natgillin/translations-raw huggingface dataset:
Det er endnu ikke fuldstændigt fastlagt, hvorvidt immunokompetente individer, som har responderet på hepatitis A vaccination, behøver en booster- dosis, eftersom der ved fravær af påviselige antistoffer muligvis kan opnås beskyttelse ved hjælp af immunologisk hukommelse.
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Vejledning vedrørende booster- vaccination er baseret på antagelsen om, at antistoffer er nødvendige for beskyttelse; antistoffer mod HAV forudses at kunne opretholdes i mindst 10 år.
Anti-HAV antibodies have been predicted to persist for at least 10 years.
Hypersensitivitet overfor de aktive stoffer, de øvrige indholdsstoffer eller neomycin.
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Hypersensitivitet efter forudgående indgift af hepatitis A og/ eller hepatitis B vacciner.
Hypersensitivity after previous administration of hepatitis A and/ or hepatitis B vaccines.
Som ved andre vacciner bør administrationen af Ambirix udskydes hos individer, der lider af akut alvorlig febril sygdom.
As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.
Det er muligt, at individer kan være i inkubationsfasen af en hepatitis A eller hepatitis B infektion på tidspunktet for vaccination.
3 It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
3 Vaccinen forhindrer ikke infektion forårsaget af andre vira så som hepatitis C og hepatitis E eller andre patogener, som er kendt for at inficere leveren.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Ambirix anbefales ikke til post- ekspositionsprofylakse (f. eks. stikuheld med kanyle).
Ambirix is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Hvis der kræves hurtig beskyttelse mod hepatitis B anbefales standard 3 dosis programmet af den kombinerede vaccine, som indeholder 360 ELISA enheder af formalin inaktiveret hepatitis A virus og 10 mikrogram rekombinant hepatitis B overflade antigen.
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Dette skyldes, at en større andel af de vaccinerede er beskyttede i intervallet mellem 2. og 3. dosis i 3 dosis programmet med den kombinerede vaccine, i forhold til efter en enkelt dosis Ambirix.
This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
5. 1 for serobeskyttende rater).
This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Det anbefales, at 2 dosis programmet for Ambirix er fuldført forud for seksuel debut.
It is recommended that the two-dose regimen of Ambirix be completed prior to start of sexual activity.
Hos hæmodialysepatienter og personer med nedsat immunforsvar opnås ikke altid et tilstrækkeligt niveau af HAV - og HB - antistoftitere efter det primære immuniseringsprogram.
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Da intradermal injektion eller intramuskulær administration i glutealregionen kan føre til et suboptimalt respons over for vaccinen, bør disse ruter undgås.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Undtagelsesvist kan Ambirix dog administreres subkutant hos individer med thrombocytopeni eller blødningsforstyrrelser, da blødning kan forekomme efter en intramuskulær administration hos sådanne individer.
However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Der foreligger ikke data for samtidig administration af Ambirix med specifik hepatitis A immunoglobulin eller hepatitis B immunoglobulin.
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
I tilfælde, hvor de monovalente hepatitis A og hepatitis B vacciner blev administreret sammen med specifikke immunoglobuliner, var der ingen påvirkning af serokonverteringsraterne.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Samtidig administration af immunoglobuliner kan resultere i lavere antistoftiter.
Concomitant immunoglobulin administration may result in lower antibody titres.
5. 1).
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1)
Hos patienter, som modtager immunosuppresiv behandling eller som er immundeficiente, kan tilstrækkeligt respons ikke altid forventes opnået.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Effekten af Ambirix på fosterudviklingen er ikke klarlagt.
4 The effect of Ambirix on foetal development has not been assessed.
Ambirix bør ikke anvendes under graviditet, medmindre, det er på tvingende indikation.
Ambirix should not be used during pregnancy unless it is clearly necessary.
Effekten på ammede børn af administration af Ambirix til deres mødre er ikke evalueret i kliniske undersøgelser.
The effect on breastfed infants of Ambirix administered to the mothers has not been evaluated in clinical studies.
Ambirix bør ikke anvendes under amning, medmindre, det er på tvingende indikation.
Ambirix should not be used during lactation unless it is clearly necessary.
4 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Døsighed og svimmelhed kan af og til forekomme og kan have indflydelse på evnen til at føre bil eller betjene maskiner
Drowsiness and dizziness can sometimes occur and may affect the ability to drive and use machines.
Ambirix indeholder ikke thiomersal (en organisk kviksølvforbindelse) eller andre konserveringsmidler.
The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative.
I kliniske undersøgelser udført med 3 doseringer af den nuværende formulering til voksne var forekomsten af smerter, rødme, hævelser, træthed, gastro- enteritis, hovedpine og feber sammenlignelig med, hvad der blev set ved administration af den tidligere formulering af vaccinen indeholdende thiomersal og konserveringsmidler.
