natgillin/translations-raw huggingface dataset:
Der findes også startpakninger med 42 tabletter til de første uger af behandlingen, hvor dosis langsomt øges.
Starter packs containing 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Før du tager Lamictal, skal du fortælle lægen: - om du har problemer med nyrerne - om du nogensinde har fået udslæt, mens du har taget lamotrigin eller andre lægemidler til behandling af epilepsi - om du allerede tager medicin, der indeholder lamotrigin.
• if you have ever developed a rash when you've taken lamotrigine or other medicines for epilepsy
2 mg dispergible tabletter / tyggetabletter:
2 mg dispersible/chewable tablets:
Lamictal 200 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner.
Lamictal 200 mg dispersible/chewable tablets are square with rounded corners.
100 mg dispergible tabletter / tyggetabletter:
100 mg dispersible/chewable tablets:
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CL7" på den ene side og "100" på den anden side.
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other.
200 mg dispergible tabletter / tyggetabletter:
200 mg dispersible/chewable tablets:
GlaxoSmithKline UK
GlaxoSmithKline ehf.
Hver pakning med blistere indeholder 10, 30, 50, 56, 60, 90, 100 eller 200 tabletter.
Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Lamictal 25 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner.
Lamictal 25 mg dispersible/chewable tablets are square with rounded corners.
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE7" på den ene side og "200" på den anden side.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE7” on one side and “200” on the other.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 50 mg lamotrigine
25 mg dispergible tabletter / tyggetabletter:
25 mg dispersible/chewable tablets:
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE1" på den ene side og "50" på den anden side.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE1” on one side and “50” on the other.
Lamictal 100 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner.
Lamictal 100 mg dispersible/chewable tablets are square with rounded corners.
5 mg dispergible tabletter / tyggetabletter:
5 mg dispersible/chewable tablets:
Hver Lamictal 50 mg dispergibel tablet / tyggetabletindeholder 50 mg lamotrigin.
Each Lamictal 50 mg dispersible/chewable tablet contains 50 mg lamotrigine.
Lamictal 50 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner.
Lamictal 50 mg dispersible/chewable tablets are square with rounded corners.
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EC7" på den ene side og "25" på den anden side.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEC7” on one side and “25” on the other.
Lamictal 100 mg disperzibilne/žvečljive tablete
Lamictal 100 mg disperzibilne/žvečljive tablete 100 mg Dispersible/Chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets.
Lamictal 5 mg disperzibilne/žvečljive tablete
Lamictal 5 mg disperzibilne/žvečljive tablete 5 mg Dispersible/Chewable Tablet
50 mg dispergible tabletter / tyggetabletter:
50 mg dispersible/chewable tablets:
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets.
Lever og galdeveje Meget sjælden:
Immune system disorders Very rare:
Lamictal 50 mg disperzibilne/žvečljive tablete
Lamictal 50 mg disperzibilne/žvečljive tablete 50 mg Dispersible/Chewable Tablet
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CX7" på den ene side og "50" på den anden side.
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other.
Lamictal og tilknyttede navne (se bilag I) 100 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE5" på den ene side og "100" på den anden side.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE5” on one side and “100” on the other.
Lamictal og tilknyttede navne (se bilag I) 200 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 100 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 100 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 2 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets.
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CL5" på den ene side og "25" på den anden side.
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other.
200 mg Dispergible / tyggetabletter
200 mg Dispersible/Chewable Tablets
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 200 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 200 mg lamotrigine
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS EC5" på den ene side og "200" på den anden side.
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSEC5” on one side and “200” on the other.
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter [Se bilag 1 - udfyldes nationalt] Lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 25 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 25 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets.
100 mg Dispergible eller tyggetabletter
100 mg Dispersible or chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 5 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 5 mg lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 2 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 2 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 50 mg lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 50 mg lamotrigine
200 mg Dispergible eller tyggetabletter
200 mg Dispersible or chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 2 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal 5mglösliche Tabletten
Lamictal 5mg - lösliche Tabletten
2 mg Dispergible / tyggetabletter
2 mg Dispersible/Chewable Tablets
100 mg Dispergible / tyggetabletter
100 mg Dispersible/Chewable Tablet
5 mg Dispergible eller tyggetabletter
5 mg Dispersible or chewable Tablet
Lamictal dispergible tabletter / tyggetabletter indeholder:
What Lamictal tablets contain
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Vedligeholdelsesdosen af lamotrigin skal i de fleste tilfælde reduceres med op til 50 % (se pkt.
Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
Hvis du vil have yderligere oplysninger om Lamictal, skal du henvende dig til den lokale repræsentant:
Take special care with Lamictal Your doctor needs to know before you take Lamictal:
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter [se bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
25 mg Dispergible eller tyggetabletter
25 mg Dispersible or chewable Tablet
Oversigt over indlægssedlen:
To make a liquid medicine:
50 mg Dispergible / tyggetabletter
50 mg Dispersible/Chewable Tablets
Medbring denne indlægsseddel og/eller pakningen, hvis du har mulighed for det.
If possible, show them the Lamictal packet.
50 mg Dispergible eller tyggetabletter
50 mg Dispersible or chewable Tablet
Derfor kan metaboliseringen af folat blive påvirket ved længerevarende behandling (se pkt.
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
2 mg Opløselige tabletter
2 mg Soluble Tablet
Tilføjelse af valproat (hæmmer af lamotrigin-glukuronidering - se pkt.
Addition of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Seponering af valproat (hæmmer af lamotrigin-glukuronidering - se pkt.
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
5 mg Dispergible / tyggetabletter
5 mg Dispersible/Chewable Tablet
5 mg Opløselige tabletter
5 mg Soluble Tablet
Andre oplysninger om Tredaptive:
Other information about Tredaptive:
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tredaptive.
The Committee recommended that Tredaptive be given marketing authorisation.
Startdosis for Tredaptive er én tablet én gang dagligt i fire uger, hvorefter dosis øges til to tabletter én gang dagligt.
The starting dose of Tredaptive is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tredaptive til Merck Sharp & Dohme Ltd.
The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Den fuldstændige EPAR for Tredaptive findes her.
The full EPAR for Tredaptive can be found here.
Virkningerne af Tredaptive blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Tredaptive were first tested in experimental models before being studied in humans.
Tredaptive anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning hos denne aldersgruppe.
Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TREDAPTIVE EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
Tredaptive anvendes alene hos patienter, der ikke tåler statiner.
Tredaptive is used on its own only in patients who cannot take statins.
Den mest almindelige bivirkning ved Tredaptive (som optræder hos flere end 1 ud af 10 patienter) er flushing.
The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
De omfattede i alt 2 349 patienter, som tog enten Tredaptive eller nikotinsyre.
They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Tredaptive anvendes normalt sammen med et statin (standard kolesterolsænkende lægemiddel), når virkningen af et statin alene er utilstrækkelig.
Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Den anden undersøgelse viste, at indholdet af LDL-kolesterol blev yderligere sænket, når Tredaptive blev givet sammen med simvastatin (48 % reduktion) sammenlignet med Tredaptive alene (17 % reduktion) eller simvastatin alene (37 % reduktion).
The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Den anden undersøgelse sammenlignede kombinationen af Tredaptive og simvastatin (et statin) med Tredaptive alene eller simvastatin alene hos 1 398 patienter.
The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
De to aktive stoffer i Tredaptive, nikotinsyre og laropiprant, har forskellige virkemåder.
The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Den fuldstændige liste over alle de indberettede bivirkninger ved Tredaptive fremgår af indlægssedlen.
For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Hvilken risiko er der forbundet med Tredaptive?
What is the risk associated with Tredaptive?
Tredaptive er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3-vitamin) og laropiprant.
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
I Tredaptive-tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
I den første undersøgelse blev indholdet af LDL-kolesterol reduceret med 19 % hos patienter, der fik Tredaptive, sammenlignet med 1 % hos dem, der fik placebo.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Tredaptive blev undersøgt i fire hovedundersøgelser af patienter med hyperkolesterolæmi eller blandet dyslipidæmi.
Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tredaptive er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Tredaptive bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nikotinsyre, laropiprant eller andre af indholdsstofferne.
Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Tredaptive var effektivt til at sænke blodets indhold af LDL-kolesterol.
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Tredaptive anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Hvorfor blev Tredaptive godkendt?
Why has Tredaptive been approved?
I den fjerde undersøgelse optrådte flushing færre dage hos patienter, som fik Tredaptive, end hos dem, der fik nikotinsyre alene.
In the fourth study, flushing was seen on fewer days in patients taking Tredaptive than in those taking nicotinic acid alone.
