4. EVENTUELLA BIVERKNINGAR Källa: FASS
Liksom alla läkemedel kan Cervarix orsaka biverkningar, men alla användare behöver inte få dem.
Följande biverkningar har rapporterats i kliniska prövningar:
Mycket vanliga (biverkningar som kan förekomma i fler än 1 av 10 vaccindoser):
smärta eller obehag vid injektionsstället
rodnad eller svullnad vid injektionsstället
huvudvärk
värk, ömhet eller svaghet i musklerna som inte är orsakad av träning
trötthet.
Vanliga (biverkningar som kan förekomma i färre än 1 av 10 men i fler än 1 av 100 vaccindoser):
magtarmbesvär såsom illamående, kräkning, diarré och buksmärta
klåda, röda hudutslag, nässelfeber (nässelutslag)
ledvärk
feber ( 38 °C eller mer).
Mindre vanliga (biverkningar som kan förekomma i färre än 1 av 100 men i fler än 1 av 1 000 vaccindoser):
övre luftvägsinfektions (infektion i näsa, hals eller luftstrupe)
yrsel
andra symtom vid injektionsstället såsom en lokal förhårdnad, stickningar eller känselbortfall.
Biverkningar som rapporterats efter godkännandet av Cervarix:
allergiska reaktioner som känns igen genom:
utslag som kliar på händer och fötter.
svullnad av ögon och ansikte.
svårigheter att andas och svälja.
plötsligt blodtrycksfall och medvetandeförlust.
Dessa reaktioner inträffar normalt innan man lämnat vårdinrättningen. Om ditt barn får något av dessa symptom, kontakta omedelbart läkare.
svullnad av körtlar i hals, armhåla eller ljumske
svimning som ibland uppträder tillsammans med skakningar eller stelhet
Om några biverkningar blir värre eller om du märker några biverkningar som inte nämns i denna information, kontakta läkare eller apotekspersonal.
Detta kan du inte läsa om i FASS:
———————– WARNINGS AND PRECAUTIONS —————-
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. (5.1)
Do not use the prefilled syringes in latex sensitive individuals. (5.2)
—————————— ADVERSE REACTIONS ———————–
Most common local adverse reactions in ≥20% of subjects were pain, redness, and swelling at the injection site. (6.1)
Most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov/.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
———————– FÖRSIKTIGHETSÅTGÄRDER —————-
Eftersom vaccinerade kan utveckla synkope, ibland resulterande i fallande med skador, observation i 15 minuter efter tillförsel rekommenderas. Synkope, ibland i kombination med tonisk-kloniska kramper och andra beslag-liknande aktivitet, har rapporterats efter vaccination med Cervarix. När synkope är förknippad med tonisk-kloniska rörelser, är aktiviteten vanligen övergående och vanligen svarar att återställa cerebral perfusion genom att upprätthålla en liggande eller chockläge. (5.1)
Använd inte den förfyllda sprutor i latex känsliga individer. (5.2)
—————————— BIVERKNINGAR —————— —–
Vanligaste lokala biverkningar hos ≥ 20% av patienterna var smärta, rodnad och svullnad vid injektionsstället. (6.1)
Vanligaste allmänna oönskade händelser hos ≥ 20% av försökspersonerna var trötthet, huvudvärk, myalgi, gastrointestinala symtom, och artralgi. (6.1)
För att rapportera misstänkta biverkningar, kontakta GlaxoSmithKline på 1-888-825-5249 eller VAERS på 1-800-822-7967 eller http://www.vaers.hhs.gov/.
5 WARNINGS AND PRECAUTIONS
5.1 Syncope
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
5 VARNINGAR OCH
5,1 Synkope
Eftersom vaccinerade kan utveckla synkope, ibland resulterande i fallande med skador, observation i 15 minuter efter tillförsel rekommenderas. Synkope, ibland i kombination med tonisk-kloniska kramper och andra beslag-liknande aktivitet, har rapporterats efter vaccination med Cervarix. När synkope är förknippad med tonisk-kloniska rörelser, är aktiviteten vanligen övergående och vanligen svarar att återställa cerebral perfusion genom att upprätthålla en liggande eller chockläge.