In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation.
De her nævnte bivirkninger er rapporteret efterfølgende den almindelig udbredte anvendelse af den tidligere formulering af vaccinen.
The following adverse reactions have been reported following the widespread use of the former formulation
I kliniske undersøgelser indgik administration af 2029 doser Ambirix til 1027 børn og unge i alderen fra 1 år til og med 15 år.
Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Lokale og generelle bivirkninger indberettet efter primær vaccination med Ambirix blev fordelt efter frekvens.
Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Hyppighederne er rapporteret nedenfor som:
Frequencies are reported below as:
≥ 1 / 10 ≥ 1 / 100 og < 1 / 10 ≥ 1 / 1000 og < 1 / 100 ≥ 1 / 10 000 og < 1 / 1000 < 1 / 10 000
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
Nervesystemet:
Nervous system disorders: very common: headache common: drowsiness
Meget almindelig: hovedpine Almindelig: døsighed
Gastrointestinal disorders: common: gastrointestinal symptoms
Almindelig: gastrointestinale symptomer
Metabolism and nutrition disorders very common: loss of appetite
Meget almindelig: appetitløshed
General disorders and administration site conditions very common: pain, redness, fatigue common: swelling, fever
Meget almindelig: smerter, rødmen, træthed Almindelig: hævelse, feber
Psychiatric disorders: very common: irritability/ fussiness
Meget almindelig: irritabilitet I en undersøgelse med 300 personer i alderen 12 år til og med 15 år blev reaktogenicitetsprofilen for Ambirix sammenlignet med profilen for den 3 dosis kombinerede vaccine.
In a study, in 300 subjects aged from 12 years up to and including 15 years, the reactogenicity profile of Ambirix was compared to that of the three-dose combined vaccine.
Den 3 dosis kombinerede vaccine indeholder 360 ELISA enheder af formalin inaktiveret hepatitis A virus og 10 mikrogram rekombinant hepatitis B overfladeantigen i 0, 5 ml.
The three-dose vaccine contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in 0.5 ml.
Forekomsten af lokale og generelle indsamlede bivirkninger efter et 2 dosis program med Ambirix svarede i store træk til forekomsten for den 3 dosis kombinerede vaccine, bortset fra en højere forekomst af smerte og træthed efter én dosis Ambirix, men ikke for det enkelte individ.
5 combined vaccine, the only exceptions being a higher incidence of pain and fatigue on a per dose basis after Ambirix, but not on a per subject basis.
Smerte blev rapporteret efter 50, 7% af doserne i Ambirix gruppen, sammenlignet med 39, 1% af doserne i 3 dosis kombinationsvaccine gruppen.
Pain was reported following 50.7% of doses in the Ambirix group, as compared to 39.1% of doses with the three dose combined vaccine.
Igennem hele vaccinationsforløbet blev smerte rapporteret hos 66, 4% af de vaccinerede i Ambirix gruppen, sammenlignet med 63, 8% af de vaccinerede i 3 dosis kombinationsvaccine gruppen.
However, over the complete vaccination course, 66.4% of subjects who received Ambirix reported pain, as compared to 63.8% of subjects who received the three dose combined vaccine.
5 Træthed blev rapporteret efter 29, 2% af doserne i Ambirix gruppen, sammenlignet med 19, 3% af doserne i 3 dosis kombinationsvaccine gruppen.
Fatigue was reported following 29.2% doses of Ambirix, as compared to 19.3% doses of the three dose combined vaccine.
39, 6% versus 36, 2% af individerne i henholdsvis Ambirix gruppen og 3 dosis kombinationsvaccine gruppen set over det samlede vaccinationsforløb).
However, the incidence of fatigue was similar based on a per subject analysis (i. e. over the total vaccination course, 39.6% versus 36.2% of subjects for Ambirix and the three dose vaccine respectively).
Forekomsten af svær smerte og træthed var lav, og sammenlignelig med den set for 3 dosis kombinationsvaccinen.
The incidence of pain and fatigue graded as severe was low and similar to that observed with the three dose combined vaccine.
I en sammenlignende undersøgelse med børn fra 1- 11 år var forekomsterne af lokale og generelle symptomer i Ambirix gruppen ens med dem som sås for 3 dosis kombinationsvaccinen indeholdende 360 ELISA enheder af formalin inaktiveret hepatitis A virus og 10 microgram rekombinant hepatitis B overfladeantigen.
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Undtagelsen var en højere forekomst af smerte efter indgift af Ambirix hos 6- 11 årige, pr. dosis vaccine men ikke pr. person.
The exception was a higher incidence of pain after Ambirix in 6-11 year olds on a per dose basis, but not on a per subject basis.
