natgillin/translations-raw huggingface dataset:
7 For at forebygge en eller flere nye vertebralfrakturer skal 48 kvinder fra den totale population, gennemsnitligt behandles i 18 måneder.
To prevent one or more new vertebral fractures, 48 women had to be treated for a median of 18 months for the total population.
Der var ingen signifikant forskel mellem forekomsten af non- vertebrale kliniske frakturer i de to behandlingsgrupper:
There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture:
5, 52% i Preotactgruppen og 5, 86% i placebogruppen.
5.86% for placebo.
Den mest relevante reduktion i frakturer blev konstateret blandt kvinder med høj risiko for frakturer, som for eksempel kvinder med tidligere frakturer eller kvinder med en lumbal columna T- score < ÷3.
The most relevant fracture reduction was observed among patients at high risk of fractures such as patients with previous fractures and in patients with a lumbar spine T-score of < - 3.
Relativt få patienter inkluderet i fase III- studiet var < 5 år postmenopausalt og mellem 45 og 54 år (2 – 3%).
Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
Effekt på knoglemineraltæthed (BMD) Efter 18 måneders behandling med Preotact sås en stigning på 6, 5% i BMD i lumbal culumna sammenlignet med ÷0, 3% for placebo (p < 0, 001).
Effect on bone mineral density (BMD) In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p < 0.001).
Endvidere sås signifikante stigninger i hofte- BMD efter 18 måneders behandling på henholdsvis 1, 0; 1, 8 og 1, 0% (total, lårbenshals, trochanter) mod ÷1, 1; ÷0, 7 og ÷0, 6% for placebo (p < 0, 001).
Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1, -0. 7 and -0.6% for placebo (p < 0.001).
Fortsat behandling i op til 24 måneder i en åben- label forlængelse af studiet resulterede i en fortsat stigning i BMD.
7 Continued treatment for up to 24 months in an open-label extension of this study resulted in a continued increase in BMD.
Stigningen i BMD for lumbal columna og lårbenshalsen var henholdsvis 6, 8% og 2, 2% hos patienter behandlet med Preotact.
The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact.
Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 38% i forhold til baseline efter 18 måneder.
Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Tilsvarende sås en 4, 7% stigning i volumetrisk trabekulær BMD for total - hofte.
Similarly, volumetric trabecular BMD at the total hip increased by 4.7%.
Preotact reducerede den volumentriske kortikale knogle- BMD (målt i distal radius og midt på tibia), mens den periostale omkreds eller index for den kortikale knoglestyrke blev bibeholdt.
Treatment with Preotact reduced volumetric cortical bone BMD (measured at the distal radius and mid-shaft tibia), while periosteal circumference or indices of cortical bone strength were maintained.
I et 24- måneders studie med kombinationsterapi med alendronat (PaTH) blev Preotacts effekt på knoglestrukturen også evalueret ved QCT.
In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 26; 13 og 11% (Preotact, Preotact- alendronat og alendronat) efter 12 måneder.
Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months.
På samme måde blev volumetrisk trabekulær BMD af total- hofte forøget med 9; 6 og 2% i de 3 grupper.
Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Behandling af osteoporose med kombinations - og sekvensterapi PaTH- studiet var et NIH sponsoreret, randomiseret, placebokontrolleret, 2- årigt, multicenter, dobbeltblindet studie med Preotact og alendronat som monoterapi eller kombinationsterapi til behandling af postmenopausal osteoporose.
Treatment of osteoporosis with combination and sequential therapy The PaTH study was a NIH sponsored randomised, placebo-controlled, 2 year, multicenter, double- blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
Inklusionkriterierne var kvinder mellem 55 og 85 år med BMD T- score under ÷2, 5 eller under ÷2 og mindst en yderligere risikofaktor for fraktur.
Inclusion criterias were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Alle kvinder fik calcium - (400 – 500 mg) og D- vitamintilskud (400 IE).
A ll women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
De blev fulgt i 12 måneder.
A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
I studiets 2. år blev kvinderne fra den oprindelige Preotact - gruppe randomiseret til enten alendronat - eller placebobehandling og kvinderne fra de 2 andre grupper fik alendronat.
