natgillin/translations-raw huggingface dataset:
Den første vaccinedosis kan indgives på samme dag som humant hepatitis B-immunglobulin, men der skal anvendes forskellige
The first vaccine dose can be injected on the same day as human hepatitis B immunoglobulin, however in different sites.
Se pkt.
oC).
- Patienter, der er i behandling med bloddialyse, indtil vaccinationen virker.
- Haemodialysed patients, until vaccination has become effective.
Dette skyldes, at ImmunoGam kan påvirke din reaktion på visse vacciner med levende svækket virus mod f.eks. fåresyge, røde hunde, mæslinger og skoldkopper.
This is because ImmunoGam may interfere with the response to some attenuated vaccines, such as measles, rubella, mumps, and chicken pox.
Hvis indgivelse af humant hepatitis B-immunglobulin er nødvendig inden for tre til fire uger efter vaccinationen, skal der foretages revaccination tre måneder efter indgivelse af humant hepatitis B
Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of
Der er ikke rapporteret om bivirkninger ved brug af ImmunoGam til indikationer for immunprofylakse mod
No adverse events were reported in the post marketing use of ImmunoGam for Immunoprophylaxis of
Forholdsreglerne har muligvis begrænset virkning på ikke-indkapslede virus som hepatitis A-virus og den såkaldte parvovirus B19.
The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
• Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
• Please tell your doctor or nurse, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription e.g. herbal medicines.
Under behandlingen af blodet eller plasmaet sørger fremstillerne af denne type lægemidler desuden for at inaktivere eller fjerne virus.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
På grund af risikoen for chok skal det kontrolleres, at ImmunoGam ikke indgives i et blodkar.
Ensure that ImmunoGam is not administered into a blood vessel, because of the risk of shock.
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE IMMUNOGAM
BEFORE YOU RECEIVE IMMUNOGAM
Bivirkninger som kuldegysninger, hovedpine, feber, opkastning, allergiske reaktioner, kvalme, artralgi, lavt blodtryk og moderate lændesmerter kan generelt forekomme periodisk i forbindelse med immunglobulinprodukter.
In general for immunoglobulin products, adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Nedenstående tabel viser de bivirkninger, der er forbundet med lægemidlet og opstået inden for 7 dage efter indgivelse af ImmunoGam og er konstateret i forbindelse med kliniske forsøg med intramuskulær indgivelse:
Related undesirable effects within 7 days of ImmunoGam administration, from clinical trials conducted using the intramuscular route of administration is tabulated below:
4.4 vedrørende sikkerhed i forbindelse med overførsel af smitstoffer.
For safety with respect to transmissible agents, see section 4.4
ImmunoGam bør have stuetemperatur (ca. 20 ºC - 25ºC) før brug.
ImmunoGam should be brought to room temperature (approximately 20 ºC to 25ºC) before use.
- Hos personer, der ikke er vaccineret, og som ved et uheld bliver udsat for smitte (inklusive personer, hvor vaccinationen endnu ikke er komplet, eller hvor det ikke vides, om den er komplet).
- Accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or
De fleste af disse er immunglobulin G (IgG), som er taget fra blodplasma fra omhyggeligt
ImmunoGam contains increased levels of human hepatitis B immunoglobulins mainly immunoglobulin G (IgG) and is obtained from blood plasma of screened donors from
Hver 2. måned, til der konstateres en virkning (serokonvertering efter vaccination) Indgivelse af hepatitis B-immunglobulin skal muligvis gentages, til der konstateres serokonvertering efter vaccination
The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination
På trods af disse forholdsregler kan muligheden for overførsel af infektioner ikke helt udelukkes, når der indsprøjtes lægemidler fremstillet af blod eller plasma fra mennesker.
Despite these measures, when medicines prepared from human blood or plasma are administered the possibility of passing on infection cannot be totally excluded.
Denne forholdsregel betragtes som effektive for indkapslede virus som HIV (human immundefektvirus),
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.
- Personer, der er blevet vaccineret, men ikke reagerer på vaccinen (ikke har målbare hepatitis B-antistoffer i blodet), og som har brug for fortsat forebyggelse, fordi de stadig har risiko for at blive smittet med
- Subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with
- Hos nyfødte, hvor moderen er bærer af hepatitis B-virus.
- In the newborn of a hepatitis B virus carrier-mother.
- Nyfødte, hvor moderen er bærer af hepatitis B-virus.
- Newborn of a hepatitis B virus carrier-mother.
