natgillin/translations-raw huggingface dataset:
6 måneder for børn og 2 år for voksne (se nedenstående tabel).
Duration of vaccine protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
Beskyttende effekt mod kolera i forsøget i Bangladesh (per- protocol- analyse) Beskyttende effekt,% (95% CI) Voksne og børn > 6 år Børn 2- 6 år:
Protective efficacy against cholera in the Bangladesh study (per-protocol analysis) Protective efficacy,% (95% CI)
6 mdr.
6 months st
1. år 2. år
1 year 2nd year
76 (60, 85) 60 (36, 76)
76 (60, 85) 60 (36, 76)
44 (10, 65) 33 (- 23, 64)
44 (10, 65) 33 (-23, 64)
I det andet forsøg, der blev gennemført i Peru med deltagelse af rekrutter fra militæret, var den kortsigtede beskyttende effekt mod kolera efter 2 vaccinedoser 85% (95% CI:
In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy against cholera after 2 vaccine doses was 85% (95%CI:
36, 97, per- protocol - analyse).
36, 97, per-protocol analysis).
Det tredje forsøg, et feltforsøg, der blev gennemført i Peru, viste ingen beskyttende effekt
The third study, a field trial conducted in Peru, failed to show any protective efficacy against cholera during the first year.
Efter en booster- dosis 10- 12 måneder efter den primære immunisering var den beskyttende effekt i det andet år 60, 5% (95% CI:
Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI:
Den beskyttende effekt af DUKORAL mod kolera efter gentagelse med en booster- vaccination er ikke undersøgt.
Protective efficacy of DUKORAL against cholera has not been studied following repeated booster vaccination.
Immunogenicitet Der er ikke fundet nogen anerkendte immunologiske korrelater for beskyttelse mod kolera efter oral vaccination.
Immunogenicity No established immunological correlates of protection against cholera after oral vaccination have been identified.
Lokalt producerede sekretoriske IgA- antistoffer i intestina medierer sandsynligvis en beskyttende immunitet.
Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity.
Vaccinen inducerede antitoksine IgA- reaktioner i intestina hos 70- 100% af de vaccinerede personer.
The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
Vibriocide antistoffer i serum mod de bakterielle komponenter blev set hos 35- 55% af de vaccinerede personer og antitoksiske antistoffer hos 78- 87% af de vaccinerede personer.
Serum vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects and antitoxic antibodies in 78-87% of vaccinated subjects.
En booster- dosis udløste en anamnestisk reaktion, hvilket kan tyde på en immunhukommelse.
A booster dose elicited an anamnestic response indicative of an immune memory.
5. 3 Prækliniske sikkerhedsdata
7 5.3 Preclinical safety data
Suspension:
Suspension:
Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatdihydrat Natriumchlorid Vand til injektion
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Sodium chloride Water for injections
Brusegranulat:
Effervescent granules:
Natriumhydrogencarbonat Citronsyre Natriumkarbonat, vandfrit Saccharinnatrium Natriumcitrat Hindbæraroma
Sodium hydrogen carbonate Citric acid Sodium carbonate, anhydrous Saccharin sodium Sodium citrate Raspberry flavour
DUKORAL må kun blandes med det medfølgende brusegranulat, der er opløst i vand.
DUKORAL should only be mixed with the supplied effervescent granules dissolved in water.
7 Når brusegranulatet er opløst i vand, og vaccinesuspensionen er tilsat, skal blandingen drikkes inden for 2 timer.
After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Vaccinesuspensionen er i mængder á 3 ml fyldt i hætteglas (type I- glas) med gummiprop (bromobuthylgummi) og skruelåg.
The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.
Brusegranulatet er i mængder á 5, 6 g fyldt i breve med et indvendigt lag af polyester/ LD- polyethylen og et udvendigt lag af aluminium/ LD- polyethylen.
The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/ LD-polyethylene and an outer layer of aluminium/ LD-polyethylene.
1x1 dosis, 2x1 dosis, 20x1 dosis Ikke alle pakningsstørrelser er nødvendigvis markedsført.
1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Brusegranulatet skal opløses i cirka 150 ml koldt vand.
8 The effervescent granules should be dissolved in approximately 150 ml of cool water.
Hætteglasset med vaccinen skal rystes, og vaccinesuspensionen tilsættes herefter opløsningen af natriumhydrogencarbonat og blandes grundigt, så man får en farveløs, let opaliserende opløsning.