I den første og den tredje undersøgelse oplevede færre patienter, der fik Tredaptive, moderat, svær eller ekstrem flushing, end det var tilfældet hos patienter, der fik nikotinsyre alene.
In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Hvad er Tredaptive?
What is Tredaptive?
To undersøgelser så nærmere på Tredaptives virkning med hensyn til sænkning af blodets fedtindhold.
Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Hvilken fordel viser undersøgelserne, at der er ved Tredaptive?
What benefit has Tredaptive shown during the studies?
Hvordan blev Tredaptive undersøgt?
How has Tredaptive been studied?
Hvad anvendes Tredaptive til?
What is Tredaptive used for?
Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Tredaptive med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL-kolesterol.
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Hvordan anvendes Tredaptive?
How is Tredaptive used?
Hvordan virker Tredaptive?
How does Tredaptive work?
De vil vurdere, hvor meget du har brug for.
They will decide how much you need.
Atosiban må ikke anvendes under følgende omstændigheder:
Atosiban must not be used in the following conditions:
De fleste af de behandlinger i CAP-001, der slog fejl, var forårsaget af dårlig tolerance.
Most of the treatment failures in CAP-001 were caused by poor tolerability.
Nedenstående oplysninger er til læger og sundhedspersonale: (Se også punkt 3)
The following information is intended for healthcare professionals only: (See also section 3)
Ikke relevant
Not relevant.
Op til 270 mg intravenøs infusion
Up to 270 mg intravenous infusion
Dato for første markedsføringstilladelse: 31 juli 2013 Dato for seneste fornyelse: 28 maj 2018
Date of latest renewal: 28 May 2018
Det vides ikke, om M1 ophobes i væv.
It is not known whether M1 accumulates in tissues.
De bivirkninger, som er set hos moderen, er generelt milde.
The side effects seen in the mother are generally mild.
Der var ingen forskel mellem atosiban- og beta-mimetika-gruppen med hensyn til denne parameter.
There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Plasmaproteinbindingen for atosiban er hos gravide kvinder 46-48 %.
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Dette giver vedvarende uafhængig kontrol over infusionshastigheden.
This permits the continued independent control of the rate of infusion.
Du får Atosiban SUN på et hospital af en læge, sygeplejerske eller jordemoder.
Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
0,9 ml intravenøs bolus
0.9 ml intravenous bolus
Såfremt der anvendes en infusionspose med et andet volumen skal en forholdsmæssig beregning udføres med henblik på klargøring af denne.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Det frarådes at foretage mere end tre genbehandlinger under en graviditet.
It is recommended that no more than three retreatments should be used during a pregnancy.
Der blev ikke observeret nogen systemiske, toksiske virkninger i løbet af de to-uger lange intravenøse toksicitetsafprøvninger (hos rotter og hunde) ved doser cirka 10 gange højere end den terapeutiske dosis for mennesker, eller i løbet af tre måneders toksicitetsafprøvninger hos rotter og hunde (op til 20 mg/kg/dag s.c.).
No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the three-months toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
4.6 Fertilitet, graviditet og amning Graviditet
4.6 Fertility, pregnancy and lactation
Hovedmetabolitten M1 er ca. 10 gange mindre potent end atosiban med hensyn til at hæmme oxytocin-inducerede uteruskontraktioner in vitro.
The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocin-induced uterine contractions in vitro.
Hvis det er nødvendigt at indgive andre medikamenter intravenøst på samme tidspunkt, kan den intravenøse kanyle deles eller et andet intravenøs indgivelsessted benyttes.
If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Sekundære endpoints: Sekundære effektparametre omfattede den andel af kvinderne, der forblev uforløste inden for 48 timer fra iværksættelsen af behandlingen.
Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Det er påvist, at små mængder atosiban passerer fra plasma over i brystmælken hos ammende kvinder.
Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
- hvis du er mellem 24 og 27 uger henne i graviditeten
- If you are between 24 and 27 weeks pregnant.
Behandling med atosiban skal initieres og vedligeholdes af en læge, som har erfaring i at behandle for tidlig fødsel.
Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
I alt oplevede 48 % af de patienter, der blev behandlet med atosiban, bivirkninger under de kliniske forsøg.
In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Der er kun begrænset klinisk erfaring med brug af atosiban ved flerfoldssvangerskaber eller ved en gestationsalder fra 24 til 27 uger, pga. det lille antal behandlede patienter.
There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.