Hvis du har brugt for meget ImmunoGam
If more ImmunoGam is used than recommended
ImmunoGam fås i hætteglas med 1 ml eller 5 ml, der indeholder 30-70 mg humant plasmaprotein pr. milliliter.
ImmunoGam comes in a 1 ml or 5 ml vial containing 30-70 mg/ml of human plasma protein of which 96% (312 IU/ml) is Immunoglobulin G (IgG).
På trods af dette kan muligheden for overførsel af infektionskilder ikke helt udelukkes ved indgivelse af lægemidler fremstillet af humant blod eller plasma.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Afhængigt af eksponeringsintensiteten snarest muligt efter eksponering og helst inden for
At least 500 IU depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours every 2 months until seroconversion following
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Hypersensitivity to any of the components.
Dette kan igen betyde, at der fejlagtigt ordineres insulin, hvilket kan resultere i for lavt blodsukker (hypoglykæmi).
This may result in falsely elevated glucose readings and consequently in the inappropriate administration of insulin which may result in hypoglycemia.
ImmunoGam kan medføre en stigning i antallet af forskellige overførte antistoffer.
ImmunoGam may cause a rise of various transferred antibodies which may result in misleading positive results of certain blood serum tests.
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får bivirkninger, som ikke er nævnt her.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Immunglobuliner er ikke sat i forbindelse med infektioner med hepatitis A eller parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Der skal tages hensyn til øvrige officielle retningslinjer for dosering og doseringsplaner ved intramuskulær
Consideration should also be given to dose and dose schedules for human hepatitis B immunoglobulin for intramuscular use recommended in other official guidance.
Bulgarien Tchaikapharma High Quality Medicines, Inc.
Tchaikapharma High Quality Medicines, Inc.
ORAL ANVENDELSE
ORAL USE
Danmark Strides Arcolab International Limited
Strides Arcolab International Limited
Spanien Accord Healthcare S.L.U.
Accord Healthcare S.L.U.
Belgien Mylan Bvba-Sprl
Mylan Bvba-Sprl
Ungarn Fresenius Kabi Hungary Kft.
Fresenius Kabi Hungary Kft.
KAPSEL
CAPSULE
PULVER TIL KONCENTRAT TIL
POWDER FOR CONCENTRATE FOR
Kroatien Pliva Hrvatska D.O.O.
Pliva Hrvatska D.O.O.
Slovenien Pfizer Luxembourg Sarl
Pfizer Luxembourg Sarl
Grækenland Pharmaserve-Lilly Saci
Pharmaserve-Lilly Saci
Holland Pharma Regulatory Solutions Ltd.
Pharma Regulatory Solutions Ltd.
Spanien Laboratorio Ramon Sala, S.L
Laboratorio Ramon Sala, S.L
Tyskland Hexal Ag
Hexal Ag
Grækenland Demo Abee
Demo Abee
Rumænien Pharmaswiss česká Republika S.R.O.
Pharmaswiss česká Republika S.R.O.
Litauen Teva Pharma B.V.
Teva Pharma B.V.
Holland Fresenius Kabi Nederland B.V.
Fresenius Kabi Nederland B.V.
Grækenland Vianex S.A.
Vianex S.A.
Rumænien Fresenius Kabi Romania S.R.L.
Fresenius Kabi Romania S.R.L.
Spanien Pfizer, S.L.
Pfizer, S.L.
Tyskland Dr. Friedrich Eberth Arzneimittel Gmbh
Dr. Friedrich Eberth Arzneimittel Gmbh
Cypern Pharmaceutical Trading Co Ltd
Pharmaceutical Trading Co Ltd
Belgien Teva Pharma Belgium N.V.-S.A
Teva Pharma Belgium N.V.-S.A
Spanien Mylan Pharmaceuticals, S.L.
Mylan Pharmaceuticals, S.L.
Frankrig Fresenius Kabi France S.A.S.
Fresenius Kabi France S.A.S.
Holland Mylan B.V.
Mylan B.V.
Holland Eurocept B.V.
Eurocept B.V.
Spanien Kern Pharma, S.L.
Kern Pharma, S.L.
Luxembourg Sandoz N.V.
Sandoz N.V.
Spanien Fresenius Kabi España S.A.U.
Fresenius Kabi España S.A.U.
Kroatien Pharmaswiss D.O.O.
Pharmaswiss D.O.O.
Indústria Farmacêutica, S.A.
Generis Farmacêutica, S.A.