The vaccine vial should be shaken and the vaccine suspension should then be added to the sodium hydrogen carbonate solution and mixed well to obtain a colourless slightly opalescent solution.
SBL Vaccin AB S- 105 21 Stockholm Sverige
SBL Vaccin AB S-105 21 Stockholm Sweden
28. april 2004 Dato for seneste fornyelse:
28 April 2004 Date of latest renewal:
MM/ ÅÅÅÅ Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
8 BILAG II
9 ANNEX II
FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
10 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SBL Vaccin AB SE- 105 21 Stockholm Sverige
SBL Vaccin AB SE-105 21 Stockholm Sweden
UniTech BioPharma AB Storjorden 2 SE- 864 31 Matfors Sverige
UniTech BioPharma AB Storjorden 2 SE-864 31 Matfors Sweden
Indehaveren af denne markedsføringstilladelse skal underrette Europa- Kommissionen markedsføringsplanerne for det lægemiddel, der er godkendt ved denne beslutning.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Den officielle batchfrigivelse vil blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil i henhold til artikel 114 i Rådets direktiv 2001/ 83/ EØF, med ændringer.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose
12 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
LABELLING
1 dosis indeholder − 25x109 bakterier * af hver af følgende V. cholerae O1- stammer:
1 dose contains − 25x109 bacteria* of each of the following V. cholerae O1 strains:
Inaba klassisk biotype (varme - inaktiveret), Inaba El Tor biotype (formalin- inaktiveret), Ogawa klassisk biotype (varme - inaktiveret), Ogawa klassisk biotype (formalin- inaktiveret). − Rekombinant koleratoksin B- subenhed (rCTB) 1 mg.
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated). − Recombinant cholera toxin B subunit (rCTB) 1 mg.
* bakterieindhold inden inaktivering
*bacterial content prior to inactivation
3 ml suspension i et hætteglas og 5, 6 g brusegranulat i et brev.
3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
1 dosis 2x1 dosis 20x1 dosis
1 dose 2x1 dose 20x1 dose
Brugsanvisning 1.
Instructions 1.
Brusegranulatet opløses i et glas koldt vand (cirka 150 ml).
150 ml).
Halvdelen af opløsningen kasseres.
Children 2-6 years: pour away half of the solution.
Hætteglasset med vaccinen omrystes (1 hætteglas = 1 dosis).
Shake the vaccine vial (1 vial = 1 dose).
Vaccinen tilsættes i opløsningen af natriumhydrogencarbonat.
Add the vaccine to the sodium hydrogen carbonate solution.
Udløbsdato MM/ ÅÅÅÅ
EXP MM/ YYYY
SBL Vaccin AB 105 21 Stockholm, Sverige
SBL Vaccin AB 105 21 Stockholm, Sweden
EU/ 1/ 03/ 263/ 001 1 dosis EU/ 1/ 03/ 263/ 002 2x1 dosis EU/ 1/ 03/ 263/ 003 20x1 dosis
EU/ 1/ 03/ 263/ 001 1 dose EU/ 1/ 03/ 263/ 002 2x1 dose EU/ 1/ 03/ 263/ 003 20x1 dose
14 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
DUKORAL – 20x1 dosis pakning (indre emballage for 20 hætteglas med vaccine)
DUKORAL – 20x1 dose package (inner carton for 20 vaccine vials)
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Natriumhydrogencarbonat Brusegranulat
Sodium hydrogen carbonate Effervescent granules
20x5, 6 g
20 x 5.6 g
18 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
DUKORAL, etiket til hætteglas 1 dosis
DUKORAL, vial label 1 dose
EXP MM/ ÅÅÅÅ
EXP MM/ YYYY
19 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Natriumhydrogencarbonat 5, 6 g brev
Sodium hydrogen carbonate 5.6 g, sachet
SBL Vaccin AB, Sverige
SBL Vaccin AB, Sweden
21 INDLÆGSSEDDEL:
PACKAGE LEAFLET
DUKORAL suspension og brusegranulat til oral suspension Vaccine mod kolera (inaktiveret, oral).
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
Læs denne indlægsseddel grundigt, inden De begynder at bruge vaccinen.
Read all of this leaflet carefully before you start using this vaccine.
- Lægen har ordineret DUKORAL til Dem personligt.
- This vaccine has been prescribed for you.
Virkning og anvendelse 2.
What DUKORAL is and what it is used for 2.
Det skal De vide, før De begynder at bruge DUKORAL 3.
Before you use DUKORAL 3.