Der var ingen statistisk forskel i procentandelen af de vaccinerede personer, der rapporterede om symptomer, der kan betegnes som alvorlige i løbet af 2 dosis programmet for Ambirix eller 3 dosis programmet af den kombinerede vaccine, som indeholder 360 ELISA enheder af formalin inaktiveret hepatitis A virus og 10 mikrogram rekombinant hepatitis B overfladeantigen.
The percentages of vaccinees reporting any solicited symptom graded as severe during a two-dose regimen of Ambirix or a three dose regimen with the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen, were not statistically different.
Under postmarketing overvågning af 3 dosis kombinationsvaccinen indeholdende 360 ELISA enheder af formalin inaktiveret hepatitis A virus og 10 mikrogram rekombinant hepatitis B overfladeantigen i en dosis på 0, 5 ml (anbefales til personer fra 1 år til og med 15 år) eller 720 ELISA enheder af formalin inaktiveret hepatitis A virus og 20 mikrogram rekombinant hepatitis B overfladeantigen i en dosis på 1 ml (anbefales til personer fra og med 16 år), er følgende bivirkninger blevet rapporteret.
During post-marketing surveillance with the three dose combined vaccine containing either 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml (recommended for subjects 1 year up to and including 15 years of age) or 720 ELISA Units of formalin inactivated hepatitis A virus and 20 micrograms of recombinant hepatitis B surface antigen in a dose volume of 1 ml (recommended from the age of 16 years onwards), the following adverse reactions have been reported.
Undersøgelser Unormale leverfunktionstest
Investigations abnormal liver function tests
Trombocytopeni, thombocytopenia purpura, lymphadenopathia
Blood and lymphatic system disorders thrombocytopenia, thrombocytopenic purpura, lymphadenopathy
Synkope, svimmelhed, paræstesi, kramper
Nervous system disorders syncope, dizziness, paresthesia, convulsions
Kvalme, opkast, diaré, mavesmerter
Gastrointestinal disorders: nausea, vomiting, diarrhoea, abdominal pain
Udslæt, pruritus, urticaria
Skin and subcutaneous tissue disorders rash, pruritis, urticaria
Nedsat appetit
Metabolism and nutrition disorders decreased appetite
Hypotension
Vascular disorders Hypotension
Influenza- lignende symptomer, træthed
General disorders and administration site conditions flu-like symptoms, fatigue
6 Nervesystemet:
6 Immune system disorders allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease
Multipel sklerose, myelitis, facialisparese, polyneuritis såsom Guillain- Barré syndrom (med ascenderende pralyse), encephalitis, encephalopathia.
Nervous system disorders multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), encephalitis, encephalopathy
Optisk neuritis
Eye disorders optic neuritis
Erythema exsudatio multiforme
Skin and subcutaneous tissue disorders erythema exsudativum multiforme
Meningitis
Infections and infestations meningitis
Vasculitis
Vascular disorders vasculitis
JO7BC20
Hepatitis vaccines, ATC code J07BC20.
Ambirix giver immunitet mod HAV - og HBV- infektion ved at inducere specifikke HAV - og HBs - antistoffer.
Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti- HBs antibodies.
I kliniske undersøgelser med individer fra 1 år til og med 15 år, var de sero- positive rater for HAV antistoffer 99, 1% en måned efter den første vaccination og 100% efter den anden dosis givet i 6. måned (dvs. måned 7).
In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i. e month 7).
Sero- positive rater for HBs- antistoffer var 74, 2% en måned efter første vaccination og 100% efter den anden dosis givet i 6. måned (dvs. måned 7).
Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i. e. month 7).
Anti- HBs sero - beskyttende rater (titre ≥ 10mlU/ ml) var henholdsvis 37, 4% og 98, 2%.
The anti-HBs seroprotection rates (titers ≥ 10 mlU/ ml) at these time points were 37.4% and 98.2% respectively.
I en sammenlignende undersøgelse udført blandt personer i alderen fra 12 år til og med 15 år, var der 142, som modtog 2 dosis Ambirix og 147 som modtog standard 3 dosis kombineret vaccine.
In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
Sidstnævnte indeholdt 360 ELISA enheder af formalin inaktiveret hapatitis A virus og 10 mikrogram rekombinant hepatitis B overfladeantigen.
The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Hos de 289 individer hvis immunisering blev undersøgt var sero- beskyttelsesraten (SP i nedenstående tabel) for hepatitis B signifikant højere ved 2 og 6 måneder med 3 dosis vaccinen end for Ambirix.
