natgillin/translations-raw huggingface dataset:
8 The effervescent granules should be dissolved in approximately 150 ml of cool water.
Šumeča zrnca je treba raztopiti v približno 150 ml hladne vode.
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.
Viale s cepivom se ne smejo stresati, suspenzijo cepiva pa je treba dodati raztopini natrijevega hidrogenkarbonata in dobro premešati, da bi dobili brezbarvno, rahlo opalescentno raztopino.
SBL Vaccin AB S-105 21 Stockholm Sweden
SBL Vaccin AB S- 105 21 Stockholm Švedska
28 April 2004 Date of latest renewal:
28. april 2008 Datum zadnjega podaljšanja:
9 ANNEX II
8 DODATEK II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
10 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev biološke zdravilne učinkovin
SBL Vaccin AB SE-105 21 Stockholm Sweden
SBL Vaccin AB SE- 105 21 Stockholm Švedska
UniTech BioPharma AB Storjorden 2 SE-864 31 Matfors Sweden
UniTech BioPharma AB Storjorden 2 SE- 864 31 Matfors Švedska
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
Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
LABELLING
12 PODATKI NA ZUNANJI OVOJNINI
DUKORAL – 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve)
DUKORAL – pakiranje po 1 odmerek, pakiranje 2x1 odmerek, pakiranje 20x1 odmerek (zunanji ovoj)
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
DUKORAL suspenzija in šumeča zrnca za peroralno suspenzijo Cepivo proti koleri (inaktivirano peroralno).
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.
1 odmerek vsebuje − 25x109 bakterij * vsake od naslednjih sevov bakterije V. cholerae O1: klasični biotip Inaba (inaktiviran s toploto), biotip Inaba El Tor (inaktiviran s formalinom), klasični biotip Ogawa (inaktiviran s toploto), klasični biotip Ogawa (inaktiviran s formalinom). − Rekombinantno podenoto toksina kolera B (rCTB).
*bacterial content prior to inactivation
* količina bakterij pred inaktivacijo
3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
3 ml suspenzije v viali in 5, 6 g šumečih zrnc v blazinici.
1 dose 2x1 dose 20x1 dose
1 odmerek 2 x 1 odmerek 20 x 1 odmerek
Instructions 1.
Navodila 1.
150 ml).
Šumeča zrnca raztopite v kozarcu hladne vode (približno 150 ml).
Children 2-6 years: pour away half of the solution.
Otroci, stari 2– 6 let: odlijte stran pol raztopine.
Shake the vaccine vial (1 vial = 1 dose).
Pretresite vialo s cepivom (1 viala = 1 odmerek).
Add the vaccine to the sodium hydrogen carbonate solution.
Dodajte cepivo raztopini natrijevega hidrogenkarbonata.
EXP MM/ YYYY
Uporabno do MM/ LLLL
SBL Vaccin AB 105 21 Stockholm, Sweden
SBL Vaccin AB 105 21 Stockholm, Švedska
EU/ 1/ 03/ 263/ 001 1 dose EU/ 1/ 03/ 263/ 002 2x1 dose EU/ 1/ 03/ 263/ 003 20x1 dose
EU/ 1/ 03/ 263/ 001 1 odmerek EU/ 1/ 03/ 263/ 002 2 x 1 odmerek EU/ 1/ 03/ 263/ 003 20 x 1 odmerek
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
14 PODATKI NA ZUNANJI OVOJNINI
DUKORAL – 20x1 dose package (inner carton for 20 vaccine vials)
DUKORAL – pakiranje 20x1 odmerek (stična ovojnina za 20 vial s cepivom)
DUKORAL suspension Cholera vaccine (inactivated, oral)
DUKORAL supenzija Cepivo proti koleri (inaktivirano peroralno).
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.