Sådan skal De bruge DUKORAL 4.
How to use DUKORAL 4.
Opbevaring 6.
Possible side effects 5 How to store DUKORAL 6.
VIRKNING OG ANVENDELSE
WHAT DUKORAL IS AND WHAT IT IS USED FOR
DUKORAL er en oral vaccine mod kolera, der stimulerer immunforsvaret i tarmen.
DUKORAL is an oral vaccine against cholera that stimulates the immunological defence in the gut.
Vaccinen beskytter voksne og børn fra 2- års- alderen mod kolera.
The vaccine protects adults and children from 2 years of age against cholera.
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE DUKORAL
BEFORE YOU USE DUKORAL
Brug ikke DUKORAL
Do not use DUKORAL
- hvis De er overfølsom (allergisk) over for vaccinen, et af de øvrige indholdsstoffer eller
- if you are allergic to any ingredient of the vaccine or to formaldehyde.
formaldehyd.
- if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
- Hvis De lider af akut mavesygdom eller infektion med feber (vaccinationen skal så udsættes).
Take special care with DUKORAL
Vær ekstra forsigtig med at bruge DUKORAL Fortæl det til lægen, hvis De tager et lægemiddel, der påvirker immunsystemet, eller hvis De har en sygdom i immunsystemet (f. eks. aids).
Tell your doctor if you take a medical treatment that affects the immune system or if you have a disease of the immune system (including AIDS).
Brug af anden medicin Tag ikke anden medicin fra 1 time før til 1 time efter indtagelse af vaccinen.
Using other medicines Do not take other medicine 1 hour before and 1 hour after taking the vaccine.
Brug af DUKORAL sammen med mad og drikke Undgå indtagelse af føde - og drikkevarer i 1 time inden og 1 time efter vaccination.
Using DUKORAL with food and drink Avoid food and drink 1 hour before and 1 hour after the vaccination.
Graviditet og amning Spørg Deres læge eller apoteket til råds, før De bruger nogen form for medicin.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant or are breast-feeding.
22 Trafik - og arbejdssikkerhed Der er ikke grund til at tro, at DUKORAL vil påvirke Deres evne til at føre motorkøretøj elle betjene maskiner.
Driving and using machines There are no reasons to suspect that DUKORAL will affect your ability to drive or handle machines
1, 1 g natrium pr. dosis.
23 Important information about some of the ingredients of DUKORAL DUKORAL contains approximately 1.1 g sodium per dose.
Patienter, der er på en kontrolleret natriumdiæt, skal tage højde for dette.
To be taken into consideration by patients on a controlled sodium diet.
Voksne og børn fra 6 år:
HOW TO USE DUKORAL Adults and children from 6 years of age:
Den primære vaccination er 2 doser.
The primary vaccination is 2 doses.
Doserne skal tages med et interval på 1 til 6 uger.
Doses are to be taken with an interval of 1 to 6 weeks.
Revaccination efter 2 år anbefales af hensyn til den fortsatte beskyttelse.
For continuous protection, re-vaccination is recommended after 2 years.
Hvis mindre end 2 år er forløbet siden seneste vaccination, er en enkelt dosis tilstrækkelig.
If up to 2 years have passed since the last vaccination a single dose is sufficient.
Hvis mere end 2 år er forløbet siden seneste vaccination, bør den primære vaccination (2 doser) gentages.
If more than 2 years have passed since the last vaccination, the primary vaccination (2 doses) should be repeated.
Børn fra 2 til 6 år:
Children of 2 to 6 years of age:
Den primære vaccination er 3 doser.
The primary vaccination is 3 doses.
Kun halvdelen af opløsningen med natriumhydrogencarbonat skal blandes med vaccinen.
Only half of the amount of the sodium hydrogen carbonate solution should be mixed with the vaccine.
Revaccination efter 6 måneder anbefales af hensyn til den fortsatte beskyttelse.
For continuous protection, re-vaccination is recommended after 6 months.
Hvis mere end 2 år er forløbet siden seneste vaccination, bør den primære vaccination (3 doser) gentages.
If more than 2 years have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Beskyttelse mod kolera kan forventes cirka en uge efter den primære vaccination.
Protection against cholera can be expected about 1 week after the primary vaccination is completed.
Vaccinen er en hvidlig suspension, der leveres i et enkeltdosis- hætteglas.
The vaccine is a whitish suspension supplied in a single-dose glass vial.
Hver dosis af vaccinen leveres sammen med et brev, der indeholder et hvidt brusegranulat af natriumhydrogencarbonat.
