natgillin/translations-raw huggingface dataset:
Tilfælde af en tilstand kaldet lactacidose, som er en ophobning af mælkesyre i kroppen, som kan forårsage dehydrering og koma, er i sjældne tilfælde set hos patienter, der tager NRTI’ er (se ” Vær ekstra forsigtig med at tage Ziagen ” i afsnit 2 for mere information).
61 Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see “ Take special care with Ziagen” in section 2 for more information).
Brug ikke Ziagen efter den udløbsdato, der står på pakningen.
Do not store above 30°C.
Udløbsdatoen er den sidste dag i den nævnte måned.
Discard oral solution two months after first opening.
Må ikke opbevares over 30 °C.
Do not use Ziagen after the expiry date which is stated on the package.
Ziagen oral opløsning indeholder 20 mg af det aktive indholdsstof abacavir (som sulfat) i hver milliliter oral opløsning.
Ziagen oral solution contains 20 mg of the active ingredient abacavir (as sulfate) in each ml of the solution.
Sorbitol 70% (E420), saccharinnatrium, natriumcitrat, vandfri citronsyre, methylparahydroxybenzoat (E218), propylparahydroxybenzoat (E216), propylenglycol (E1520), maltodextrin, mælkesyre, glyceryltriacetat, naturlig og syntetisk jordbær - og banansmagsstof, renset vand.
Sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, natural and artificial strawberry and banana flavour, purified water.
Ziagen oral opløsning er klar til gullig i farven og med jordbær - / banansmag.
Ziagen oral solution is clear to yellowish in colour with strawberry/ banana flavouring.
Den findes i en karton med en hvid polyethylenflaske med et børnesikret låg.
It is supplied in cartons containing a white polyethylene bottle, with a child resistant cap.
Flasken indeholder 240 ml (20 mg abacavir/ ml) oral opløsning.
The bottle contains 240 ml (20 mg abacavir/ ml) of solution.
Pakningen indeholder en 10 ml doseringssprøjte og en plastikadaptor (tilpasningsstykke) til flasken.
A 10 ml oral dosing syringe and a plastic adapter for the bottle is included in the pack.
63 Indehaveren af markedsføringstilladelsen og fremstiller
62 Marketing Authorisation Holder and Manufacturer
Hvis du vil have yderligere oplysninger om Ziagen, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
64 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0) 1 4955000
63 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
65
64
lg EMEA/ H/ C/ 691
ise EMEA/ H/ C/ 691
sa EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
ret Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
This document is a summary of the European Public Assessment Report (EPAR).
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte
It explains how the
ise undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
ra Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Hvis du ønsker
If you want more information on the basis
tor yderligere oplysninger om baggrunden for CHMP’ s anbefalinger, kan du læse de faglige drøftelser (også en del af denne af EPAR).
ge of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Hvad er ZIMULTI? au ZIMULTI er et lægemiddel, som indeholder det aktive stof rimonabant.
What is ZIMULTI? lon ZIMULTI is a medicine containing the active substance rimonabant.
Det leveres som hvide, dråbeformede tabletter. ere Hvad anvendes ZIMULTI til?
It is available as white, teardrop- shaped tablets.
30 kg/ m², eller • som er overvægtige (med et BMI større end eller lig med 27 kg/ m²), og som også har en eller læ
What is ZIMULTI used for? no
flere andre risikofaktorer som f. eks. type 2- diabetes eller dyslipidæmi (unormalt højt fedtindhold i blodet).
ZIMULTI is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
Lægemidlet udleveres kun efter recept. ke
The medicine can only be obtained with a prescription. ct
Hvordan anvendes ZIMULTI?
How is ZIMULTI used? du
følge en diæt med reduceret kalorieindhold og øge deres fysiske aktivitetsniveau.
The patients should also follow a reduced calorie diet and increase their level of physical activity.
Lægemidlet bør ikke anvendes til patienter med alvorlige lever - eller nyreproblemer. te
The medicine should not be used in patients who have severe problems with their liver or their kidneys. ro
Det aktive stof i ZIMULTI, rimonabant, er en cannabinoid- receptorantagonist.