Cypern Sapiens Pharmaceuticals Ltd
Sapiens Pharmaceuticals Ltd
KAPSEL, HÅRD
CAPSULE, HARD ORAL USE
Holland Sandoz B.V.
Sandoz B.V.
Holland Pfizer B.V.
Pfizer B.V.
Kroatien Sandoz D.O.O.
Sandoz D.O.O.
Anfarm Hellas, S.A
Anfarm Hellas, S.A Vangrotin
Pharmatex Italia Srl
Pharmatex Italia Srl Vancotex
INHALATION
INHALATION USE
Det Forenede Flynn Pharma Ltd.
United Kingdom Flynn Pharma Ltd.
Laboratórios AzevedosIndústria Farmacêutica, S.A.
Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Grækenland Finixfarm Ltd
Finixfarm Ltd
Tyskland Fresenius Kabi Deutschland Gmbh
Fresenius Kabi Deutschland Gmbh
PULVER TIL ORAL
POWDER FOR ORAL SOLUTION
Kroatien Fresenius Kabi D.O.O.
Fresenius Kabi D.O.O.
Accord Healthcare Limited Vancomicina Combino
Accord Healthcare Limited
VANCOMYCINHYDROCHLORID 1025 MG/1025 MG
VANCOMYCIN HYDROCHLORIDE 1025MG/1025 MG
Vancotex
Levovanox
S.A
G
Mcdermott Laboratories Ltd Vancomycin Mylan
Mcdermott Laboratories Ltd
Vancomycin Wockhardt Uk Ltd
Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd
Enterprises Ltd.
Noridem Enterprises Ltd
Laboratorio Reig Jofre, S.A. Vancomycin Laboratorio
United Kingdom Laboratorio Reig Jofre, S.A.
Tyskland Lyomark Pharma Gmbh Vancomycin Lyomark
Lyomark Pharma Vancomycin Lyomark VANCOMYCIN
VANCOMYCINHYDROCHLORID 512,5 MG/512,5 MG
VANCOMYCIN HYDROCHLORIDE 512.5MG/512.5 MG
VANCOMYCINHYDROCHLORID 128,15 MG KAPSEL
VANCOMYCIN HYDROCHLORIDE 128.15MG CAPSULE
PULVER TIL ORAL OPLØSNING, PULVER
POWDER FOR ORAL SOLUTION, POWDER
Enterprises
Trading
VANCOMYCINHYDROCHLORID 1000 MG/1000 MG
VANCOMYCIN HYDROCHLORIDE 1000MG/1000 MG
Generics [uk] Limited Vancomycin Mylan
Generics [uk] Limited Vancomycin Mylan VANCOMYCIN 1000MG VIAL
PULVER TIL INJEKTIONSVÆSKE
POWDER FOR INJECTION
Vancomycin Hydrochloride Pharmaceutical Trading
Vancomycin Hydrochloride Pharmaceutical
PULVER TIL INFUSIONSVÆSKE, OPLØSNING / PULVER TIL ORAL OPLØSNING
POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION
Vancomycine Pfizer
Vancomycine Pfizer VANCOMYCIN
VANCOMYCINHYDROCHLORID 512,57 MG/10 ML
VANCOMYCIN HYDROCHLORIDE 512.57MG/10 ML
VANCOMYCIN 1000 MG/20 ML
Vancomycine Teva VANCOMYCIN 1000MG/20 ML
VANCOMYCINHYDROCHLORID 500 MG/500 MG
VANCOMYCIN HYDROCHLORIDE 500MG/500 MG
VANCOMYCIN 1000 MG PULVER TIL
VANCOMYCIN 500MG POWDER FOR
Holland Hospira Benelux Bvba Vancomycin Hospira
Hospira Benelux Vancomycin Hospira VANCOMYCIN
VANCOMYCINHYDROCHLORID 512,571 MG ENHEDER
VANCOMYCIN HYDROCHLORIDE 512.571MG UNITS
Tyskland Ratiopharm Gmbh
Ratiopharm Gmbh Vanco
Hospira Deutschland Gmbh Vanycin
Hospira Deutschland Gmbh
Tyskland Fresenius Kabi Deutschland Vancomycin VANCOMYCIN 500 MG PULVER TIL
Fresenius Kabi ванкомицин каби VANCOMYCIN 500MG POWDER FOR
VANCOMYCINHYDROCHLORID 0,5 G FLASKE
VANCOMYCIN HYDROCHLORIDE 0.5G BOTTLE
ORAL OPLØSNING, PULVER TIL
ORAL SOLUTION, POWDER FOR INFUSION
Vancomycin VANCOMYCINHYDROCHLORID 1 G FLASKE
VANCOMYCIN HYDROCHLORIDE 1G BOTTLE
VANCOMYCINHYDROCHLORID 50 MG/ML
HYDROCHLORIDE 50MG/ML
Vancomicina CNP
Vancocin Cp
VANCOMYCIN 125 MG KAPSEL
VANCOMYCIN 125MG CAPSULE
Tyskland Hikma Farmacêutica (Portugal), S.A.
