natgillin/translations-raw huggingface dataset:
Corbilta 125 mg/31,25 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter). 
Corbilta 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Corbilta indeholder saccharose (1,89 mg/tablet). 
Corbilta contains sucrose (1.89 mg/tablet).
Corbilta 75 mg/18,75 mg/200 mg: Lyse brunrøde, ovale, filmovertrukne tabletter mærket med ”LCE 75” på den ene side. 
Corbilta 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Corbilta indeholder saccharose (2,3 mg/tablet). 
Corbilta contains sucrose (2.3 mg/tablet).
Corbilta 175 mg/43,75 mg/200 mg: Lyse brunrøde, ovale, filmovertrukne tabletter uden delekærv mærket med ”LCE 175” på den ene side. 
Corbilta 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Corbilta 200 mg/50 mg/200 mg tabletter findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter). 
Corbilta 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
- Hver Corbilta 125 mg/31,25 mg/200 mg tablet indeholder 125 mg levodopa, 31,25 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Corbilta 175 mg/43,75 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter). 
Corbilta 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Det skal du vide, før du begynder at tage Corbilta Sådan skal du tage Corbilta Bivirkninger 
What Corbilta is and what it is used for What you need to know before you take Corbilta How to take Corbilta
- Hver Corbilta 175 mg/43,75 mg/200 mg tablet indeholder 175 mg levodopa, 43,75 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Corbilta 200 mg/50 mg/200 mg tabletter: Mørk brunrøde, ovale filmovertrukne tabletter uden delekærv mærket med ”LCE 200” på den ene side. 
Corbilta 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Corbilta 100 mg/25 mg/200 mg: Brun- eller grårøde, ovale filmovertrukne tabletter uden delekærv mærket med ”LCE 100” på den ene side. 
Corbilta 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
- Hver Corbilta 150 mg/37,5 mg/200 mg tablet indeholder 150 mg levodopa, 37,5 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
- Hver Corbilta 50 mg/12,5 mg/200 mg tablet indeholder 50 mg levodopa, 12,5 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
- Hver Corbilta 100 mg/25 mg/200 mg tablet indeholder 100 mg levodopa, 25 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Corbilta indeholder saccharose (1,9 mg/tablet). 
Corbilta contains sucrose (1.9 mg/tablet).
- Hver Corbilta 200 mg/50 mg/200 mg tablet indeholder 200 mg levodopa, 50 mg carbidopa og 200 mg entacapon. 
- Each Corbilta 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Corbilta 75 mg/18,75 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta indeholder saccharose (1,2 mg/tablet). 
Corbilta contains sucrose (1.2 mg/tablet).
Corbilta indeholder saccharose (1,6 mg/tablet). 
Corbilta contains sucrose (1.6 mg/tablet).
- Hver Corbilta 75 mg/18,75 mg/200 mg tablet indeholder 75 mg levodopa, 18,75 mg carbidopa og 
- Each Corbilta 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
EU/1/13/859/007 10 filmovertrukne tabletter EU/1/13/859/008 30 filmovertrukne tabletter EU/1/13/859/009 100 filmovertrukne tabletter EU/1/13/859/010 130 filmovertrukne tabletter EU/1/13/859/011 175 filmovertrukne tabletter 
EU/1/13/859/007 10 film-coated tablets EU/1/13/859/008 30 film-coated tablets EU/1/13/859/009 100 film-coated tablets EU/1/13/859/010 130 film-coated tablets EU/1/13/859/011 175 film-coated tablets
Corbilta indeholder saccharose (1,4 mg/tablet). 
Corbilta contains sucrose (1.4 mg/tablet).
EU/1/13/859/023 10 filmovertrukne tabletter EU/1/13/859/024 30 filmovertrukne tabletter EU/1/13/859/025 100 filmovertrukne tabletter EU/1/13/859/026 130 filmovertrukne tabletter EU/1/13/859/027 175 filmovertrukne tabletter EU/1/13/859/028 250 filmovertrukne tabletter 
EU/1/13/859/023 10 film-coated tablets EU/1/13/859/024 30 film-coated tablets EU/1/13/859/025 100 film-coated tablets EU/1/13/859/026 130 film-coated tablets EU/1/13/859/027 175 film-coated tablets EU/1/13/859/028 250 film-coated tablets
EU/1/13/859/001 10 filmovertrukne tabletter EU/1/13/859/002 30 filmovertrukne tabletter EU/1/13/859/003 100 filmovertrukne tabletter EU/1/13/859/004 130 filmovertrukne tabletter EU/1/13/859/005 175 filmovertrukne tabletter EU/1/13/859/006 250 filmovertrukne tabletter 
EU/1/13/859/001 10 film-coated tablets EU/1/13/859/002 30 film-coated tablets EU/1/13/859/003 100 film-coated tablets EU/1/13/859/004 130 film-coated tablets EU/1/13/859/005 175 film-coated tablets EU/1/13/859/006 250 film-coated tablets
Hvis du under behandling med Corbilta bemærker følgende symptomer, skal du kontakte din læge øjeblikkeligt: 
If you have accidentally taken more Corbilta tablets than you should, talk to your doctor or pharmacist immediately.