Vad Är Syn·co·pe NOUN:
1. Grammar The shortening of a word by omission of a sound, letter, or syllable from the middle of the word; for example, bos’n for boatswain.
2. Pathology A brief loss of consciousness caused by a temporary deficiency of oxygen in the brain; a swoon. See Synonyms at blackout
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
CERVARIX has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no effect on fertility.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
(CERVARIX har inte utvärderats för dess cancerogena eller mutagena potential. Vaccination av honråttor med Cervarix, vid doser visat signifikant immunogent på råtta, hade ingen effekt på fertiliteten.
Man har alltså inte utvärderat om vaccinet kan ge vaccinmottagaren cancer eller ej, eller om vaccinet har andra biverkningar som muteringar.)
6.1 Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of CERVARIX could reveal adverse reactions not observed in clinical trials.
Studies in Females 10 Through 25 Years of Age: The safety of CERVARIX was evaluated by pooling data from controlled and uncontrolled clinical trials involving 23,713 females 10 through 25 years of age in the pre-licensure clinical development program. In these studies, 12,785 females (10 through 25 years of age) received at least one dose of CERVARIX and 10,928 females received at least one dose of a control [Hepatitis A Vaccine containing 360 EL.U. (10 through 14 years of age), Hepatitis A Vaccine containing 720 EL.U. (15 through 25 years of age), or Al(OH)3 (500 mcg, 15 through 25 years of age)]
Data on solicited local and general adverse events were collected by subjects or parents using standardized diary cards for 7 consecutive days following each vaccine dose (i.e., day of vaccination and the next 6 days). Unsolicited adverse events were recorded with diary cards for 30 days following each vaccination (day of vaccination and 29 subsequent days). Parents and/or subjects were also asked at each study visit about the occurrence of any adverse events and instructed to immediately report serious adverse events throughout the study period. These studies were conducted in North America, Latin America, Europe, Asia, and Australia . Overall, the majority of subjects were white (59%), followed by Asian (26%), Hispanic (9%), black (3%), and other racial/ethnic groups (3%).
Solicited Adverse Events: The reported frequencies of solicited local injection site reactions (pain, redness, and swelling) and general adverse events (fatigue, fever, gastrointestinal symptoms, headache, arthralgia, myalgia, and urticaria) within 7 days after vaccination in females 10 through 25 years of age are presented in Table 1. An analysis of solicited local injection site reactions by dose is presented in Table 2. Local reactions were reported more frequently with CERVARIX when compared with the control groups; in ≥84% of recipients of CERVARIX, these local reactions were mild to moderate in intensity. Compared with dose 1, pain was reported less frequently after doses 2 and 3 of CERVARIX, in contrast to redness and swelling where there was a small increased incidence. There was no increase in the frequency of general adverse events with successive doses.
Deaths: In completed and ongoing studies which enrolled 57,323 females 9 through 72 years of age, 37 deaths were reported during the 7.4 years of follow-up: 20 in subjects who received CERVARIX (0.06%, 20/33,623) and 17 in subjects who received control (0.07%, 17/23,700). Causes of death among subjects were consistent with those reported in adolescent and adult female populations. The most common causes of death were motor vehicle accident (5 subjects who received CERVARIX; 5 subjects who received control) and suicide (2 subjects who received CERVARIX; 5 subjects who received control), followed by neoplasm (3 subjects who received CERVARIX; 2 subjects who received control), autoimmune disease (3 subjects who received CERVARIX; 1 subject who received control), infectious disease (3 subjects who received CERVARIX; 1 subject who received control), homicide (2 subjects who received CERVARIX; 1 subject who received control), cardiovascular disorders (2 subjects who received CERVARIX), and death of unknown cause (2 subjects who received control). Among females 10 through 25 years of age, 31 deaths were reported (0.05%, 16/29,467 of subjects who received CERVARIX and 0.07%, 15/20,192 of subjects who received control.
…….