1 odmerek vsebuje − 25x109 bakterij * vsake od naslednjih sevov bakterije V. cholerae O1: klasični biotip Inaba (inaktiviran s toploto), biotip Inaba El Tor (inaktiviran s formalinom), klasični biotip Ogawa (inaktiviran s toploto), klasični biotip Ogawa (inaktiviran s formalinom) − rekombinantno podenoto toksina kolera B (rCTB)
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
16 PODATKI NA ZUNANJI OVOJNINI
DUKORAL – 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
DUKORAL – pakiranje 20x1 odmerek (stična ovojnina za 20 blazinic z natrijevim hidrogenkarbonatom)
Sodium hydrogen carbonate Effervescent granules
Natrijev hidrogenkarbonat Šumeča zrnca
To be used with DUKORAL.
Za uporabo z DUKORALom.
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
DUKORAL, vial label 1 dose
DUKORAL, nalepka za vialo - 1 odmerek
DUKORAL suspension Oral use.
DUKORAL suspenzija Peroralna uporaba.
EXP MM/ YYYY
EXP MM/ LLLL
Sodium hydrogen carbonate 5.6 g, sachet
natrijev hidrogenkarbonat 5, 6 g, blazinica
Sodium hydrogen carbonate effervescent granules Oral use.
Šumeča zrnca natrijevega hidrogenkarbonata Peroralna uporaba.
SBL Vaccin AB, Sweden
SBL Vaccin AB, Švedska
PACKAGE LEAFLET
21 NAVODILO ZA UPORABO
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
DUKORAL suspenzija in šumeča zrnca za peroralno suspenzijo Cepivo proti koleri (inaktivirano peroralno)
Read all of this leaflet carefully before you start using this vaccine.
Pred uporabo cepiva natančno preberite navodilo!
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če kateri koli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What DUKORAL is and what it is used for 2.
Kaj je zdravilo DUKORAL in za kaj ga uporabljamo 2.
Before you use DUKORAL 3.
Kaj morate vedeti, preden boste uporabili zdravilo DUKORAL 3.
How to use DUKORAL 4.
Kako uporabljati zdravilo DUKORAL 4.
Possible side effects 5 How to store DUKORAL 6.
Shranjevanje zdravila DUKORAL 6.
1.
DUKORAL 1.
WHAT DUKORAL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO DUKORAL IN ZA KAJ GA UPORABLJAMO
DUKORAL is an oral vaccine against cholera that stimulates the immunological defence in the gut.
DUKORAL je peroralno cepivo proti koleri, ki spodbuja imunski odziv v črevesu.
The vaccine protects adults and children from 2 years of age against cholera.
DUKORAL
BEFORE YOU USE DUKORAL
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO DUKORAL
Do not use DUKORAL
Ne uporabljajte zdravila DUKORAL:
- if you are allergic to any ingredient of the vaccine or to formaldehyde.
- če ste alergični na katerokoli sestavino cepiva ali na formaldehid,
- if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
- če imate akutno trebušno bolezen ali okužbo z vročino (cepljenje morate prestaviti).
Take special care with DUKORAL
Bodite posebno pozorni pri uporabi zdravila DUKORAL
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).
Povejte zdravniku, če ste deležni zdravljenja, ki vpliva na imunski sistem, ali če imate bolezen imunskega sistema (vključno z aidsom).
Using other medicines Do not take other medicine 1 hour before and 1 hour after taking the vaccine.
Uporaba drugih zdravil Eno uro pred jemanjem cepiva in eno uro po tem ne jemljite drugih zdravil.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta
Using DUKORAL with food and drink Avoid food and drink 1 hour before and 1 hour after the vaccination.
Uporaba zdravila DUKORAL skupaj s hrano in pijačo 1 uro pred cepljenjem in 1 uro po njem se izogibajte hrani in pijači.
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.
Nosečnost in dojenje Povejte zdravniku, če ste noseči, mislite, da bi lahko bili noseči, načrtujete nosečnost, ali če dojite.
Your doctor will decide if you should receive the vaccine DUKORAL ’
Zdravnik se bo odločil, ali lahko vzamete cepivo DUKORAL.
Driving and using machines There are no reasons to suspect that DUKORAL will affect your ability to drive or handle machines
22 Vpliv na sposobnost upravljanja vozil in strojev Ni razlogov za sum, da zdravilo DUKORAL vpliva na sposobnost vožnje ali upravljanja s stroji.