The active substance in ZIMULTI, rimonabant, is a cannabinoid receptor antagonist.
Det virker ved at blokere en bestemt type receptorer, der kaldes cannabinoid- receptorer type 1 (CB1).
specific type of receptors, the cannabinoid type 1 (CB1) receptors.
nervesystemet og udgør en del af kroppens system til kontrol af fødeindtagelse.
These receptors are found in the nervous system, and they are part of the system the body uses to control food intake.
Receptorerne findes også i adipocytter (fedtvæv). mi
The receptors are also found in adipocytes (fat tissue). ina
Der er foretaget fire undersøgelser af ZIMULTI hos næsten 7 000 overvægtige og svært overvægtige ge
The effects of ZIMULTI were first tested in experimental models before being studied in humans.
En af undersøgelserne så især nærmere på patienter med unormalt højt fedtindhold i blodet, og en anden så nærmere på patienter med type 2- diabetes.
Four studies of ZIMULTI in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg.
Undersøgelserne sammenlignede virkningen af ZIMULTI med Læ
One study looked more dic
placebo (en uvirksom behandling) med hensyn til vægttab over et til to år.
The studies compared the effect of ZIMULTI with that of a placebo (a dummy treatment) on weight loss over one to two years.
En undersøgelse så også nærmere på, hvordan dette vægttab kunne vedligeholdes det andet år.
Me
Der er desuden foretaget fire undersøgelser af ZIMULTI, hvor det blev anvendt som hjælp til at stoppe rygning.
Four studies of ZIMULTI as a help to stop smoking were also carried out in over 7,000 patients,
Undersøgelserne, der omfattede over 7 000 patienter, sammenlignede lægemidlet med placebo og
d comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one
lg målte virkningen af behandlinger på 10 uger (et år i nogle af undersøgelserne) med hensyn til opnåelse af rygestop og tilbagefald det følgende år.
ise of the studies) on smoking cessation, and on relapses in the following year.
sa Hvilken fordel viser undersøgelserne, at der er ved ZIMULTI?
What benefit has ZIMULTI shown during the studies?
Efter et år havde alle patienter, der fik ZIMULTI, opnået et større vægttab end dem, der fik placebo: de
After one year, all patients who received ZIMULTI lost more weight than those who received placebo:
til tabte gennemsnitligt 4, 9 kg mere end patienterne i placebo- gruppen, undtagen i undersøgelsen af sukkersygepatienter, hvor forskellen i vægttabet var 3, 9 kg.
or they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Undersøgelserne med hensyn til opnåelse af rygestop gav ikke ensartede resultater,
The studies in smoking cessation did not show consistent results, and the effect of ZIMULTI in this area
ret og det var vanskeligt at vurdere virkningen af ZIMULTI på dette område.
uth was difficult to estimate.
ise Hvilken risiko er der forbundet med ZIMULTI?
What is the risk associated with ZIMULTI?
I løbet af undersøgelserne var de hyppigste bivirkninger ved ZIMULTI (som ses hos flere end 1 ud af 10
ra During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
ZIMULTI bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for rimonabant
ZIMULTI should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the
au eller andre af indholdsstofferne, eller af patienter, som ammer.
ge other ingredients, or in women who are breast feeding.
Patienter, der har symptomer på ere depression, bør tale med deres læge og eventuelt afbryde behandlingen.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
ZIMULTI bør anvendes med forsigtighed i kombination med visse lægemidler, f. eks. ketoconazol eller itraconazol (lægemiddel mod svamp), ritonavir (anvendes ved hiv- infektion), telithromycin eller clarithromycin (antibiotika). ng
Caution should be lon used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at ZIMULTI har vist sig effektivt til læ
The Committee for Medicinal products for Human Use (CHMP) concluded that ZIMULTI had shown its no
opnåelse af vægttab hos overvægtige eller svært overvægtige patienter med tilknyttede risikofaktorer.
effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Udvalget besluttede, at fordelene ved ZIMULTI er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med risikofaktorer såsom type 2- diabetes eller dyslipidæmi.