Each dose of vaccine comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate.
Granulatet skal opløses i et glas vand og blandes med vaccinen.
The granules should be dissolved in a glass of water and mixed with the vaccine.
Opløsningen af natriumhydrogencarbonat beskytter vaccinen mod mavesyren.
The sodium hydrogen carbonate solution protects the vaccine from the gastric acid.
Vaccinen skal drikkes inden for 2 timer efter opblanding med opløsningen af natriumhydrogencarbonat.
Drink the vaccine within 2 hours after mixing with the sodium hydrogen carbonate solution.
Brusegranulatet (natriumhydrogencarbonat) opløses i et glas koldt vand (cirka 150 ml).
150 ml).
DUKORAL kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, DUKORAL can cause side effects, although not everybody gets them.
Hyppigheden af de mulige bivirkninger, der er nævnt nedenfor, defineres ud fra følgende konvention: meget almindelig (forekommer hos flere end 1 ud af 10 brugere) almindelig (forekommer hos mellem 1 og 10 ud af 100 brugere) 23 ikke almindelig (forekommer hos mellem 1 og 10 ud af 1. 000 brugere) sjælden (forekommer hos mellem 1 og 10 ud af 10. 000 brugere) meget sjælden (forekommer hos færre end 1 ud af 10. 000 brugere) ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data)
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data) 24 Uncommon side effects (reported by less than 1 in a 100 but more than 1 in a 1,000 people) include: diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort, headache
Nogle af de usædvanlige bivirkninger (indberettet for mindre end 1 ud af 100 personer, men for mere end 1 ud af 1. 000 personer) er: diaré, mavepine, mavekramper, skvulpen i maven, oppustet mave, luft i maven, generelt ubehag i maven og hovedpine.
Rare side effects (reported by less than 1 in a 1,000 but more than 1 in a 10,000 people) include: high temperature, generally feeling unwell, nausea, vomiting, loss of / or poor appetite, runny nose, cough and dizziness.
Nogle af de meget sjældne bivirkninger (indberettet for mindre end 1 ud af 10. 000 personer) er: udmattethed/ træthed, kulderystelser, kraftig diaré, ledsmerter, halssmerter, nedsat smagssans, svedtendens, søvnløshed, smerter generelt, nældefeber, andre typer udslæt, influenzalignende symptomer, sløjhed, kuldskærhed, kortåndethed, prikkende paræstesi, dehydrering (tab af vand i kroppen), hævelser i ansigtet, forhøjet blodtryk, øget spytmængde, kløe samt hævelser i lymfekirtlerne.
Very rare side effects (reported by less than 1 in a 10,000 people) include: fatigue/ feeling tired, shivering, severe diarrhoea, joint pain, sore throat, reduced sense of taste, sweating, being unable to sleep, general pain, hives or nettle rash, other types of rashes, flu-like symptoms, weakness, feeling cold, breathlessness, pins and needles, dehydration (loss of water from the body), swelling of face, high blood pressure, chestiness, itching, and swelling of the lymph glands.
OPBEVARING
HOW TO STORE DUKORAL
Brug ikke DUKORAL efter den udløbsdato, der står på pakningen.
Do not use DUKORAL after the expiry date which is stated on the carton.
DUKORAL indeholder:
What DUKORAL contains
Aktive stoffer:
- The active substances are:
25x109 bakterier * af hver af følgende V. cholerae O1- stammer:
25x109 bacteria* of each of the following V. cholerae O1 strains:
Inaba klassisk biotype (varme - inaktiveret), Inaba El Tor biotype (formalin- inaktiveret), Ogawa klassisk biotype (varme - inaktiveret), Ogawa klassisk biotype (formalin- inaktiveret).
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated).
Rekombinant koleratoksin B- subenhed (rCTB) 1 mg. * bakterieindhold inden inaktivering
Recombinant cholera toxin B subunit (rCTB) 1 mg. *bacterial content prior to inactivation
-
- The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium
Øvrige indholdsstoffer i vaccinesuspensionen: natriumdihydrogenphosphat, dinatriumhydrogenphosphat, natriumchlorid og vand til injektion.
hydrogen phosphate, sodium chloride and water for injections.
-
- The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate,
Brusegranulatet indeholder natriumhydrogencarbonat, citronsyre, natriumcarbonat, saccharinnatrium, natriumcitrat og hindbæraroma.
saccharin sodium, sodium citrate and raspberry flavour.
