VENTIMAX CFC FREE INHALER

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

Biotech Laboratories (Pty) Ltd

Dos:

See ingredients

Läkemedelsform:

INHALER

Sammansättning:

EACH METERED DOSE CONTAINS SALBUTAMOL 100,0 ug

Bemyndigande status:

Registered

Tillstånd datum:

2014-05-06

Bipacksedel

BIOTECH LABORATORIES (PTY) LTD.
Currently Approved Patient Information
Leaflet
Ventimax CFC Free (36/10.2.1/0393)
Each metered dose contains salbutamol sulphate equivalent
to 100 µg salbutamol.
21-12-2021
1.3.2 Currently Approved Patient Information Leaflet
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S2
VENTIMAX CFC FREE 100 ΜG METERED DOSE INHALER.
SALBUTAMOL SULPHATE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
VENTIMAX CFC FREE is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless you still need to use VENTIMAX CFC FREE carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share VENTIMAX CFC FREE with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1. What VENTIMAX CFC FREE is and what it is used for
2. What you need to know before you use VENTIMAX CFC FREE
3. How to use VENTIMAX CFC FREE
4. Possible side effects
5. How to store VENTIMAX CFC FREE
6. Contents of the pack and other information
1. WHAT VENTIMAX CFC FREE IS AND WHAT IT IS USED FOR
BIOTECH LABORATORIES (PTY) LTD.
Currently Approved Patient Information
Leaflet
Ventimax CFC Free (36/10.2.1/0393)
Each metered dose contains salbutamol sulphate equivalent
to 100 µg salbutamol.
21-12-2021
1.3.2 Currently Approved Patient Information Leaflet
Page 2 of 9
Active ingredient in VENTIMAX CFC FREE is Salbutamol sulphate.
Each metered dose VENTIMAX CFC FREE contains salbutamol sulphate
equivalent to 100 µg salbutamol.
VENTIMAX CFC FREE inhaler is used for the treatment of bronchospasm,
such as (inflammatory disease of the
airways) asthma and chronic bronchitis or emphysema.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VENTIMAX CFC FREE
DO NOT USE VENTIMAX CFC FREE:
-
if you are hypersensitive (allergic) to salbutamol or any of the other
ingredients of VENTIMAX CFC
FREE

Produktens egenskaper

BIOTECH LABORATORIES (PTY) LTD.
Current Approved Professional Information
Ventimax CFC Free
(36/10.2.1/0393)
Each metered dose contains salbutamol sulphate
equivalent to 100 µg salbutamol.
21-12-2021
1.3.1.1 Approved Professional Information
Page 1 of 10
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
VENTIMAX CFC FREE 100 ΜG METERED DOSE INHALER
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose VENTIMAX CFC FREE contains salbutamol sulphate
equivalent to 100 µg salbutamol.
_ _
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Metered dose inhaler
A metered aerosol inhaler, delivering 100 µg of salbutamol per
inhalation in a standard pale blue polypropylene
actuator with a dark blue polypropylene cap. Each canister provides
200 inhalations.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
VENTIMAX CFC FREE is indicated for use in the treatment of
bronchospasm, asthma and chronic obstructive
pulmonary disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
VENTIMAX CFC FREE is administered by the inhaled route only.
BIOTECH LABORATORIES (PTY) LTD.
Current Approved Professional Information
Ventimax CFC Free
(36/10.2.1/0393)
Each metered dose contains salbutamol sulphate
equivalent to 100 µg salbutamol.
21-12-2021
1.3.1.1 Approved Professional Information
Page 2 of 10
Increasing use of VENTIMAX CFC FREE may be a sign of worsening asthma.
Under these conditions, a
reassessment of the patient’s therapy plan may be required and
concomitant glucocorticosteroid therapy should
be considered.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of administration
should only be increased on medical advice.
One or two inhalations repeated four-hourly if required. The
bronchodilator effect of each administration of
VENTIMAX CFC FREE lasts for at least four hours and more frequent use
should be unnecessary. The patient
can readily recognise any reduction in the length of action and should
be instructed to consult a doctor if the effect
of a previously a