EU/1/13/859/034 10 filmovertrukne tabletter EU/1/13/859/035 30 filmovertrukne tabletter EU/1/13/859/036 100 filmovertrukne tabletter EU/1/13/859/037 130 filmovertrukne tabletter EU/1/13/859/038 175 filmovertrukne tabletter 
EU/1/13/859/034 10 film-coated tablets EU/1/13/859/035 30 film-coated tablets EU/1/13/859/036 100 film-coated tablets EU/1/13/859/037 130 film-coated tablets EU/1/13/859/038 175 film-coated tablets
EU/1/13/859/018 10 filmovertrukne tabletter EU/1/13/859/019 30 filmovertrukne tabletter EU/1/13/859/020 100 filmovertrukne tabletter EU/1/13/859/021 130 filmovertrukne tabletter EU/1/13/859/022 175 filmovertrukne tabletter 
EU/1/13/859/018 10 film-coated tablets EU/1/13/859/019 30 film-coated tablets EU/1/13/859/020 100 film-coated tablets EU/1/13/859/021 130 film-coated tablets EU/1/13/859/022 175 film-coated tablets
Corbilta 175 mg/43,75 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon 
Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
EU/1/13/859/029 10 filmovertrukne tabletter EU/1/13/859/030 30 filmovertrukne tabletter EU/1/13/859/031 100 filmovertrukne tabletter EU/1/13/859/032 130 filmovertrukne tabletter EU/1/13/859/033 175 filmovertrukne tabletter 
EU/1/13/859/029 10 film-coated tablets EU/1/13/859/030 30 film-coated tablets EU/1/13/859/031 100 film-coated tablets EU/1/13/859/032 130 film-coated tablets EU/1/13/859/033 175 film-coated tablets
Corbilta 150 mg/37,5 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 125 mg/31,25 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 50 mg/12,5 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 50 mg/12,5 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon 
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
EU/1/13/859/012 10 filmovertrukne tabletter EU/1/13/859/013 30 filmovertrukne tabletter EU/1/13/859/014 100 filmovertrukne tabletter EU/1/13/859/015 130 filmovertrukne tabletter EU/1/13/859/016 175 filmovertrukne tabletter EU/1/13/859/017 250 filmovertrukne tabletter 
EU/1/13/859/012 10 film-coated tablets EU/1/13/859/013 30 film-coated tablets EU/1/13/859/014 100 film-coated tablets EU/1/13/859/015 130 film-coated tablets EU/1/13/859/016 175 film-coated tablets EU/1/13/859/017 250 film-coated tablets
Corbilta 100 mg/25 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon 
Corbilta 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 100 mg/25 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 200 mg/50 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon 
Corbilta 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 200 mg/50 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon 
Corbilta 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
- Hvis du tager Corbilta 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg. 
- If you are taking Corbilta 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
Corbilta 150 mg/37,5 mg/200 mg filmovertrukne tabletter. 
Ten tablets of Corbilta 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protelos den 21. september 2004. 
The European Commission granted a marketing authorisation valid throughout the European Union for Protelos on 21 September 2004.
Andre oplysninger om Protelos 
Other information about Protelos
Den fuldstændige EPAR for Protelos findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Protelos 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 Protelos. 
This is a summary of the European public assessment report (EPAR) for Protelos.
Protelos bør tages mindst to timer efter et måltid, mælk, mælkeprodukter eller kalciumtilskud, helst ved sengetid. 
Protelos should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Der er udarbejdet en risikostyringsplan for at sikre, at Protelos anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Protelos is used as safely as possible.
Dette viste, at risikoen for knoglebrud er mindsket. 
This showed that the risk of breaking a bone is reduced.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Protelos? 
What measures are being taken to ensure the safe and effective use of Protelos?
Protelos blev anvendt i to store undersøgelser hos næsten 7 000 ældre kvinder. 