For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Anti- HBs Måned 2 SP (%)
Anti-HBs Month 2 SP (%)
Anti- HBs Måned 6 SP (%)
Anti-HBs Month 6 SP (%)
Anti- HBs Måned 7 SP (%)
Anti-HBs Month 7 SP (%)
68. 3
68.3
97. 9
97.9
Kombineret HAB vaccine (360/ 10)
Combined HAB vaccine (360/ 10)
85. 6
85.6
98. 0
98.0
Anti- HAV S+ (%) N
Anti-HAV S+ (%) N
Anti- HBs SP (%)
Anti-HBs SP (%)
1- 5 år
1-5 yrs old
6- 11 år
6-11 yrs old
12- 15 år
12-15 yrs old
De sero- positive rater for anti- HAV var 99, 0% og de sero- positive rater for anti - HBs var 99, 0% i måned 13 med sero- beskyttende rater på 97, 0%.
In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12, seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Hos individer, der var 12- 15 år på tidspunktet for den første vaccination er persistensen af HAV - og HBs- antistoffer blevet påvist i mindst 24 måneder efter indledningen af et 0, 6 måneders program med Ambirix.
In subjects aged 12-15 years at the time of primary vaccination, anti-HAV and anti-HBs antibodies have been shown to persist for at least 24 months following the initiation of a 0, 6 month schedule of Ambirix.
De sero- positive rater var henholdsvis 100% og 94, 2% for antiHAV og antiHBs i måned 24.
Seropositivity rates were 100% and 94.2% respectively for anti-HAV and anti-HBs antibodies at month 24.
Sero- beskyttelsesraten for antiHBs var på dette tidspunkt 93, 3%.
The seroprotection rate for anti-HBs at this time point was 93.3%.
I denne undersøgelse var immun - responset over for begge antigene komponenter sammenlignelig med den set efter et 3- dosis program med den kombinerede vaccine indeholdende 360 ELISA units formalin inaktiveret hepatitis A- virus og 10µg rekombinant hepatitis B overfladeantigen i en dosis på 0, 5 ml.
In this study, the immune response to both antigen components was comparable to that seen after a 3-dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10µg of recombinant hepatitis B surface antigen in a dose volume of 0.5 ml.
I en klinisk undersøgelse blandt individer i alderen fra 12 år til og med 15 år var persistensen af anti - HAV og anti- HBs antistoffer ved 24. måned den samme efter et 0, 6 måneders doseringsprogram eller et 0, 12 måneders program.
In a clinical study involving subjects from 12 years up to and including 15 years of age, the persistence of anti-HAV and anti-HBs antibodies at month 24 was shown to be similar following a 0, 6 month or a 0, 12 month schedule.
Når den første dosis med Ambirix blev administreret samtidig med en booster- dosis med en kombineret difteri, tetanus, acellulær pertussis, inaktiveret poliomyelitis og Haemophilus influenzae type b vaccine (DTPa- IPV/ Hib) eller med en kombineret vaccine mod mæslinger- fåresyge- røde hunde i andet leveår, var immunresponset over for alle antigener tilfredsstillende.
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV/ Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Disse data er resultater for den tidligere Ambirix formulering indeholdende thiomersal og konserveringsmiddel.
These data were generated with the former Ambirix formulation containing thiomersal and a preservative.
I en klinisk undersøgelse udført med 3 doseringer af den nuværende formulering til voksne fremkom tilsvarende serobeskyttelse og serokonverteringsgrader sammenlignet med den tidligere formulering.
A clinical study conducted with 3 doses of the current formulation in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.
Prækliniske data viser ikke nogen specifikke humane risikofaktorer baseret på generelle sikkerhedsstudier.
Non-clinical data reveal no special hazard for humans based on general safety studies.
8 Natriumklorid Vand til injektion.
PHARMACEUTICAL PARTICULARS
2.
6.1 List of excipients
Opbevares i køleskab (2°C – 8°C)
Store in a refrigerator (2°C - 8°C).
1 ml suspension i fyldt injektionssprøjte (type I glas) med en sprøjtestempel (butylgummi).
1 ml of suspension in a prefilled syringe (type I glass) with a plunger stopper (rubber butyl).
Pakningsstørrelse på 1 og 10 med eller uden kanyle og pakningsstørelse på 50 uden kanyle.
Pack sizes of 1 and 10 with or without needles and pack size of 50 without needles.
Vaccinen skal inspiceres visuelt både før og efter resuspension for fremmede partikler og/ eller variationer i det fysiske udseende.
The vaccine should be visually inspected both before and after resuspension for any foreign particulate matter and/ or change in physical appearance.
Vaccinen må ikke anvendes, hvis der er sket en ændring i vaccinens udseende.
The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Al ubrugt vaccine eller spildprodukt skal bortskaffes i overensstemmelse med gældende lokale regler.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Rue de l' Institut 89 B- 1330 Rixensart, Belgien
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
9 9.
9 8.
Første markedsføringstilladelse:
Date of first authorisation:
30. august 2002 Sidste fornyelse af markedsføringstilladelsen:
30 August 2002 Date of latest renewal:
10 BILAG II
10 ANNEX II
FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER AF DE BIOLOGISKE AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE