Shingrix

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Recombinant varicella zoster virus glycoprotein E 50ug

Inapatikana kutoka:

GlaxoSmithKline NZ Limited

Kipimo:

50 mcg

Dawa fomu:

Suspension for injection

Tungo:

Active: Recombinant varicella zoster virus glycoprotein E 50ug Excipient: Dibasic potassium phosphate Monobasic sodium phosphate as dihydrate Polysorbate 80 Sucrose Cholesterol Dibasic sodium phosphate Dioleoylphosphatidylcholine Monobasic potassium phosphate Monophosphoryl lipid A Quillaja saponaria Sodium chloride Water for injection

Dawa ya aina:

Prescription

Matibabu dalili:

SHINGRIX is indicated for the 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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Combination pack, 1 x antigen vial + 1 x adjuvant vial - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x antigen vial + 10 x adjuvant vial - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Adjuvant component - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Antigen component - 1 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Adjuvant component - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Antigen component - 10 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Idhini ya tarehe:

2018-09-04

Taarifa za kipeperushi

SHINGRIX
1
SHINGRIX
_50 micrograms powder and 50 micrograms adjuvant suspension for
suspension for injection _
_Recombinant Varicella Zoster Virus glycoprotein E Vaccine _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using SHINGRIX.
This leaflet answers some common
questions about SHINGRIX. It does
not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the risks of you receiving
SHINGRIX against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING SHINGRIX, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE VACCINE
You may need to read it again.
WHAT SHINGRIX IS
USED FOR
SHINGRIX is a vaccine that helps to
protect adults against herpes zoster
(also called shingles) as well as the
long-lasting nerve pain that can
follow shingles called post-herpetic
neuralgia or PHN.
SHINGRIX can be given to:
•
adults from the age of 50 years
and above
•
adults from the age of 18 years
and above who are at increased
risk of shingles.
WHAT IS SHINGLES AND WHAT ARE THE
COMPLICATIONS RELATED TO SHINGLES?
Shingles is caused by the same virus
that causes chickenpox. After you
have had chickenpox (primary
varicella infection), the virus that
caused it stays in your body in nerve
cells. Sometimes, after many years,
the virus can become active again
and causes shingles (secondary
varicella infection).
SHINGRIX cannot be used to
prevent chickenpox (primary
varicella infection).
Shingles is a painful, blistering rash.
It usually occurs in one part of the
body and can last for several weeks.
It may lead to complications such as
long-lasting pain (PHN) and scarring.
Less commonly, bacterial skin
infections, weakness, muscle
paralysis, loss of hearing or vision
can occur.
WHAT IS POST-HERPETIC NEURALGIA
(PHN)?
After the shingles blisters heal, pain
can last for months or years and may
b

Tabia za bidhaa

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SHINGRIX Recombinant Varicella Zoster Virus glycoprotein E antigen 50
micrograms
(AS01
B
adjuvanted vaccine) powder and suspension for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains 50 micrograms of gE
antigen
1
adjuvanted with
AS01B
2
.
1
Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by
recombinant DNA technology
in Chinese Hamster Ovary (CHO) cells
2
The GlaxoSmithKline proprietary AS01B Adjuvant System is composed of
the plant extract
Quillaja saponaria saponin (QS-21) (50 micrograms) and
3-O-desacyl-4’-monophosphoryl
lipid A (MPL) from Salmonella minnesota (50 micrograms) plus
excipients.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder and 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 the 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
The immunisation schedules for SHINGRIX should be based on official
recommendations.
DOSE
The primary vaccination schedule consists of two doses of 0.5 mL each;
an initial dose
followed by a second dose 2 to 6 months later.
For subjects who are immunodeficient, immunosuppressed or likely to
become
immunosuppressed due to known disease or therapy, and whom would
benefit from a
2
shorter vaccination schedule, the second dose can be given 1 to 2
months after the initial
dose (see section 5.1 Pharmacodynamic Properties).
The need for booster doses has not been established.
SHINGRIX can be given with the same schedule in individuals previously
vaccinated with
live attenuated HZ vaccine (see section 5.1 Pharmacodynamic
Properties).
SHINGRIX is not indicated for prevention of primary varicella
infection (chicken