23 Important information about some of the ingredients of DUKORAL DUKORAL contains approximately 1.1 g sodium per dose.
Pomembne informacije o nekaterih sestavinah zdravila DUKORAL Zdravilo DUKORAL vsebuje približno 1, 1 g natrija.
HOW TO USE DUKORAL Adults and children from 6 years of age:
Odrasli in otroci, starejši od 6 let:
The primary vaccination is 2 doses.
Primarno cepljenje obsega 2 odmerka.
Doses are to be taken with an interval of 1 to 6 weeks.
Odmerka morate vzeti v presledkih od 1 do 6 tednov.
For continuous protection, re-vaccination is recommended after 2 years.
Za dolgotrajno zaščito je priporočeno ponovno cepljenje po 2 letih.
If up to 2 years have passed since the last vaccination a single dose is sufficient.
Če je od zadnjega cepljenja preteklo manj kot 2 leti, zadostuje en odmerek.
If more than 2 years have passed since the last vaccination, the primary vaccination (2 doses) should be repeated.
Če je od zadnjega cepljenja preteklo več kot 2 leti, morate ponoviti primarno cepljenje (2 odmerka).
Children of 2 to 6 years of age:
Otroci, stari od 2 do 6 let:
The primary vaccination is 3 doses.
Primarno cepljenje obsega 3 odmerke.
Only half of the amount of the sodium hydrogen carbonate solution should be mixed with the vaccine.
S cepivom je treba zmešati samo polovico raztopine natrijevega hidrogenkarbonata.
Doses are to be taken with an interval of 1 to 6 weeks.
Odmerke morate vzeti v presledkih od 1 do 6 tednov.
For continuous protection, re-vaccination is recommended after 6 months.
Za dolgotrajno zaščito je priporočeno ponovno cepljenje po 6 mesecih.
If more than 2 years have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Če je od zadnjega cepljenja preteklo več kot 2 leti, morate ponoviti primarno cepljenje (3 odmerki).
Protection against cholera can be expected about 1 week after the primary vaccination is completed.
Zaščito proti koleri lahko pričakujete približno 1 teden po končanem primarnem cepljenju.
The vaccine is a whitish suspension supplied in a single-dose glass vial.
Cepivo je belkasta suspenzija, ki je na voljo v vialah z enim odmerkom.
The granules should be dissolved in a glass of water and mixed with the vaccine.
Zrnca je treba raztopiti v kozarcu vode in zmešati s cepivom.
The sodium hydrogen carbonate solution protects the vaccine from the gastric acid.
Raztopina natrijevega hidrogenkarbonata ščiti cepivo pred želodčno kislino.
Drink the vaccine within 2 hours after mixing with the sodium hydrogen carbonate solution.
Cepivo spijte najpozneje v 2 urah po mešanju z raztopino natrijevega hidrogenkarbonata.
150 ml).
Šumeča zrnca (natrijev hidrogenkarbonat) raztopite v kozarcu hladne vode (približno 150 ml).
Children 2-6 years: pour away half of the solution.
Otroci 2- 6 let: odlijte stran pol raztopine
Like all medicines, DUKORAL can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo DUKORAL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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
Pogostnost spodaj navedenih neželenih učinkov je razvrščena na naslednji način: zelo pogosti (pojavijo se pri več kot enem uporabniku od 10), pogosti (pojavijo se pri 1 do 10 uporabnikih od 100),
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.
Med občasne neželene učinke (o katerih poročajo pri manj kot 1 osebi od 100 in več kot 1 osebi od 1. 000) sodijo: driska, bolečine v trebuhu, krči v trebuhu, klokotanje v trebuhu, napenjanje v trebuhu, vetrovi in splošen neprijeten občutek v trebuhu, glavobol.
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.
Med zelo redke neželene učinke (o katerih poročajo pri manj kot 1 osebi od 10. 000) sodijo: utrujenost/ občutek utrujenosti, drhtenje, huda driska, bolečine v sklepih, boleče grlo, zmanjšan čut okusa, potenje, nespečnost, splošne bolečine, koprivnica, druge vrste izpuščajev, simptomi, podobni gripi, šibkost, mrazenje, zasoplost, mravljinčenje, dehidracija (izguba vode iz telesa), otekanje obraza, povišan krvni tlak, oteženo dihanje, srbenje in otekanje bezgavk.
