BUDICORT RESPULES 1 MG2ML

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

BUDESONIDE

MAH:

ASTRAZENECA (ISRAEL) LTD

ATC_code:

R03BA02

pharmaceutical_form:

SUSPENSION FOR INHALATION

composition:

BUDESONIDE 0.5 MG/ML

administration_route:

INHALATION WITH NEBULISER

prescription_type:

Required

manufactured_by:

ASTRA ZENECA AB., SWEDEN

therapeutic_group:

BUDESONIDE

therapeutic_area:

BUDESONIDE

therapeutic_indication:

Bronchial asthma, especially in cases where other therapy is insufficient or unsuitable.

authorization_date:

2023-11-30

PIL

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

SPC

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