Protelos has been studied in almost 7,000 elderly women in two large studies.
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 Protelos. 
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 Protelos.
Virksomheden gennemfører også en undersøgelse med henblik på evaluering af de foranstaltninger, der er truffet for at minimere risikoen for hjerte- og kredsløbsproblemer. 
The company will also conduct a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Hvilken risiko er der forbundet med Protelos? 
What is the risk associated with Protelos?
Hvis du ønsker yderligere oplysninger om behandling med Protelos, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Protelos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Som helhed var resultaterne af den anden undersøgelse i sig selv utilstrækkelige til at påvise en gavnlig virkning af Protelos til forebyggelse af knoglebrud. 
Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Protelos in preventing bone breaks.
Protelos er et lægemiddel, der indeholder det aktive stof strontiumranelat. 
Protelos is a medicine that contains the active substance strontium ranelate.
Protelos er beregnet til langtidsbehandling. 
Protelos is intended for long-term use.
CHMP besluttede, at fordelene ved Protelos opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse. 
The CHMP decided that Protelos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvorfor blev Protelos godkendt? 
Why has Protelos been approved?
De hyppigste bivirkninger ved Protelos (som kan optræde hos mere end 1 ud af 10 patienter) er overfølsomhedsreaktioner på huden (udslæt, kløe, urticaria (kløende udslæt) og hævelse under huden (angioødem)) og muskel-, knogle- og ledsmerter. 
The most common side effects with Protelos (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
For at reducere risikoen for hjertetilfælde må Protelos heller ikke anvendes til patienter med højt blodtryk, som ikke er tilstrækkelig kontrolleret, eller til patienter, som har eller har haft et af følgende problemer: 
In order to reduce the risk of heart attack, Protelos must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Protelos må ikke anvendes til patienter, som har eller har haft en venøs tromboemboli (problemer som følge af dannelse af blodpropper i venerne såsom i ben eller lunger). 
Protelos must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Der udsendes desuden oplysningsmateriale til patienter og sundhedspersoner, som forventes at ordinere Protelos, for at gøre opmærksom på risikoen for hjerte- og kredsløbsproblemer med lægemidlet og behovet for regelmæssig kontrol. 
In addition, education materials are sent to patients and healthcare professionals prescribing Protelos reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Når man ser på resultaterne af de to undersøgelser under et, udviklede færre kvinder i Protelosgruppen brud et andet sted end på rygsøjlen (inklusive hoften) end i placebogruppen (331 ud af 3 295 for Protelos, sammenlignet med 389 ud af 3 256 for placebo). 
When looking at results of the two studies taken together, fewer women in the Protelos group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Protelos compared with 389 out of 3,256 for placebo).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Protelos, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protelos, including the appropriate precautions to be followed by healthcare professionals and patients.
Protelos blev også sammenlignet med placebo i en hovedundersøgelse af 261 mandlige patienter med forhøjet risiko for knoglebrud. 
Protelos has also been compared with placebo in a main study involving 261 male patients at increased risk of breaking a bone.
Hvis man alene ser på kvinder på 74 år eller derover med specielt svage lårbensknogler, tyder resultaterne dog på, at Protelos mindsker risikoen for hoftebrud. 
However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Protelos.
I den første undersøgelse mindskede Protelos risikoen for nye brud på rygsøjlen med 41 % i løbet af tre år: 21 % af de 719 kvinder, der tog Protelos, fik nye brud på rygsøjlen, sammenholdt med 33 % af de 723, der fik placebo. 
In the first study, Protelos reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Protelos developed a new break in the spine, compared with 33% of the 723 who took placebo.
Da der er nogle data, som viser, at der er forhøjet risiko for hjerteanfald forbundet med Protelos, bør der tages højde for den enkelte patients risiko for hjerteproblemer, inden der træffes beslutning om at ordinere Protelos. 
As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient's individual heart risk.
I den første undersøgelse blev dette bedømt på, hvor stort et antal patienter, der i løbet af tre år fik et nyt brud på rygsøjlen, og i den anden undersøgelse på, hvor mange patienter, der fik et nyt knoglebrud på grund af osteoporose ethvert andet sted end på rygsøjlen. 
In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new bone break due to osteoporosis at any site other than the spine.
Der tages et brev Protelos en gang dagligt. 
Protelos is taken as one sachet once a day.
Det aktive stof i Protelos, strontiumranelat, indvirker på knoglernes struktur. 
The active substance in Protelos, strontium ranelate, acts on the bone structure.
