Shingrix
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
05-12-2023
Karatteristiċi tal-prodott
(SPC)
05-12-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-09-2020
Ingredjent attiv:
Recombinant varicella zoster virus glycoprotein E
Disponibbli minn:
GlaxoSmithkline Biologicals SA
Kodiċi ATC:
J07BK03
INN (Isem Internazzjonali):
herpes zoster vaccine (recombinant, adjuvanted)
Grupp terapewtiku:
Vaccines
Żona terapewtika:
Herpes Zoster
Indikazzjonijiet terapewtiċi:
Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of HZ.The use of Shingrix should be in accordance with official recommendations.
Sommarju tal-prodott:
Revision: 9
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-03-21
Fuljett ta 'informazzjoni
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
Herpes zoster vaccine (recombinant, adjuvanted)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Shingrix is and what it is used for
2.
What you need to know before you receive Shingrix
3.
How Shingrix is given
4.
Possible side effects
5.
How to store Shingrix
6.
Contents of the pack and other information
1.
WHAT SHINGRIX IS AND WHAT IT IS USED FOR
WHAT SHINGRIX IS USED FOR
Shingrix is a vaccine that helps to protect adults against shingles
(herpes zoster) and post-herpetic
neuralgia (PHN), the long-lasting nerve pain that follows shingles.
Shingrix is given to:
•
adults 50 years and above;
•
adults 18 years and above who are at increased risk of shingles.
Shingrix cannot be used to prevent chickenpox (varicella).
WHAT SHINGLES IS
•
Shingles is a rash with blisters that is often painful. It usually
occurs in one part of the body and
can last for several weeks.
•
Shingles is caused by the same virus that causes chickenpox.
•
After you have had chickenpox, the virus that caused it stays in your
body in nerve cells.
•
Sometimes, after many years, if your immune system (the body’s
natural defences) becomes
weaker (due to age, an illness or a medicine you are taking), the
virus can cause shingles.
COMPLICATIONS RELATED TO SHINGLES
Shingles may lead to complications.
The most common complication of shingles is:
•
long-lasting nerve pain – called post-herpetic neuralgia or PHN.
After the shingles blisters heal,
you may get pain which can
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Shingrix powder and suspension for suspension for injection
Herpes zoster vaccine (recombinant, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus
1
glycoprotein E antigen
2,3
50 micrograms
1
Varicella Zoster Virus = VZV
2
adjuvanted with AS01
B
containing:
plant extract
_Quillaja saponaria_
Molina, fraction 21 (QS-21)
50 micrograms
3-O-desacyl-4’-monophosphoryl lipid A (MPL) from
_Salmonella minnesota_
50 micrograms
3
glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA
technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The powder is white.
The suspension is an opalescent, colourless to pale brownish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Shingrix is indicated for prevention of herpes zoster (HZ) and
post-herpetic neuralgia (PHN), in:
•
adults 50 years of age or older;
•
adults 18 years of age or older at increased risk of HZ
_. _
_ _
The use of Shingrix should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The primary vaccination schedule consists of two doses of 0.5 mL each:
an initial dose followed by a
second dose 2 months later.
If flexibility in the vaccination schedule is necessary, the second
dose can be administered between 2
and 6 months after the first dose (see section 5.1).
For subjects who are or might become immunodeficient or
immunosuppressed due to disease or therapy,
and whom would benefit from a shorter vaccination schedule, the second
dose can be given 1 to 2
months after the initial dose (see section 5.1).
The need for booster doses following the primary vaccination schedule
has not been established (see
section 5.1).
Shingrix can be given with the same schedule in individuals previously
vaccinated with live attenuated
HZ vaccine (see
_ _
s
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