The Committee decided that ZIMULTI’ s benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ke
The Committee recommended that ZIMULTI be given marketing authorisation. ct
ZIMULTI. r ik
Which measures are being taken to ensure the safe use of ZIMULTI? du
Firmaet anvender specifikke te
The company that makes ZIMULTI will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
databaser til overvågning af bivirkninger, navnlig bivirkninger forbundet med nervesystemet. dle
The company will use specific databases to monitor the side effects, especially those linked to the nervous system. ro
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ZIMULTI til sanofi- aventis den 19. juni 2006. mi
The European Commission granted a marketing authorisation valid throughout the European Union for lp
Den fuldstændige EPAR om ZIMULTI findes her. ge
The full EPAR for ZIMULTI can be found here. ina
Læ
This summary was last updated in 10-2007. dic Me
a lg EU- nummer EU/ 1/ 06/ 345/ 001 Særnavn ZIMULTI Styrke 20 mg Lægemiddelform Filmovertrukken tablet Indgivelsesvej Oral anvendelse Emballage Blister (PVC/ aluminium) ti ls Paknings- størrelse 14 tabletter EU/ 1/ 06/ 345/ 002
o administration EU/ 1/ 06/ 345/ 001
e t
t
28 tabletter
h
er EU/ 1/ 06/ 345/ 003 EU/ 1/ 06/ 345/ 004 EU/ 1/ 06/ 345/ 005
EU/ 1/ 06/ 345/ 002 EU/ 1/ 06/ 345/ 003
ZIMULTI ZIMULTI ZIMULTI
ZIMULTI ZIMULTI
Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet Film-coated tablet
Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use
Blister (PVC/ aluminium) Blister (PVC/ aluminium) Blister (PVC/ aluminium)
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
56 tabletter 70x1 tabletter 84 tabletter
28 tablets 56 tablets
is EU/ 1/ 06/ 345/ 006
u EU/ 1/ 06/ 345/ 004
98 tabletter
70x1 tablets
or EU/ 1/ 06/ 345/ 007 EU/ 1/ 06/ 345/ 008
a EU/ 1/ 06/ 345/ 005 EU/ 1/ 06/ 345/ 006
Dåse (HDPE) Dåse (HDPE)
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
28 tabletter 98 tabletter
84 tablets 98 tablets
t EU/ 1/ 06/ 345/ 009
r EU/ 1/ 06/ 345/ 007
500 tabletter
98 tablets 500 tablets
u EU/ 1/ 06/ 345/ 010
g EU/ 1/ 06/ 345/ 010
a EU/ 1/ 06/ 345/ 011
n EU/ 1/ 06/ 345/ 011
Læ ge mi dle te r ik ke læ
d ise or uth ra ge ANNEX I on
1 BILAG I ng ere PRODUKTRESUME au tor ise ret til sa lg 1.
SUMMARY OF PRODUCT CHARACTERISTICS ol tn uc d ro lp ina dic Me
sa En tablet indeholder 20 mg rimonabant.
Each tablet contains 20 mg rimonabant.
Tabletterne indeholder cirka 115 mg laktose.
115 mg lactose.
ise Filmovertrukken tablet.
d Film-coated tablet
Bikonvekse, tåreformede, hvide tabletter mærket med ” 20 ” på den ene side.
ise Biconvex, teardrop-shaped, white tablets debossed with “ 20” on one side.
tor 4.
or uth 4.
5. 1).
ra As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/ m2), or overweight ge patients (BMI > 27 kg/ m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1). on
4. 2 Dosering og indgivelsesmåde ng
4.2 Posology and method of administration ol tn
Til voksne er den anbefalede dosis en 20 mg tablet dagligt som tages om morgenen før morgenmaden. læ
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. uc
Behandlingen bør introduceres med en lettere reduceret kaloriediæt.