Protelos anvendes til behandling af svær osteoporose (knogleskørhed) hos kvinder efter overgangsalderen og mænd, som har forhøjet risiko for brud og ikke kan behandles med andre lægemidler til behandling af osteoporose. 
Protelos is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
I begge undersøgelser blev Protelos sammenlignet med placebo (en virkningsløs behandling), og virkningen blev hovedsagelig bedømt på risikoen for et nyt knoglebrud med Protelos. 
In both studies, Protelos was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Protelos.
Hvordan blev Protelos undersøgt? 
How has Protelos been studied?
Hvad er Protelos? 
What is Protelos?
Den fuldstændige liste over indberettede bivirkninger ved Protelos fremgår af indlægssedlen. 
For the full list of all side effects reported with Protelos, see the package leaflet.
Hos kvinder efter overgangsalderen mindsker Protelos risikoen for knoglebrud i rygsøjlen og hoften. 
In postmenopausal women, Protelos reduces the risk of vertebral and hip fractures.
Hvilken fordel viser undersøgelserne, at der er ved Protelos? 
What benefit has Protelos shown during the studies?
Hvordan anvendes Protelos? 
How is Protelos used?
Undersøgelsen af mandlige patienter viste, at hos de patienter, der tog Protelos, blev knogletætheden i den nederste del af rygsøjlen forøget med 7 % efter et års behandling. 
In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Protelos, compared with an increase of 1.7% in patients taking placebo.
Hvad anvendes Protelos til? 
What is Protelos used for?
Hvordan virker Protelos? 
How does Protelos work?
Virkningsmekanismen er ikke fuldt ud klarlagt. 
The mechanism of action is not fully understood.
Disse produkter er ikke godkendt i større dele af EU, og derfor er de tilgængelige oplysninger begrænsede. 
These products are not widely authorised in the European Union and therefore availability of data is limited.
Ikke desto mindre er billedet af virkningsmekanismen til dato ufuldstændigt. 
Nevertheless, the picture of the mode of action remains incomplete until today.
Det fås som enkeltstofbehandling, men også i forskellige kombinationsprodukter. 
It is available as monocomponent but also available in several combination products.
Dermed kan de mere indgribende intramuskulære injektioner undgås, idet intravenøs indgift anses for at være et egnet alternativ. 
Thus, the more intrusive intramuscular injections could be avoided as intravenous administration is seen as a suitable alternative option.
Selvom metamizolholdige lægemidler er blevet trukket tilbage i adskillige europæiske lande og USA på grund af risikoen for agranulocytose, anvendes stoffet hyppigt i andre lande som f.eks. Spanien, Polen og Tyskland. 
Whilst metamizolecontaining medicinal products were withdrawn in several European countries and also in the USA due to the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.
I tilfælde af en enkelt administration af metamizol bør modermælk bortskaffes i 48 timer bagefter, før amning kan genoptages. 
In case of a single administration of metamizole, breastmilk should be discarded for a 48-hour period before breastfeeding can be resumed.
Enkeltdosen kan tages op til 4 gange dagligt med 6-8 timers mellemrum. 
This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Der var ingen tilgængelige oplysninger, der understøttede en ændring i doseringsanbefalingerne for stikpille-formuleringen på 100 mg og 200 mg samt kombinationsprodukterne. 
No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Visse oplysninger tyder på, at metamizol og dets hovedmetabolit, 4-methyl-amino-antipyrin (MAA), kan have en central og perifer virkningsmekanisme. 
Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Det aktive stof er kontraindiceret ved graviditet og amning i nogle medlemsstater, mens det i andre kun er kontraindiceret i tredje trimester af en graviditet; derudover er det i nogle medlemsstater kontraindiceret i første og tredje trimester af en graviditet og ved amning. 
The active substance is contraindicated in pregnancy and breastfeeding in some Member States, while in others it is contraindicated only in the third trimester of pregnancy and breastfeeding; furthermore, in some Member States it is contraindicated in the first and third trimester of pregnancy and breastfeeding.
I lyset af de kendte risici ved brug af metamizol giver forskellene i produktinformationen for metamizolholdige lægemidler mellem EU-medlemsstaterne grund til bekymring. 
In view of the known risks associated with the use of metamizole, the differences between the product information of metamizole-containing medicines across the EU Member States raise concern.
CHMP bemærkede desuden, at to nylige studier viste, at intravenøse enkeltdoser af metamizol til forebyggelse eller behandling af postoperative smerter var sikre hos flere end 400 spædbørn under 1 år (Fieler M et al. 20151, Sümpelmann R et al. 20172). 
The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).