VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION INJECTION

Ülke: Güney Afrika

Dil: İngilizce

Kaynak: South African Health Products Regulatory Authority (SAHPRA)

Mevcut itibaren:

GlaxoSmithKline South Africa (Pty) Limited

Doz:

See ingredients

Farmasötik formu:

INJECTION

Kompozisyon:

EACH I ml CONTAINS SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 1,0 mg

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1976-07-04

Bilgilendirme broşürü

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
TD
Submission Date
04 Dec 2020
Type
CGC
V
ENTOLIN
I
NJECTION
Implementation Date
TBA
Category
C.I.0.1 (Type 1A
IN
)
0,5
MG
/
ML SALBUTAMOL
Approval Date
TBA
Reference
GDS20-21-
v0001
CONFIDENTIAL
1.3.2
PATIENT INFORMATION LEAFLET
Page
1
of
9
GDS-20 + 21
4/12/2020
VENTOLIN INJECTION
1
PATIENT INFORMATION LEAFLET
2
(COMPLIANT)
3
4
SCHEDULING STATUS:
5
S4
6
7
VENTOLIN INJECTION
8
Salbutamol 0,5 mg/ml
9
10
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING VENTOLIN
INJECTION.
11
-
Keep this leaflet. You may need to read it again.
12
-
If you have further questions, please ask your doctor, nurse or
pharmacist.
13
-
VENTOLIN INJECTION has been prescribed for you and you should not pass
it on to
14
others. It may harm them, even if their symptoms are the same as
yours.
15
16
WHAT IS IN THIS LEAFLET:
17
1. What VENTOLIN INJECTION is and what it is used for
18
2. What you need to know before you are given VENTOLIN INJECTION
19
3. How VENTOLIN INJECTION is administered
20
4. Possible side effects
21
5. How to store VENTOLIN INJECTION
22
6. Contents of the pack and other information.
23
24
25
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
TD
Submission Date
04 Dec 2020
Type
CGC
V
ENTOLIN
I
NJECTION
Implementation Date
TBA
Category
C.I.0.1 (Type 1A
IN
)
0,5
MG
/
ML SALBUTAMOL
Approval Date
TBA
Reference
GDS20-21-
v0001
CONFIDENTIAL
1.3.2
PATIENT INFORMATION LEAFLET
Page
2
of
9
GDS-20 + 21
4/12/2020
1. WHAT VENTOLIN INJECTION IS AND WHAT IT IS USED FOR:
26
Salbutamol is one of a group of medicines called beta-2-agonists which
act on special receptor
27
sites in the body.
28
VENTOLIN INJECTION can be used for two different purposes.
29
i.
To relieve severe bronchospasm (wheeze as in asthma and chronic
bronchitis).
30
ii.
To stop premature labour.
31
32
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VENTOLIN INJECTION:
33
YOU SHOULD NOT BE GIVEN VENTOLIN INJECTION:
34
•
if you are hypersensitive (allergic) to salbutamol sulphate or the
other ingredients of
35
VENTOLIN INJ

Ürün özellikleri

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
TD
Submission Date
04 Dec 2020
Type
CGC
V
ENTOLIN
I
NJECTION
Implementation Date
TBA
Category
C.I.0.1 (Type 1A
IN
)
0,5
MG
/
ML SALBUTAMOL
Approval Date
TBA
Reference
GDS20-21-
v0001
CONFIDENTIAL
1.3
SOUTH AFRICAN LABELLING AND PACKAGING
1.3.1
SOUTH AFRICAN PROFESSIONAL INFORMATION
1.3.1.1
PROFESSIONAL INFORMATION
Page 1 of 11
GDS-21
4/12/20202
VENTOLIN INJECTION
1
PROPOSED PI (CLEAN)
2
3
4
SCHEDULING STATUS:
5
S4
6
7
1.
NAME OF THE MEDICINE:
8
VENTOLIN INJECTION
9
Salbutamol 0,5 mg/ml
10
11
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
12
Ampoules of 1 ml each of which contains salbutamol sulphate B.P.
equivalent to 0,5 mg
13
(500 µg) salbutamol.
14
For full list of excipients, see section 6.1.
15
16
3. PHARMACEUTICAL FORM:
17
Injection.
18
The solution is colourless to very pale straw coloured and odourless.
Its specific gravity and
19
viscosity are similar to water.
20
21
4. CLINICAL PARTICULARS:
22
4.1 THERAPEUTIC INDICATIONS:
23
1. Use in Asthma:
24
VENTOLIN INJECTION is indicated for the relief of severe bronchospasm
associated with
25
asthma or bronchitis and for the treatment of status asthmaticus.
26
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
TD
Submission Date
04 Dec 2020
Type
CGC
V
ENTOLIN
I
NJECTION
Implementation Date
TBA
Category
C.I.0.1 (Type 1A
IN
)
0,5
MG
/
ML SALBUTAMOL
Approval Date
TBA
Reference
GDS20-21-
v0001
CONFIDENTIAL
1.3
SOUTH AFRICAN LABELLING AND PACKAGING
1.3.1
SOUTH AFRICAN PROFESSIONAL INFORMATION
1.3.1.1
PROFESSIONAL INFORMATION
Page 2 of 11
GDS-21
4/12/20202
2. Use in Obstetrics:
27
VENTOLIN INJECTION is indicated to inhibit uncomplicated premature
labour between 22
28
and 37 weeks of gestation in patients with no medical or obstetric
contra-indication to
29
tocolytic therapy.
30
31
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
32
VENTOLIN INJECTION is to be used only under medical direction.
33
VENTOLIN INJECTION should not be administered in the same syringe as
any other
34
medication.
35
36
1. USE IN ASTHMA:
37
VENTOLIN
INJECTION
m