving prolonged treatment with corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated. The benefits of corticosteroid therapy and the possible risk of growth suppression must be carefully weighed. Long- term studies have not been performed in children treated with budesonide capsules. קרא את המסמך השלם