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סימביקורט טורבוהלר 320/9 מק"ג/מנה SYMBICORT TURBUHALER 320/9 MCG/DOSE (BUDESONIDE MICRONIZED, FORMOTEROL FUMARATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

שאיפה : INHALATION

צורת מינון:

אבקה לשאיפה : POWDER FOR INHALATION

Posology : מינונים

4.2 Posology and method of administration
Route of administration: For inhalation use



Posology
Asthma
Symbicort Turbohaler 320/9 mcg/dose is not intended for the initial management of asthma. The dosage of the components of Symbicort Turbuhaler 320/9 mcg/dose is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated, but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor-agonists and/or corticosteroids by individual inhalers should be prescribed.


Recommended doses:
Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily.
Adolescents (12-17 years): 1 inhalation twice daily.


Patients should be regularly reassessed by their prescriber/health care provider, so that the dosage of Symbicort Turbuhaler 320/9 mcg/dose remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.


In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Symbicort Turbuhaler 320/9 mcg/dose given once daily, when in the opinion of the prescriber, a long acting bronchodilator would be required to maintain control.


Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.


Children (6 years and older): A lower strength (80 micrograms/4.5 micrograms/inhalation) is available for children 6-11 years.


Children under 6 years: As only limited data are available, Symbicort Turbuhaler 320/9 mcg/dose is not recommended for children younger than 6 years.


Symbicort Turbuhaler 320/9 micrograms/dose should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen (160 micrograms/4.5 micrograms/inhalation and 80 micrograms/4.5 micrograms/inhalation).


COPD
Recommended doses:
Adults: 1 inhalation twice daily.

General information
Special patient groups: There are no special dosing requirements for elderly patients.
There are no data available for use of Symbicort Turbuhaler 320/9 mcg/dose in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.


Method of Administration
Instructions for correct use of Symbicort Turbohaler 320/9 mcg/dose: The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient:
-   To carefully read the instructions for use in the patient information leaflet which is packed together with each Symbicort Turbohaler 320/9 mcg/dose inhaler -   To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs
-   Never to breathe out through the mouthpiece
-   To replace the cover of the Symbicort Turbuhaler 320/9 mcg/dose Inhaler after use.
-   To rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.


The patient may not taste or feel any medication when using Symbicort Turbuhaler 320/9 mcg/dose due to the small amount of drug dispensed.


מסגרת הכללה בסל

התוויות הכלולות במסגרת הסל

התוויה תאריך הכללה תחום קליני Class Effect מצב מחלה
COPD
אסטמה
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/01/2009
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

בעל רישום

ASTRAZENECA (ISRAEL) LTD

רישום

130 94 30921 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

21.07.21 - עלון לרופא

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לתרופה במאגר משרד הבריאות

סימביקורט טורבוהלר 320/9 מק"ג/מנה

קישורים נוספים

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