Liksom alla läkemedel kan Cervarix orsaka biverkningar, men alla användare behöver inte få dem.
Följande biverkningar har rapporterats i kliniska prövningar:
Mycket vanliga (biverkningar som kan förekomma i fler än 1 av 10 vaccindoser):
smärta eller obehag vid injektionsstället
rodnad eller svullnad vid injektionsstället
huvudvärk
värk, ömhet eller svaghet i musklerna som inte är orsakad av träning
trötthet.
Vanliga (biverkningar som kan förekomma i färre än 1 av 10 men i fler än 1 av 100 vaccindoser):
magtarmbesvär såsom illamående, kräkning, diarré och buksmärta
klåda, röda hudutslag, nässelfeber (nässelutslag)
ledvärk
feber ( 38 °C eller mer).
Mindre vanliga (biverkningar som kan förekomma i färre än 1 av 100 men i fler än 1 av 1 000 vaccindoser):
övre luftvägsinfektions (infektion i näsa, hals eller luftstrupe)
yrsel
andra symtom vid injektionsstället såsom en lokal förhårdnad, stickningar eller känselbortfall.
Biverkningar som rapporterats efter godkännandet av Cervarix:
allergiska reaktioner som känns igen genom:
utslag som kliar på händer och fötter.
svullnad av ögon och ansikte.
svårigheter att andas och svälja.
plötsligt blodtrycksfall och medvetandeförlust.
Dessa reaktioner inträffar normalt innan man lämnat vårdinrättningen. Om ditt barn får något av dessa symptom, kontakta omedelbart läkare.
svullnad av körtlar i hals, armhåla eller ljumske
svimning som ibland uppträder tillsammans med skakningar eller stelhet
Om några biverkningar blir värre eller om du märker några biverkningar som inte nämns i denna information, kontakta läkare eller apotekspersonal.
Detta kan du inte läsa om i FASS:
———————– WARNINGS AND PRECAUTIONS —————-
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. (5.1)
Do not use the prefilled syringes in latex sensitive individuals. (5.2)
—————————— ADVERSE REACTIONS ———————–
Most common local adverse reactions in ≥20% of subjects were pain, redness, and swelling at the injection site. (6.1)
Most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov/.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
———————– FÖRSIKTIGHETSÅTGÄRDER —————-
Eftersom vaccinerade kan utveckla synkope, ibland resulterande i fallande med skador, observation i 15 minuter efter tillförsel rekommenderas. Synkope, ibland i kombination med tonisk-kloniska kramper och andra beslag-liknande aktivitet, har rapporterats efter vaccination med Cervarix. När synkope är förknippad med tonisk-kloniska rörelser, är aktiviteten vanligen övergående och vanligen svarar att återställa cerebral perfusion genom att upprätthålla en liggande eller chockläge. (5.1)
Använd inte den förfyllda sprutor i latex känsliga individer. (5.2)
—————————— BIVERKNINGAR —————— —–
Vanligaste lokala biverkningar hos ≥ 20% av patienterna var smärta, rodnad och svullnad vid injektionsstället. (6.1)
Vanligaste allmänna oönskade händelser hos ≥ 20% av försökspersonerna var trötthet, huvudvärk, myalgi, gastrointestinala symtom, och artralgi. (6.1)
För att rapportera misstänkta biverkningar, kontakta GlaxoSmithKline på 1-888-825-5249 eller VAERS på 1-800-822-7967 eller http://www.vaers.hhs.gov/.
5 WARNINGS AND PRECAUTIONS
5.1 Syncope
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
5 VARNINGAR OCH
5,1 Synkope
Eftersom vaccinerade kan utveckla synkope, ibland resulterande i fallande med skador, observation i 15 minuter efter tillförsel rekommenderas. Synkope, ibland i kombination med tonisk-kloniska kramper och andra beslag-liknande aktivitet, har rapporterats efter vaccination med Cervarix. När synkope är förknippad med tonisk-kloniska rörelser, är aktiviteten vanligen övergående och vanligen svarar att återställa cerebral perfusion genom att upprätthålla en liggande eller chockläge.