HOW TO STORE DUKORAL
SHRANJEVANJE ZDRAVILA DUKORAL
Do not use DUKORAL after the expiry date which is stated on the carton.
Zdravila DUKORAL ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Medicines should not be disposed of via wastewater or household waste.
DUKORALZdravil ne smete odvreči v odpadne vode ali gospodinjske odpadke.
- The active substances are:
Kaj vsebuje zdravilo DUKORAL Zdravilne učinkovine so:
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated).
25x109 bakterij * vsake od naslednjih sevov bakterije V. cholerae O1: klasični biotip Inaba (inaktiviran s toploto), biotip Inaba El Tor (inaktiviran s formalinom), klasični biotip Ogawa (inaktiviran s toploto), klasični biotip Ogawa (inaktiviran s formalinom).
Recombinant cholera toxin B subunit (rCTB) 1 mg. *bacterial content prior to inactivation
1 mg rekombinantne podenote toksina kolera B (rCTB). * količina bakterij pred inaktivacijo
- The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium
- Pomožne snovi v suspenziji za cepljenje so natrijev hidrogenfosfat, dinatrijev hidrogenfosfat,
hydrogen phosphate, sodium chloride and water for injections.
natrijev klorid in voda za injekcije.
- The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate,
- Šumeča zrnca vsebujejo natrijev hidrogenkarbonat, citronsko kislino, natrijev karbonat, natrij
saccharin sodium, sodium citrate and raspberry flavour.
saharinat, natrijev citrat in aromo maline.
What DUKORAL looks like and contents of the pack DUKORAL is presented as a suspension and effervescent granules for oral suspension.
Izgled zdravila DUKORAL in vsebina pakiranja Zdravilo DUKORAL je na voljo kot suspenzija in šumeča zrnca za peroralno suspenzijo.
The vaccine is a whitish suspension supplied in a vial.
Cepivo je belkasta suspenzija, ki je na voljo v vialah.
The sodium hydrogen carbonate is white effervescent granules with a raspberry flavour supplied in a sachet.
Natrijev hidrogenkarbonat je v obliki belih šumečih zrnc, z okusom po malinah, pakiranih v blazinice.
DUKORAL is available in packs of 1, 2 and 20 doses.
Zdravilo DUKORAL je na voljo v pakiranjih po 1, 2 in 20 odmerkov.
Marketing Authorisation Holder and Manufacturer SBL Vaccin AB, 105 21 Stockholm, Sweden.
24 Imetnik dovoljenja za promet z zdravilom in izdelovalec SBL Vaccin AB, 105 21 Stockholm, Švedska.
Duloxetine Boehringer Ingelheim is a medicine containing the active substance duloxetine.
Duloxetine Boehringer Ingelheim je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
It is available as gastroresistant capsules (blue:
Na voljo je v obliki gastrorezistentnih kapsul (modre:
20 mg; white and blue:
20 mg; bele in modre:
30 mg; orange:
30 mg; oranžne:
40 mg; green and blue:
40 mg; zelene in modre:
This prevents the active substance being destroyed by the acid in the stomach.
„ Gastrorezistentne “ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se v njem razgradila, dokler ne doseže črevesja.
Duloxetine Boehringer Ingelheim is used to treat: • moderate to severe stress urinary incontinence (SUI) in women.
Zdravilo Duloxetine Boehringer Ingelheim se uporablja za zdravljenje: • zmerne do hude stresne urinske inkontinence (SUI) pri ženskah.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising. • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Stresna urinska inkontinenca je nenadzorovano uhajanje urina med telesnim naporom, kašljanjem, smejanjem, kihanjem, dviganjem ali telesno vadbo; • bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
The dose should be reduced gradually when stopping treatment.
Zdravilo se ne sme uporabljati pri bolnikih, ki imajo
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. določene težave z jetri ali hude težave z ledvicami.
