PCV-10 CIPLA INJECTION

Country: Afrika Selatan

Bahasa: Inggeris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Boleh didapati daripada:

Cipla Medpro (Pty) Ltd

Dos:

Not Indicated

Borang farmaseutikal:

INJECTION

Komposisi:

None

Status kebenaran:

Registered

Risalah maklumat

_Cipla Mepdro (Pty) Ltd _
_ _
_PCV-10 Cipla suspension for injection _
_1.3.2 _
_Version 2.0 (Dec 2021) _
_Page 1 of 8 _
_ _
_ _
_ _
MODULE 1.3.2.
PATIENT INFORMATION LEAFLET FOR PCV-10 CIPLA
SCHEDULING STATUS:
S2
PCV-10 CIPLA Suspension for injection
Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING PCV-10 CIPLA:
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
WHAT IS IN THIS LEAFLET
1. What PCV-10 CIPLA is and what it is used for.
2. What you need to know before you use PCV-10 CIPLA.
3. How to use PCV-10 CIPLA.
4. Possible side effects.
5. How to store PCV-10 CIPLA.
6. Contents of the pack and other information.
1. WHAT PCV-10 CIPLA IS AND WHAT IT IS USED FOR:
PCV-10 CIPLA is a vaccine that contains ten polysaccharide serotypes
from the bacterium,
_Streptococcus pneumoniae_, as antigens or active substances of the
medicine.
I.Arbee
_Cipla Mepdro (Pty) Ltd _
_PCV-10 Cipla suspension for injection _
_1.3.2 _
_Version 2.0 (Dec 2021) _
_Page 2 of 8 _
PCV-10 CIPLA is used to immunise (or in the prevention of) children,
aged 6 weeks to 24
months, against diseases caused by _Streptococcus pneumoniae_, which
include meningitis
(inflammation around the brain), sepsis or bacteraemia (bacteria in
the blood stream),
pneumonia (lung infection) and ear infections.
PCV-10 CIPLA is used to immunise children aged up to 2 years old
against diseases caused by
_S. pneumoniae_, which include meningitis (inflammation around the
brain), sepsis or
bacteraemia (bacteria in the blood stream), pneumonia (lung infection)
and ear infections.
2.
WHAT YOU NEED TO KNOW BEFORE USE PCV-10 CIPLA:
PCV-10 CIPLA SHOULD NOT BE GIVEN TO YOU OR YOUR CHILD IF THE FOLLOWING
APPLIES TO YOU OR
YOUR CHILD:
•
Allergic to the active substances or to any of the other ingredients
in this medicine (listed
in SECTION 6.1) or to any other vaccine that contains diphtheria
to

Ciri produk

Cipla Medpro (Pty) Ltd.
PCV-10 CIPLA suspension for injection
1.3.1.1
Version 2.0 (Dec 2021)
Page 1 of 13
MODULE 1.3.1.1
PROPOSED PROFESSIONAL INFORMATION FOR PCV-10 CIPLA
1
2
SCHEDULING STATUS
3
4
5
1.
NAME OF MEDICINE
6
PCV-10 CIPLA Suspension for injection
7
Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)
8
9
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10
Each 0,5 mL (1 dose) suspension for injection contains:
11
Pneumococcal polysaccharide serotype 1:
2 mcg;
12
Pneumococcal polysaccharide serotype 5:
2 mcg;
13
Pneumococcal polysaccharide serotype 6A: 2 mcg;
14
Pneumococcal polysaccharide serotype 6B: 4 mcg
)
;
15
Pneumococcal polysaccharide serotype 7F: 2 mcg;
16
Pneumococcal polysaccharide serotype 9V: 2 mcg;
17
Pneumococcal polysaccharide serotype 14: 2 mcg;
18
Pneumococcal polysaccharide serotype 19A: 2 mcg;
19
Pneumococcal polysaccharide serotype 19F: 2 mcg; and
20
Pneumococcal polysaccharide serotype 23F: 2 mcg.
21
Serotypes are conjugated to CRM197-diphtheria carrier protein 19 to 48
mcg, adsorbed on
22
aluminium phosphate. Each 0,5 mL dose contains 0,125 mg aluminium.
Sugar free.
23
24
For the full list of excipients, see SECTION 6.1.
25
S2
I.Arbee
Cipla Medpro (Pty) Ltd.
PCV-10 CIPLA suspension for injection
1.3.1.1
Version 2.0 (Dec 2021)
Page 2 of 13
3.
PHARMACEUTICAL FORM
26
Suspension for injection.
27
PCV-10 CIPLA is a whitish turbid liquid (filled in clear glass vials
closed with rubber closure,
28
aluminum seal and a polypropylene flip-off cap) tends to settle down
on keeping and is free from
29
foreign particles/floccules.
30
31
4.
CLINICAL PARTICULARS
32
4.1.
THERAPEUTIC INDICATIONS
33
Active immunisation against invasive disease, pneumonia and acute
otitis media caused by
34
_Streptococcus pneumoniae_ serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A,
19F and 23F in infants and
35
toddlers from 6 weeks up to 2 years of age.
36
The use of vaccine should be determined on the basis of relevant
recommendations and take
37
into consideration the disease impact by age and regional
epidemi