In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
Ved baseline havde 165 kvinder (69%) en T- score under ÷2, 5 og 112 kvinder (47%) havde rapporteret minimum 1 fraktur efter menopause.
At baseline a total of 165 women (69%) had a T-score below –2.5, and 112 (47%) reported at least one fracture after menopause.
Efter 1 års behandling sås følgende resultater:
One year of therapy, showed the following results:
Stigningerne i BMD fra baseline for lumbal columna var ens i Preotact - og kombinationsbehandlingsgruppen (6, 3 og 6, 1%), men var lidt mindre i alendronat- gruppen (4, 6%).
The increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Stigningerne i BMD i total- hofte var henholdsvis 0, 3; 1, 9 og 3, 0% for de 3 behandlingsgrupper.
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
8 Ved afslutning på 2. år (12 måneder efter afbrydelse af Preotact) sås ved dual energy X- ray absorptiometri (DXA) en gennemsnitlig stigning på 12% i BMD i columna hos patienter, behandlet med alendronat i år 2.
At the end of year 2 (12 months after Preotact was discontinued), there was a 12.1% mean increase in dual energy X-ray absorptiometry (DXA) spine BMD for patients who received alendronate for the second year.
De patienter, der fik placebo i år 2, havde en gennemsnitlig stigning på 4% sammenlignet med baseline, men der var sket et lille fald i forhold til status efter 12 måneders Preotactbehandling.
For the patients who received placebo during the second year, the mean percent increase was 4.1% compared to baseline, but had decreased slightly compared to the end of 12 months of Preotact treatment.
Med hensyn til den gennemsnitlige ændring i knoglemineraltæthed for total- hofte sås en 4, 5% stigning i forhold til baseline efter 1 års alendronatbehandling og et 0, 1% fald efter 1 års placebobehandling.
For the mean change in hip BMD, there was a 4.5% increase from baseline with one year of alendronate compared to a 0.1% decrease after one year of placebo.
Kombinationsbehandling med Preotact og hormonsubstitutionsterapi (HRT) er afprøvet hos 180 postmenopausale kvinder og viste en signifikant stigning i BMD for lumbal columna efter 12 måneders behandling i forhold til HRT alene (7, 1% i forhold til 1, 1%, p < 0, 001).
1.1%, p < 0.001).
Kombinationen viste sig effektiv uafhængig af alder, knogle- turnover og baseline- BMD.
The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
5. 2 Farmakokinetiske egenskaber Absorption Subkutan administration af 100 mikrogram parathyreoideahormon i abdomen giver en hurtig stigning i plasmakoncentrationen af parathyreoideahormon og maksimal koncentration opnås 1 til 2 timer efter administration.
Absorption Subcutaneous administration of 100 micrograms of parathyroid hormone into the abdomen produces a rapid increase in plasma parathyroid hormone levels and achieves a peak at 1 to 2 hours after dosing.
Den gennemsnitlige halveringstid er omkring 1, 5 time.
8 The average half-life is of about 1.5 hours.
Den absolutte biotilgængelighed efter subkutan adminstration af 100 mikrogram parathyreoideahormon i abdomen er 55%.
The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Fordeling Fordelingsvolumenet ved steady state efter intravenøs administration er cirka 5, 41.
Distribution The volume of distribution at steady-state following intravenous administration is approximately 5.4 l.
Den inter - individuelle variation i fordelingsvolumenet for parathyreoideahormon er omkring 40%.
Intersubject variability in the volume of distribution of parathyroid hormone is about 40%.
Biotransformation Parathyreoideahormonet fjernes effektivt fra blodbanen ved en receptormedieret proces i leveren og nedbrydes her til mindre peptidfragmenter.
Biotransformation Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Fragmenter af den aminoterminale ende nedbrydes yderligere i levercellen, mens fragmenterne fra carboxy- enden frigives til blodbanen og fjernes af nyrerne.
The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Ved normale fysiologiske forhold udgøres kun 5 – 30% af de cirkulerende former af det intakte parathyreoideahormon (1- 84), mens 70 – 95% er til stede som carboxyterminale fragmenter.
Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
Efter en subkutan dosis parathyreoideahormon vil 60 – 90% af de cirkulerende former af molekylet være C- terminal- fragmenter.
Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Efter en intravenøs dosis vil den systemiske clearance af parathyroideahormenet (45, 3 l/ time) være tæt på det normale leverplasmaflow og stemmer overens med en omfattende metabolisering af lægemidlet i leveren.
Systemic clearance of parathyroid hormone (45.3 l/hour) following an intravenous dose is close to normal liver plasma flow and is consistent with extensive hepatic metabolism of the active substance.
Den inter- individuelle variation i den systemiske clearance ligger omkring 15%.
Intersubject variability in systemic clearance is about 15%.
Elimination Parathyreoideahormonet metaboliseres i leveren og i mindre grad i nyrerne.
Elimination Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Nedsat leverfunktion I et studie gennemført på 6 kvinder og 6 mænd med moderat nedsat leverfunktion sås en moderat stigning på cirka 20% af den gennemsnitlige systemiske eksponering, korrigeret for baseline (AUC) og sammenlignet med en matchende gruppe på 12 personer med normal leverfunktion.
Hepatic impairment There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Nedsat nyrefunktion Den overordnede systemiske eksponering og Cmax var let forhøjede (henholdsvis 22% og 56%) i en gruppe bestående af 8 kvinder og 8 mænd med let til moderat nedsat nyrefunktion (kreatininclearance 30 – 80 ml/ min) sammenlignet med en tilsvarende gruppe på 16 personer med normal nyrefunktion.
Renal impairment The overall exposure and Cmax of parathyroid hormone were slightly increased (22% and 56%, respectively) in a group of 8 male and 8 female subjects with mild-to-moderate renal impairment (creatinine clearances of 30 to 80 ml/min) compared with a matched group of 16 subjects with normal renal function.
9 Farmakokinetikken for parathyreoideahormonet er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min).
The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Ældre Der er ikke registreret forskelle i farmakokinetikken i forhold til alder (47 – 88 år).
Elderly No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Rotter, der blev behandlet næsten gennem hele levetiden med daglige injektioner, havde en dosisafhængig overdreven knogledannelse og en øget forekomst af knogletumorer inklusive osteosarkomer, hvilket mest sandsynligt skyldes en epigenetisk mekanisme.
9 Rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
Pulver Mannitol Citronsyremonohydrat Natriumchlorid Fortyndet saltsyre (til pH- justering) Natriumhydroxid 1N (til pH- justering)
Powder Mannitol Citric acid monohydrate Sodium chloride Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide 1N (for pH adjustment)
Solvens Meta- cresol Vand til injektionsvæsker
Solvent Metacresol Water for injections
Kemisk og fysisk in- use stabilitet er dokumenteret ved 28 dages opbevaring ved 2 – 8 °C.
Mixed solution: chemical and physical in-use stability has been demonstrated for 28 days at 2-8°C.
I den 28 dages periode kan den færdigblandede opløsning opbevares i op til 7 dage ved temperaturer under 25 °C.
During the 28-day period the mixed solution can be stored for up to 7 days at temperatures below 25°C.
Opbevar cylinderampullen i den ydre pakning for at beskytte den mod lyset.
Keep the cartridge in the outer carton in order to protect from light.
Færdigblandet opløsning:
Mixed solution:
Opbevares i køleskab (2 – 8 °C).
Store in a refrigerator (2-8°C).
6. 3).
Once the cartridge is mixed it can be stored outside the refrigerator at temperatures below 25°C for up to 7 days during the 28 day use period.(see section 6.3).
Pakningsmaterialet består af en tokammercylinderampul, en midterprop, en indfalset prop (med en gummiforsegling), som forsegler det første kammer med det frysetørrede pulver og en bundprop, der forsegler det andet kammer, der indeholder væsken til at opløse pulveret med.
The container closure system is comprised of a dual-chamber cartridge, a center stopper, a crimp cap (containing a rubber seal) sealing the first chamber containing lyophilised powder and an end stopper sealing the second chamber containing the solvent for mixing.
Cylinderampul:
Cartridge:
Cylinderampullen er fremstillet af glas Type I.
