SHINGRIX

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J07BK03

الشكل الصيدلاني:

POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

تركيب:

VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 MCG

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO SMITH KLINE BIOLOGICALS S.A

المجال العلاجي:

ZOSTER, PURIFIED ANTIGEN

الخصائص العلاجية:

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.

تاريخ الترخيص:

2023-01-03

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Shingrix
Powder and suspension for suspension for injection
After reconstitution, each dose (0.5 mL) contains:
Varicella Zoster Virus glycoprotein E (gE) antigen
50 micrograms
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 – "Important information about some of the ingredients in
the
medicine" and section 6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Shingrix is intended for prevention of shingles [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 shingles
[herpes zoster
(HZ)].
The use of Shingrix should be in accordance with official
recommendations.
Shingrix cannot be used to prevent chickenpox (varicella).
Therapeutic group: Herpes zoster vaccines.
What shingles (herpes zoster) 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
the nerve cells.
• Sometimes, after many years, if your immune system (the body’s
natural
defence system) becomes weaker (due to age, an illness or medicines
you
are taking), the virus can cause shingles.
Complications related to shingles
Shingles may cause complications.
The most common complication of shingles is:
• long-lasting nerve pain, called post-herpetic neuralgia or P

خصائص المنتج

1
Summary of Product characteristics
1.
NAME OF THE MEDICINAL PRODUCT
SHINGRIX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus (VZV) glycoprotein E (gE) antigen
1
50 micrograms
1
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
_ _
section 5.1).
2
Shingrix is not indicated for prevention of primary varicella
infection (chickenpox).
_Paediatric population _
The safety and efficacy of Shingrix in children and adolescents under
the age of 18 years have not been
established.
No data are available.
Method of administration
For intramuscular injection only, preferably