United Kingdom Hikma Farmacêutica (Portugal), S.A.
Holland Hikma Farmacêutica (Portugal), S.A.
Vancomycin Hikma Farmacêutica (Portugal), S.A.
Morningside Healthcare Ltd Vancomycin Morningside
Vancomycin Morningside Healthcare
Slovenien FarmaPlus AS
FarmaPlus AS
VANCOMYCINHYDROCHLORID 1000 MG
VANCOMYCIN HYDROCHLORIDE 1000MG
INFUSIONSVÆSKE
INFUSION
Pfizer Healthcare Ireland Vancomycin Pfizer
Vancomycin Pfizer Healthcare Ireland
VANCOMYCINHYDROCHLORID 1000 MG FLASKE
VANCOMYCIN HYDROCHLORIDE 1000 mg bottle
Vanmicira
Vanycin
Grækenland Fresenius Kabi Hellas A.E. Vancomycin Kabi
Fresenius Kabi Hellas A.E.
PULVER TIL ORAL OPLØSNING, PULVER TIL INFUSIONSVÆSKE,
POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION
Ungarn Pharmacologic Kft
Pharmacologic Kft Vancocin
PULVER TIL INJEKTIONS/INFUSION-VÆSKE, OPLØSNING
SOLUTION FOR INJECTION/INFUSION
Vancomycin Mip VANCOMYCIN 1000 MG HÆTTEGLAS
Vancomycin Mip VANCOMYCIN 1000MG VIAL
Tyskland Actavis Group Ptc Ehf.
United Kingdom Actavis Group Ptc Ehf.
Litauen Mip Pharma Gmbh
Lyomark Pharma Gmbh
VANCOMYCINHYDROCHLORID 10252 MG ENHEDER
VANCOMYCIN HYDROCHLORIDE 1025.2MG UNITS
VANCOMYCIN 250 MG KAPSEL
Vancomycin Enterocaps 250 Mg Kapseln
Bulgarien Mip Pharma Gmbh ванкомицин Mip
Mip Pharma Gmbh Vancomycin Mip Pharma
Vancocin Cp VANCOMYCIN 500 MG OG 1000 MG
Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG VIAL
Pharmacodane Aps
Pharmacodane Aps Vancocin
VANCOMYCINHYDROCHLORID 500 MG
VANCOMYCIN HYDROCHLORIDE 500MG
1000 MG HÆTTEGLAS
1000 mg VIAL
Bulgarien Fresenius Kabi Bulgaria Eood ванкомицин каби
Fresenius Kabi Bulgaria Eood ванкомицин каби VANCOMYCIN 1000MG VIAL
Fresenius Kabi Limited Vancomycin Fresenius Kabi
Fresenius Kabi Nv-Sa Vancomycine Fresenius Kabi
Grækenland Generics Pharma Hellas Ltd Vancomycin Generics
Generics Pharma Hellas Ltd
Fresenius Kabi Norge As Vancomycin Fresenius Kabi
Fresenius Kabi Ab Vancomycin Fresenius Kabi
Mip Pharma Austria Gmbh Vancomycin Mip VANCOMYCIN 1000 MG HÆTTEGLAS
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL
Mip Pharma Austria Gmbh Vancomycin Mip VANCOMYCIN 500 MG HÆTTEGLAS
Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL
Hospira Uk Ltd
Hospira Uk Ltd Vanmicira
Ungarn Teva Gyógyszergyár Zrt VancomycinHuman Teva
Vancomycin-Human Teva Gyógyszergyár
Belgien Hospira Benelux Bvba Vancomycin Hospira
Hospira Benelux Bvba
Vancomycin Mip VANCOMYCIN 500 MG HÆTTEGLAS
Vancomycin Mip VANCOMYCIN 500MG VIAL
VANCOMYCIN 1000 MG OG 500 MG HÆTTEGLAS
VANCOMYCIN 500MG and 1000MG
Vancomicina VANCOMYCINHYDROCHLORID 1025,14 MG HÆTTEGLAS
VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL
PULVER TIL INFUSION INTRAVENØS ANVENDELSE
POWDER FOR INFUSION
Noridem Enterprises Ltd Vancomycin Noridem
Vancomycin Noridem Enterprises Ltd.