The treatment should be introduced with a mildly reduced calorie diet. d ro
Sikkerhed og effekt af rimonabant er ikke undersøgt ud over 2 år. ke
The safety and efficacy of rimonabant have not been evaluated beyond 2 years. lp
Specielle patientgrupper r ik
• Special Populations ina
ZIMULTI bør anvendes med forsigtighed te
ZIMULTI should be used with caution dic
hos patienter ældre end 75 år (se pkt.
in patients over 75 years of age (see section 4.4).
4. 4).
Me
Patienter med nedsat leverfunktion: dle
Patients with hepatic insufficiency:
4. 4 og 5. 2). mi
ZIMULTI should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
5. 2). ge
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
4. 4 og 5. 2).
ZIMULTI should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
Læ
Paediatrics:
ZIMULTI er ikke anbefalet til brug hos børn under 18 år p. g. a. mangel på data vedrørende effekt og sikkerhed.
ZIMULTI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
lg 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
sa • Depressive sygdomme Depressive sygdomme eller humørændringer med depressive symptomer er rapporteret hos op til 10
• Depressive disorders Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8).
4. 3 og 4. 8).
In patients with current suicidal ideations and/ or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
Fedme er en tilstand som kan associeres med depressive sygdomme.
(See section 4.3 and 4.8). Obesity is a condition that can be associated with depressive disorders.
Depressive sygdomme kan
Depressive disorders can be associated with an increased risk of suicidal
ise associeres med en øget risiko for at gøre skade på sig selv, selvmordstanker og selvmord.
d thoughts, self harm and suicide.
For at kunne vurdere de potentielle risici ved behandling med rimonabant, bør lægen nøje undersøge,
ise The prescriber should carefully investigate if the patient has had a depressive disorder in the past in
tor om patienten tidligere har haft en depressiv sygdom.
or order to evaluate the potential risks with rimonabant treatment.
Depressive tilstande kan forekomme hos patienter, som ikke har nogen åbenlyse risikofaktorer, bortset
uth Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
au fra fedme.
ra so within 1 month of starting treatment, approximately 80% appear to do so within 3 months.
Erfaring efter markedsføring viser at mere en halvdelen af de patienter, som får disse reaktioner, får dem inden for en måned efter start af behandling, mere end 80% inden for de 3 første måneder. ere Patienter skal efter start af behandlingen, aktivt monitoreres for tegn og symptomer på psykiske sygdomme, især depression.
Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly ge depression following the start of treatment.
Patienten skal monitoreres og behandles på passende vis. ng
The patient should be monitored and treated appropriately. on
Patienter, især dem med depressive sygdomme/ humør ændringer i anamnesen, (og pårørende eller andre relevante personer) bør gøres opmærksom på, at det er nødvendigt at monitorere forekomsten af læ
Patients, especially those with a history of depressive disorders/ mood alterations, (and relatives or ol
sådanne symptomer og at søge læge øjeblikkeligt, hvis de skulle forekomme.
other relevant persons) should be alerted about the need to monitor for the emergence of such tn
Hvis psykisk ke
symptoms and to seek medical advice immediately if these occur. uc
sygdom diagnosticeres under behandling med rimonabant, skal behandlingen ophøre. r ik
• Other psychiatric conditions Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness. d
• Kramper Rimonabant er ikke undersøgt hos patienter i behandling for epilepsi.
If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped. ro
Dog bør te
• Seizures lp
5. 3.
Rimonabant has not been studied in patients being treated for epilepsy.
• Nedsat leverfunktion dle
In clinical trials no difference ina
Rimonabant metaboliseres i leveren, og derfor anbefales forsigtighed ved behandling af patienter med moderat nedsat leverfunktion.
in the incidence of seizures was seen in patients receiving rimonabant or placebo.
Farmakokinetik og sikkerhed af rimonabant er ikke undersøgt hos patienter med svært nedsat leverfunktion; anvendelse hos disse patienter anbefales ikke. mi
Rimonabant, however, should be used with caution in these patients, see also section 5.3. dic
• Nedsat nyrefunktion Der er begrænset data hos patienter med moderat nedsat nyrefunktion og ingen data vedrørende ge
• Hepatic impairment Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic Me
patienter med svært nedsat nyrefunktion.
