Silgard
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-04-2019
Charakterystyka produktu
(SPC)
02-04-2019
Sprawozdanie z oceny publicznego
(PAR)
02-04-2019
Składnik aktywny:
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein
Dostępny od:
Merck Sharp Dohme Ltd
Kod ATC:
J07BM01
INN (International Nazwa):
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Grupa terapeutyczna:
Vaccines
Dziedzina terapeutyczna:
Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
Wskazania:
Silgard is a vaccine for use from the age of 9 years for the prevention of:premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types;genital warts (condyloma acuminata) causally related to specific HPV types.See sections 4.4 and 5.1 for important information on the data that support this indication.The use of Silgard should be in accordance with official recommendations.
Podsumowanie produktu:
Revision: 33
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-09-19
Ulotka dla pacjenta
36
B. PACKAGE LEAFLET
(VIAL)
Medicinal product no longer authorised
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
SILGARD, SUSPENSION FOR INJECTION
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant,
adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Silgard is and what it is used for
2.
What you need to know before you receive Silgard
3.
How Silgard is given
4.
Possible side effects
5.
How to store Silgard
6.
Contents of the pack and other information
1.
WHAT SILGARD IS AND WHAT IT IS USED FOR
Silgard is a vaccine. Vaccination with Silgard is intended to protect
against diseases caused by Human
Papillomavirus (HPV) types 6, 11, 16, and 18.
These diseases include pre-cancerous lesions of the female genitals
(cervix, vulva, and vagina); pre-
cancerous lesions of the anus and genital warts in males and females;
cervical and anal cancers. HPV
types 16 and 18 are responsible for approximately 70% of cervical
cancer cases, 75-80% of anal
cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva
and vagina; 75% of HPV related
pre-cancerous lesions of the anus. HPV types 6 and 11 are responsible
for approximately 90% of
genital wart cases.
Silgard is intended to prevent these diseases. The vaccine is not used
to treat HPV related diseases.
Silgard does not have any effect in individuals who already have a
persistent infection or disease
associated with any of the HPV types in the vaccine. However, in
individuals who are already infected
with one or more of the vaccine HPV types, Silgard can still protect
against diseases associated with
the other HPV types in the vaccine.
Silgard cannot cause the diseases it protects against.
Silgard produces type-spec
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Silgard, suspension for injection.
Silgard, suspension for injection in a pre-filled syringe.
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant,
adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains approximately:
Human Papillomavirus
1
Type 6 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 11 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 16 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 18 L1 protein
2,3
20 micrograms.
1
Human Papillomavirus = HPV.
2
L1 protein in the form of virus-like particles produced in yeast cells
(_Saccharomyces cerevisiae_
CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
3
adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant
(0.225 milligrams Al).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Silgard, suspension for injection.
Silgard, suspension for injection in a pre-filled syringe.
Prior to agitation, Silgard may appear as a clear liquid with a white
precipitate. After thorough
agitation, it is a white, cloudy liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Silgard is a vaccine for use from the age of 9 years for the
prevention of:
–
premalignant genital lesions (cervical, vulvar and vaginal),
premalignant anal lesions, cervical
cancers and anal cancers causally related to certain oncogenic Human
Papillomavirus (HPV)
types
–
genital warts (condyloma acuminata) causally related to specific HPV
types.
See sections 4.4 and 5.1 for important information on the data that
support this indication.
The use of Silgard should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 9 to and including 13 years of age_
Silgard can be administered according to a 2-dose schedule (0.5 ml at
0, 6 months) (see section 5.1).
If the second vaccine dose is administered earlier than 6 months after
the f
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