DUORESP SPIROMAX 320 MCG9 MCG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE DIHYDRATE

Beschikbaar vanaf:

ABIC MARKETING LTD, ISRAEL

ATC-code:

R03AK07

farmaceutische vorm:

POWDER FOR INHALATION

Samenstelling:

FORMOTEROL FUMARATE DIHYDRATE 9 MCG/DOSE; BUDESONIDE MICRONIZED 320 MCG/DOSE

Toedieningsweg:

INHALATION

Prescription-type:

Required

Geproduceerd door:

NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS, IRELAND

Therapeutisch gebied:

FORMOTEROL AND BUDESONIDE

therapeutische indicaties:

DuoResp Spiromax 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.Or- Patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.Chronic Obstructive Pulmonary Disease (COPD)DuoResp Spiromax 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in I second (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

Autorisatie datum:

2020-09-30

Bijsluiter

Inhaled steroids can affect the normal production of
steroid hormones in your body, particularly if you use
high doses for a long time. This effect may be manifested
in:
• Changes in bone density )thinning of the bones(
• Cataract )clouding of the lens of the eye(
• Glaucoma )increased intraocular pressure(
• A slowing in the rate of growth of children and
adolescents, requiring monitoring by the attending
doctor, who, if necessary, may refer the child to a
specialist
• An effect on the adrenal gland )a small gland located
next to the kidney(
These effects are more likely to happen with treatment
with oral steroids )such as tablets( than with treatment
with inhaled steroids.
IF A SIDE EFFECT OCCURS, IF ONE OF THE SIDE EFFECTS
WORSENS OR IF YOU SUFFER FROM A SIDE EFFECT NOT
MENTIONED IN THE LEAFLET, CONSULT WITH THE DOCTOR.
Side effects can be reported to the Ministry of Health
by clicking on the link “Report Side Effects of Drug
Treatment” found on the Ministry of Health homepage
)www.health.gov.il( that directs you to the online form for
reporting side effects, or by entering the link:
https://sideeffects.health.gov.il
5. HOW SHOULD THE MEDICINE BE STORED?
• Avoid poisoning! This medicine, and any other
medicine, must be kept in a safe place out of the reach
and sight of children and/or infants in order to avoid
poisoning. Do not induce vomiting unless explicitly
instructed to do so by the doctor.
• Do not use the medicine after the expiry date
)exp. date( that appears on the package. The expiry
date refers to the last day of that month.
• Store below 25°C.
• Keep the mouthpiece closed after removing the
aluminum wrapper.
• Can be used for 6 months after removing the aluminum
wrapper. It is recommended to use the sticker on the
inhaler to record the opening date of the wrapper.
• Do not store different medicines in the same package.
• Discard the inhaler after you have used the last dose,
do not discard it into the household wastebin. Please
consult with your pharmacist on how to dis