Vad Är Syn·co·pe NOUN:
1. Grammar The shortening of a word by omission of a sound, letter, or syllable from the middle of the word; for example, bos’n for boatswain.
2. Pathology A brief loss of consciousness caused by a temporary deficiency of oxygen in the brain; a swoon. See Synonyms at blackout
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
CERVARIX has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no effect on fertility.
Källa: ©2010, GlaxoSmithKline. All rights reserved.
August 2010
CRX:4PI
(CERVARIX har inte utvärderats för dess cancerogena eller mutagena potential. Vaccination av honråttor med Cervarix, vid doser visat signifikant immunogent på råtta, hade ingen effekt på fertiliteten.
Man har alltså inte utvärderat om vaccinet kan ge vaccinmottagaren cancer eller ej, eller om vaccinet har andra biverkningar som muteringar.)
6.1 Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of CERVARIX could reveal adverse reactions not observed in clinical trials.
Studies in Females 10 Through 25 Years of Age: The safety of CERVARIX was evaluated by pooling data from controlled and uncontrolled clinical trials involving 23,713 females 10 through 25 years of age in the pre-licensure clinical development program. In these studies, 12,785 females (10 through 25 years of age) received at least one dose of CERVARIX and 10,928 females received at least one dose of a control [Hepatitis A Vaccine containing 360 EL.U. (10 through 14 years of age), Hepatitis A Vaccine containing 720 EL.U. (15 through 25 years of age), or Al(OH)3 (500 mcg, 15 through 25 years of age)]
Data on solicited local and general adverse events were collected by subjects or parents using standardized diary cards for 7 consecutive days following each vaccine dose (i.e., day of vaccination and the next 6 days). Unsolicited adverse events were recorded with diary cards for 30 days following each vaccination (day of vaccination and 29 subsequent days). Parents and/or subjects were also asked at each study visit about the occurrence of any adverse events and instructed to immediately report serious adverse events throughout the study period. These studies were conducted in North America, Latin America, Europe, Asia, and Australia . Overall, the majority of subjects were white (59%), followed by Asian (26%), Hispanic (9%), black (3%), and other racial/ethnic groups (3%).
Solicited Adverse Events: The reported frequencies of solicited local injection site reactions (pain, redness, and swelling) and general adverse events (fatigue, fever, gastrointestinal symptoms, headache, arthralgia, myalgia, and urticaria) within 7 days after vaccination in females 10 through 25 years of age are presented in Table 1. An analysis of solicited local injection site reactions by dose is presented in Table 2. Local reactions were reported more frequently with CERVARIX when compared with the control groups; in ≥84% of recipients of CERVARIX, these local reactions were mild to moderate in intensity. Compared with dose 1, pain was reported less frequently after doses 2 and 3 of CERVARIX, in contrast to redness and swelling where there was a small increased incidence. There was no increase in the frequency of general adverse events with successive doses.
Deaths: In completed and ongoing studies which enrolled 57,323 females 9 through 72 years of age, 37 deaths were reported during the 7.4 years of follow-up: 20 in subjects who received CERVARIX (0.06%, 20/33,623) and 17 in subjects who received control (0.07%, 17/23,700). Causes of death among subjects were consistent with those reported in adolescent and adult female populations. The most common causes of death were motor vehicle accident (5 subjects who received CERVARIX; 5 subjects who received control) and suicide (2 subjects who received CERVARIX; 5 subjects who received control), followed by neoplasm (3 subjects who received CERVARIX; 2 subjects who received control), autoimmune disease (3 subjects who received CERVARIX; 1 subject who received control), infectious disease (3 subjects who received CERVARIX; 1 subject who received control), homicide (2 subjects who received CERVARIX; 1 subject who received control), cardiovascular disorders (2 subjects who received CERVARIX), and death of unknown cause (2 subjects who received control). Among females 10 through 25 years of age, 31 deaths were reported (0.05%, 16/29,467 of subjects who received CERVARIX and 0.07%, 15/20,192 of subjects who received control.
…….
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