• Renal impairment There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Læ
Rimonabant should not be used in patients with severe renal impairment (see section 4.2 and 5.2).
• Ældre Effekt og sikkerhed af rimonabant hos patienter over 75 år er ikke tilstrækkeligt fastsat.
• Elderly The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established.
3 • Race Den kliniske effekt (vægttab) af rimonabant hos negroide er lavere end hos kaukasiere.
3 • Race The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
5. 2).
This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure (see section 5.2).
lg • Diabetes patienter
• Diabetic patients
sa På grund af rimonabants effekt på blodsukkerniveauet, kan hypoglykæmi forekomme, når rimonabant gives til diabetes patienter (se afsnit 4. 8).
Due to the effect of rimonabant on the blood glucose level, when rimonabant is administered in diabetic patients, hypoglyceamia can occur (see section 4.8).
4. 5).
• Drug Interaction Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
ise • Lactose Da ZIMULTI indeholder laktose, bør patienter med sjældne, arvelige problemer med
d ise • Lactose Since ZIMULTI tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this
tor galaktoseintolerans, Lapp laktasemangel eller glukose- galaktose malabsorption, ikke tage denne medicin.
or medicine.
au Patienter bør instrueres i ikke at forøge dosis af ZIMULTI.
uth Patients should be instructed not to increase their dose of ZIMULTI.
Patienter som havde haft kardivaskulært event (myokardieinfarkt, hjerteanfald etc.) inden for mindre ere end 6 måneder, blev ekskluderet i forsøgene med rimonabant.
ra Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago were excluded in the studies for rimonabant. ge 4.5 Interaction with other medicinal products and other forms of interaction on ol
Samtidig læ
Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of tn
administration af CYP3A4 fremmere forventes at føre til reduceret optagelse af rimonabant.
Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant. uc
Potentiale for andre lægemidler for påvirkning af rimonabant:
Potential for other medicinal products to affect rimonabant: d
Samtidig administration af ketoconazol (en potent CYP3A4 hæmmer) forøgede AUC for rimonabant ke
Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC ro
med 104% (95% confidensinterval:
by 104% (95% prediction interval:
Forsigtighed anbefales under samtidig anvendelse af r ik
Caution is advised during concomitant use of ZIMULTI and potent lp
ZIMULTI og potente CYP3A4 hæmmere (f. eks. ketoconazol, itraconazol, ritonavir, telithromycin, clarithromycin, nefazodon).
CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, ina
Selvom samtidig administration med CYP3A4 fremmere (f. eks. rifampicin, phenytoin, phenobarbital, te
Although concomitant administration of CYP3A4 inducers (e. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John’ s wort) has not been studied, it is expected that concomitant administration of dic
carbamazepine, Hyperikum Perforatum) ikke er undersøgt, forventes det, at samtidig administration af potente CYP3A4 fremmere kan reducere plasmakoncentrationen af rimonabant og kan resultatere i tab af effekt. dle
Me
Samtidig administration af orlistat, ethanol eller lorazepam havde ingen signifikant effekt på plasmaniveauet af rimonabant. mi
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.
hæmmende effekt på CYP2C8.
However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
Læ
Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Der kan ikke konkluderes på baggrund af data fra dyr, men de tyder på skadelige virkninger på embryonal/ foetal udvikling (se pkt.
Animal data are inconclusive but suggest possible deleterious effects on embryonal/ foetal development (see section 5.3).
sa Rimonabant har været påvist i mælken fra diegivende rotter og rimonabant kan hæmme sutterefleksen.
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
ZIMULTI er kontraindiceret under amning
ZIMULTI is contraindicated during breast-feeding (see section 4.3).
4. 3).
4.7 Effects on ability to drive and use machines
ret 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
No studies on the effects on the ability to drive and use machines have been performed.