It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da preprečuje ponovni prevzem živčnih prenašalcev 5- hidroksitripamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjači.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno komunikacijo med celicami.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Delovanje duloksetina pri stresni urinski inkontinenci ni povsem jasno, vendar se domneva, da duloksetin s povečevanjem ravni 5- hidroksitripamina in noradrenalina na raven v živcih, ki nadzorujejo mišice sečnice (izvodila iz sečnega mehurja navzven), okrepi stisk mišic zapiralk sečnice med shranjevanjem urina.
For the treatment of SUI, Duloxetine Boehringer Ingelheim has been studied in a total of 2,850 women.
Pri zdravljenju stresne urinske inkontinence so zdravilo Duloxetine Boehringer Ingelheim preučevali pri skupno 2850 ženskah.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Duloxetine Boehringer Ingelheim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
V vseh štirih glavnih študijah, ki so vključevale 1913 žensk in so trajale 12 tednov, so zdravilo Duloxetine Boehringer Ingelheim (večinoma v odmerku 40 mg dvakrat na dan) primerjali s placebom (zdravilom brez zdravilne učinkovine).
For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Pri zdravljenju bolečine diabetične nevropatije so zdravilo Duloxetine Boehringer Ingelheim preučevali v dveh 12- tedenskih študijah pri 809 odraslih bolnikih s sladkorno boleznijo, ki so imeli vsaj šest mesecev bolečine vsak dan.
The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Glavno merilo učinkovitosti je bila sprememba resnosti bolečine vsak teden, kot so jo vsakodnevno v svojih dnevnikih zabeležili bolniki na podlagi 11- točkovne lestvice.
The IEF decreased by 52% in the Duloxetine Boehringer Ingelheim group, compared with a decrease of 33% in the placebo-treated group.
Pogostnost inkontinenčnih epizod se je v skupini bolnic, ki so jemale zdravilo Duloxetine Boehringer Ingelheim, zmanjšala za 52% v primerjavi s 33- odstotnim zmanjšanjem v skupini bolnic, ki so prejemale placebo.
The I-QOL questionnaire scores were also improved in the Duloxetine Boehringer Ingelheim group compared with the placebo group.
V skupini bolnic, ki so prejemale zdravilo Duloxetine Boehringer Ingelheim, se je izboljšal tudi rezultat po vprašalniku I- QOL v primerjavi s skupino, ki je prejemala placebo.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Duloxetine Boehringer Ingelheim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
V obeh študijah so zmanjšanje bolečine opazili od prvega tedna zdravljenja dalje vse do 12. tedna zdravljenja, pri čemer so rezultati glede bolnikov, ki so prejemali zdravilo Duloxetine Boehringer Ingelheim, bili za 1, 17 do 1, 45 točke nižji od rezultatov, zabeleženih pri bolnikih, ki so jemali placebo.
The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), nausea and dry mouth.
Najpogostejši neželeni učinki pri zdravljenju bolečine diabetične nevropatije (opaženi pri več kot 1 bolniku od 10) so glavobol, somnolenca 2/ 3 (zaspanost), slabost in suha usta.
Duloxetine Boehringer Ingelheim should not be used in patients with certain types of liver disease or with severe kidney disease.
Zdravila Duloxetine Boehringer Ingelheim ne smejo uporabljati bolniki z določenimi vrstami obolenj jeter ali s hudim obolenjem ledvic.
Duloxetine Boehringer Ingelheim should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Zdravilo Duloxetine Boehringer Ingelheim se ne sme uporabljati sočasno z zaviralci monoaminoksidaze (skupino zdravil proti depresiji), fluvoksaminom (drugo vrsto zdravila proti depresiji) ali ciprofloksacinom ali enoksacinom (vrstama antibiotikov).
Treatment should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Zdravljenje se ne sme uvesti pri bolnikih z nenadzorovanim visokim tlakom zaradi tveganja za hipertenzivno krizo (nenadno nevarno povišanje krvnega tlaka).
2/ 3 Why has Duloxetine Boehringer Ingelheim been approved?
Zakaj je bilo zdravilo Duloxetine Boehringer Ingelheim odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim’ s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Duloxetine Boehringer Ingelheim pri zdravljenju zmerne do hude stresne urinske inkontinence in bolečine diabetične periferne nevropatije pri odraslih večje od z njim povezanih tveganj.