Udseende og pakningsstørrelser DUKORAL leveres som en suspension og brusegranulat til oral suspension.
What DUKORAL looks like and contents of the pack DUKORAL is presented as a suspension and effervescent granules for oral suspension.
Vaccinen er en hvidlig suspension i et hætteglas.
The vaccine is a whitish suspension supplied in a vial.
Natriumhydrogencarbonatet er et hvidt brusegranulat med hindbæraroma i et brev.
The sodium hydrogen carbonate is white effervescent granules with a raspberry flavour supplied in a sachet.
24 DUKORAL fås i pakninger med 1, 2 og 20 doser.
DUKORAL is available in packs of 1, 2 and 20 doses.
Indehaver af markedsføringstilladelsen og fremstiller SBL Vaccin AB, 105 21 Stockholm, Sverige.
Marketing Authorisation Holder and Manufacturer SBL Vaccin AB, 105 21 Stockholm, Sweden.
Denne indlægsseddel blev senest godkendt MM/ ÅÅÅÅ
This leaflet was last approved in MM/ YYYY
EU/ H/ C/ 001007/ 0000/ 001
EU/ 1/ 08/ 471/ 001
Blisterpakning (PVC/ PE/ PCTFE/ alu)
blister (PVC/ PE/ PCTFE/ alu)
EU/ H/ C/ 001007/ 0000/ 002
EU/ 1/ 08/ 471/ 002
EU/ H/ C/ 001007/ 0000/ 003
EU/ 1/ 08/ 471/ 003
EU/ H/ C/ 001007/ 0000/ 004
EU/ 1/ 08/ 471/ 004
EU/ H/ C/ 001007/ 0000/ 005
EU/ 1/ 08/ 471/ 005
EU/ H/ C/ 001007/ 0000/ 006
EU/ 1/ 08/ 471/ 006
EU/ H/ C/ 001007/ 0000/ 007
EU/ 1/ 08/ 471/ 007
EU/ H/ C/ 001007/ 0000/ 008
EU/ 1/ 08/ 471/ 008
EU/ H/ C/ 001007/ 0000/ 009
EU/ 1/ 08/ 471/ 009
EU/ H/ C/ 001007/ 0000/ 010
EU/ 1/ 08/ 471/ 010
EU/ H/ C/ 001007/ 0000/ 011
EU/ 1/ 08/ 471/ 011
EU/ H/ C/ 001007/ 0000/ 012
EU/ 1/ 08/ 471/ 012
Blisterpakning (PVC/ PE/ PCTFE, alu)
blister (PVC/ PE/ PCTFE/ alu)
DULOXETINE BOEHRINGER INGELHEIM 40 mg hårde enterokapsler.
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules.
5. 1).
DULOXETINE BOEHRINGER INGELHEIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
Den anbefalede dosering af DULOXETINE BOEHRINGER INGELHEIM er 40 mg to gange daglig uden hensyntagen til måltider.
The recommended dose of DULOXETINE BOEHRINGER INGELHEIM is 40 mg twice daily without regard to meals.
Der er dog begrænset data tilgængelig til at understøtte effekten af DULOXETINE BOEHRINGER INGELHEIM 20 mg to gange daglig.
However, limited data are available to support the efficacy of DULOXETINE BOEHRINGER INGELHEIM 20 mg twice daily.
Effekten af DULOXETINE BOEHRINGER INGELHEIM er ikke blevet undersøgt i mere end 3 måneder i placebokontrollerede studier.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Ved at kombinere DULOXETINE BOEHRINGER INGELHEIM med bækkenbundstræning kan der muligvis opnås en bedre effekt end ved hver af de to behandlinger alene.
Combining DULOXETINE BOEHRINGER INGELHEIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Det medicinske respons bør evalueres efter 2 måneders behandling.
The medicinal product response should be evaluated after 2 months ’ of treatment.
2 Den terapeutiske effekt bør med jævne mellemrum vurderes (mindst hver tredje måned).
2 The therapeutic benefit should regularly (at least every three months) be reassessed.
4. 3).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
4. 3).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
4. 4 og 4. 8).
When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
4. 5).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
4. 5).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
4. 4 og 4. 8).
The initiation of treatment with DULOXETINE BOEHRINGER INGELHEIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Mani og krampeanfald DULOXETINE BOEHRINGER INGELHEIM skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/ eller krampeanfald.
Mania and Seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
4. 5)
Use with antidepressants The use of DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).