Bulgarien Hospira Uk Ltd ванкомицин хоспира
United Kingdom Hospira Uk Ltd Vancomycin Hydrochloride
Actavis
аквисцин
Cnp Pharma Gmbh
Cnp Pharma Gmbh Vancosan
Vancocin VANCOMYCINHYDROCHLORID 250 MG KAPSEL
VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE
Vancocin VANCOMYCIN 125 MG KAPSEL
Vancomycin Actavis VANCOMYCIN 125MG CAPSULE
VANCOMYCINHYDROCHLORID 256 MG KAPSEL
VANCOMYCIN HYDROCHLORIDE 256MG CAPSULE
Tyskland Hospira Deutschland Gmbh Vancomycin Hospira
Hospira Portugal Lda Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Vancomycin VANCOMYCINHYDROCHLORID 500 MG FLASKE
VANCOMYCIN HYDROCHLORIDE 500MG BOTTLE
Vancomycin Hydrochloride Hospira
Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Vangrotin VANCOMYCINHYDROCHLORID 500 HÆTTEGLAS
Vancomycin hydrochloride 500 Vial
Vancocin VANCOMYCIN 1 G
Vancomycine Teva VANCOMYCIN HYDROCHLORIDE 1G
INFUSIONSVÆSKE,
DIRECT INTRAVENOUS INJECTION
Det Forenede Xellia Pharmaceuticals Aps Vancomycin VANCOMYCIN 125 MG KAPSEL
Vancomycin Xellia VANCOMYCIN 125MG CAPSULE
Vancocin Cp VANCOMYCIN 250 MG KAPSEL
Vancomycin Actavis VANCOMYCIN 250MG CAPSULE
Kabi
Bvba
VANCOMYCINHYDROCHLORID 500 MG FLASKE
VANCOMYCIN Hydrochloride 500MG bottle
Vancocin VANCOMYCINHYDROCHLORID 125 MG KAPSEL
VANCOMYCIN HYDROCHLORIDE 125MG CAPSULE
Finland Mip Pharma Gmbh
Mip Pharma Austria Gmbh
512,57 MG HÆTTEGLAS INFUSIONSVÆSKE, OPLØSNING
1025.14MG VIAL FOR SOLUTION FOR INFUSION
Letland Pfizer Europe Ma Eeig Vancomycin Pfizer
Pfizer Europe Ma Eeig Vancomycin Pfizer VANCOMYCIN 500MG VIAL
Vancocin Cp VANCOMYCINHYDROCHLORID 1 G AMPUL
Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 1G BOTTLE
Vancomycin CoPharma
United Kingdom Co-Pharma Limited Vancomycin CoPharma
Vancomycin Cnp Pharma
Cnp Pharma Gmbh Vancomycin Cnp Pharma
VANCOMYCINHYDROCHLORID 1 G
VANCOMYCIN HYDROCHLORIDE 1G VIAL
OPLØSNING, PULVER TIL INFUSIONSVÆSKE, OPLØSNING
SOLUTION, POWDER FOR SOLUTION FOR INJECTION
Xellia Pharmaceuticals Aps Vancomycin Xellia
Vancomycin Xellia VANCOMYCIN
Tyskland Noridem Enterprises Ltd Vancomycin VANCOMYCIN 500 MG PULVER TIL
Actavis Group Ptc Vancomycin Actavis VANCOMYCIN 500MG POWDER FOR
VANCOMYCINHYDROCHLORID 0,5 G HÆTTEGLAS
VANCOMYCIN HYDROCHLORIDE 0.5G VIAL
Vankomicin Cnp VANCOMYCIN 1000 MG HÆTTEGLAS
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL
Vancomycin Mip VANCOMYCINHYDROCHLORID 510 MG HÆTTEGLAS
VANCOMYCIN HYDROCHLORIDE 510MG VIAL
Reig Jofré
Vancomycin Laboratorio Reig Jofré
Mip Pharma Gmbh
Mip Pharma Gmbh Vancosan
VANCOMYCINHYDROCHLORID 125 MG KAPSEL
HYDROCHLORIDE 125MG CAPSULE
Vancomycin Hydrochloride Hospira Uk
Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Vankomicin Cnp VANCOMYCIN 500 MG HÆTTEGLAS
Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL
Vancomycin VANCOMYCIN 125 MG KAPSEL, HÅRD
Vancomycin Xellia VANCOMYCIN 250MG CAPSULE, HARD ORAL USE
Vancomycin Mip VANCOMYCINHYDROCHLORID 1020 MG HÆTTEGLAS
Vancomicina Labesfal VANCOMYCIN Hydrochloride1000MG vial
Finland Xellia Pharmaceuticals Aps Vancomycin Xellia
Vancomycin Xellia Pharmaceuticals Aps
PULVER TIL OPLØSNING TIL INJEKTION
POWDER FOR SOLUTION FOR INjection
Vankomicin Lek VANCOMYCIN 1000 MG HÆTTEGLAS
Vancomycin Nrim VANCOMYCIN 1000MG VIAL
Laboratórios Normon, S.A. Vancomicina Normon
Laboratórios Normon, S.A.
Irland
Bulgaria
Xellia Pharmaceuticals Aps Vancomycin VANCOMYCIN 1000 MG PULVER TIL
Vancomycin Xellia VANCOMYCIN 1000MG VIAL
Tyskland Riemser Pharma Gmbh Vancomycin "lederle" 500
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL
Levovanox VANCOMYCIN 500 MG HÆTTEGLAS
Vancomycin Noridem VANCOMYCIN 500MG VIAL
Vancomycin Hikma
Hikma Farmacêutica Vancomycin Hikma VANCOMYCIN
Vancocin VANCOMYCIN 500 MG HÆTTEGLAS
Vancomycin Nrim VANCOMYCIN 500MG VIAL
Vancomicina Sala
Vancomicina Combino
Levovanox VANCOMYCIN 250 MG KAPSEL
Vancomycin Xellia VANCOMYCIN 250MG CAPSULE
Tyskland Riemser Pharma Gmbh Vancomycin "lederle" 1000
Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL
VANCOMYCIN 50 MG/ML PULVER TIL KONCENTRAT TIL
VANCOMYCIN 1G VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR
Tyskland Xellia Pharmaceuticals Aps VancoRatiopharm
United Kingdom Xellia Pharmaceuticals Aps
Vancomycin Ratiopharm
Vanco-Ratiopharm VANCOMYCIN HYDROCHLORIDE
Flynn Pharma Limited Vancocin VANCOMYCIN 50 MG/ML PULVER TIL KONCENTRAT TIL
Vancomycine Mylan VANCOMYCIN 50MG/ML
Dosis for børn afhænger af alderen.
The dose in children depends on their age.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neoclarityn den 15. januar 2001
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Til voksne og unge kan der anvendes en hvilken som helst form af lægemidlet.
Adults and adolescents can use any form of the medicine.
Den fuldstændige EPAR for Neoclarityn findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neoclarityn.
This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Andre oplysninger om Neoclarityn
Other information about Neoclarityn
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Neoclarityn.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neoclarityn.
Der kunne iagttages tilsvarende bivirkninger hos børn.
The side effects seen in children are similar.
Neoclarityn blev også undersøgt hos 416 patienter med urticaria.
Neoclarityn has also been studied in 416 patients with urticaria.
Neoclarityn er et lægemiddel, der indeholder det aktive stof desloratadin.
Neoclarityn is a medicine containing the active substance desloratadine.
Det aktive stof i Neoclarityn, desloratadin, er et antihistamin.
The active substance in Neoclarityn, desloratadine, is an antihistamine.
I alle undersøgelserne blev Neoclarityn effekt sammenlignet med virkningen af placebo (uvirksom behandling).
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Hvis du ønsker yderligere oplysninger om behandling med Neoclarityn, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Der blev fremlagt resultater af supplerende undersøgelser for at påvise, at sirup, oral oplysning og smeltetabletter optages i kroppen på samme måde som tabletter, og for at vise, at de kan anvendes sikkert hos børn.
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Det virker ved at blokere de receptorer, på hvilke histamin, et stof i kroppen, som forårsager allergiske symptomer, normalt fastgør sig.
It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
I de to undersøgelser af urticaria var faldet i symptomscoren efter seks ugers behandling med Neoclarityn 58 % og 67 % sammenlignet med 40 % og 33 % for patienter behandlet med placebo.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Hos voksne og unge er de hyppigste bivirkninger træthed (1,2 %), tørhed i munden (0,8 %) og hovedpine (0,6 %).
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Neoclarityn blev undersøgt i otte undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Neoclarityn må ikke anvendes til personer, som er overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.