The glass of the dual-chamber cartridge is made of glass Type I.
Prop (midte og bund):
Stopper (center and end):
Proppen er fremstillet af brombutylgummi, grå.
The stopper is made of bromobutyl rubber, grey.
Indfalset prop (med gummiforsegling).
Crimp cap (containing a rubber seal):
Gummiforseglingen er lavet af brombutylgummi.
The crimp cap is made of aluminium and the rubber seal is made of bromobutyl rubber.
Hver cylinderampul indeholder 1, 61 mg parathyreoideahormon og 1, 13 ml solvens (14 doser).
10 Each dual-chamber cartridge contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses).
Preotact fås i pakninger med 2 eller 6 cylinderampuller.
Preotact is available in packs of 2 and 6 cartridges.
Preotactpennen og kanyler er ikke i pakningen med cylinderampullerne.
The Preotact pen and needles are not included.
Preotact injiceres ved hjælp af en injektionspen, der kan genbruges.
Preotact is injected using the re-usable pen, Preotact pen.
Indholdet i cylinderampullen blandes i Preotactpennen.
The contents of the dual-chamber cartridge is mixed in the Preotact pen.
Efter blanding skal opløsningen være klar og farveløs.
After mixing the liquid should be clear and colourless.
OPLØSNINGEN MÅ IKKE OMRYSTES; det kan ødelægge det virksomme lægemiddel.
DO NOT SHAKE; shaking may cause denaturation of the active substance.
Hvis opløsningen er uklar, farvet eller indeholder partikler efter blanding, skal cylinderampullen fjernes fra Preotactpennen og en ny skal sættes i.
If the mixed solution is cloudy, coloured or contains particles the cartridge should be removed from the Preotact pen and a new cartridge inserted.
Ubrugt medicin eller medicinaffald skal kasseres i overensstemmelser med retningslinier for medicinaffald.
Any unused product or waste material should be disposed of in accordance with local requirements.
Nycomed Danmark ApS Langebjerg 1 DK- 4000 Roskilde Denmark
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
EU/ 1/ 06/ 339/ 001- 002 11 9.
EU/1/06/339/001-002
Boehringer Gasse 5- 11 1211 Vienna Østrig
Boehringer Gasse 5-11 1211 Vienna Austria
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre det studie og de øvrige pharmacovigilanceaktiviteter, der er beskrevet detaljeret i Pharmacovigilance- Planen.
The Marketing Authorisation Holder commits to performing the study and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
ETIKETTERING
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
Outer Carton (2 and 6 dual-chamber cartridges)
Hver cylinderampul indeholder 1, 61 mg parathyreoideahormon.
Each dual-chamber cartridge contains 1.61 mg of parathyroid hormone..
Efter opløsning indeholder hver dosis på 71, 4 mikroliter 100 mikrogram parathyreoideahormon.
When the powder and the solvent have been mixed, each dose of 71.4 microliter contains 100 micrograms parathyroid hormone.
Natriumchlorid 0, 4%, mannitol, citronsyremonohydrat, saltsyre, metacresol, natriumhydroxid, vand til injektionsvæsker.
Sodium chloride 0.4%, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Hver cylinderampul indeholder 1, 61 mg parathyreoideahormon som pulver og 1, 13 ml solvens.
Each dual-chamber cartridge contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent.
2 stk. cylinderampuller.
2 dual-chamber cartridges per pack.
6 stk. cylinderampuller.
6 dual-chamber cartridges per pack.
Læs indlægssedlen inden brug.
Subcutaneous use Do not shake the reconstituted solution Read the package leaflet before use
EXP MM/ ÅÅÅÅ Færdigblandet opløsning:
16 EXP MM/YYYY Reconstituted solution:
28 dage.
28 days
Opbevar de ubrugte cylinderampuller i den ydre karton beskyttet mod lys.
Keep the cartridge in the outer carton in order to protect from light.
Færdigblandet opløsning:
Reconstituted solution:
Efter blanding kan cylinderampullen opbevares sammenlagt 7 dage ud af de 28 dages holdbarhed udenfor køleskab ved temperaturer under 25 °C.
Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark.
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark
EU/ 1/ 06/ 339/ 001 2 cylinderampuller pr. pakning.
EU/ 1/ 06/ 339/001 2 dual-chamber cartridges per pack.
EU/ 1/ 06/ 339/ 002 6 cylinderampuller pr. pakning.
EU/1/06/339/002 6 dual-chamber cartridges per pack.
CYLINDERAMPUL
Dual chamber cartridge
Preotact 100 mikrogram pulver og solvens til injektionsvæske, opløsning Parathyreoideahormon Subkutan anvendelse
Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone Subcutaneous use
1, 61 mg parathyreoideahormon og 1, 13 ml solvens (14 doser).
1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
20 INDLÆGSSEDDEL
INFORMATION FOR THE USER
- Kontakt din læge, sygeplejerske eller apoteket, hvis du har yderligere spørgsmål.
- If you have any further questions, ask your doctor or your pharmacist.
Giv det ikke videre til andre.
Do not pass it on to others.
dem, selv om de har samme symptomer som dig.
if their symptoms are the same as yours.
nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apoteket.
please tell your doctor or pharmacist.
Denne indlægsseddel fortæller 1.
1.
Hvad er Preotact, og hvad anvendes det til?
What Preotact is and what it is used for 2.
Hvad skal du gøre, før du anvender Preotact 3.
Before you use Preotact 3.
Hvordan anvender du Preotact 4.
How to use Preotact 4.
Hvordan opbevarer du Preotact 6.
Possible side effects 5 How to store Preotact 6.
HVAD ER PREOTACT, OG HVAD ANVENDES DET TIL?
WHAT PREOTACT IS AND WHAT IT IS USED FOR
Preotact bruges til at behandle knogleskørhed (osteoporose) hos kvinder efter overgangsalderen med høj risiko for knoglebrud.
Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Hvis du har knogleskørhed medfører det, at du er mere udsat for knoglebrud, især i ryg, hofter og håndled.
But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Knogleskørhed kan også forårsage rygsmerter, sammenfald i ryggen (højden formindskes), eller krum ryg.
It may also cause back pain, loss of height, and a curved back.
HVAD SKAL DU GØRE, FØR DU ANVENDER PREOTACT
BEFORE YOU USE PREOTACT
Anvend ikke Preotact hvis du • er allergisk overfor parathyreoideahormon eller et eller flere af de øvrige indholdsstoffer i Preotact. • har fået strålebehandling af knoglerne. • har for højt kalkindhold i blodet eller urinen eller andre forstyrrelser i din kalk - og fosfatbalance. • har en anden knoglesygdom (inklusive forøget produktion af parathyreoideahormon eller Pagets sygdom). • har et højt indhold af alkalisk fosfatase i blodet. • har en alvorlig nyresygdom. • har en alvorlig leversygdom.
Do not use Preotact: • if you are allergic (hypersensitive) to parathyroid hormone or any of the other ingredients of Preotact; • if you have had radiation therapy to the skeleton; • if you suffer from high calcium levels and other disturbances in the calcium-phosphor metabolism; • if you have other bone disease (including hyperparathyroidism or Paget’s disease); • if you have high levels of alkaline phosphatase; • if you suffer from severe kidney problems; • if you suffer from severe liver disease;
Måling af kalkindhold i blod og/ eller urin Din læge vil regelmæssigt kontrollere, hvordan behandlingen virker på dig.
Measuring of the calcium levels in the blood and/or urine
Der vil blive taget blod - og/ eller urinprøver 1, 3 og 6 måneder efter behandlingsstart.
He or she must perform blood and/or urine tests at month 1, 3 and 6 after starting your treatment with Preotact.
Vær særlig forsigtig med at anvende Preotact Preotact skal anvendes med forsigtighed, hvis du har eller har haft nyresten.
Preotact should be used with caution if you suffer from kidney stones or have had kidney stones.
Børn og unge Preotact må ikke anvendes til børn og unge.
Preotact should not be used in children or adolescents.
21 Ældre Der er ingen specielle forholdsregler.
Taking other medicines:
Anvendelse af anden medicin Fortæl altid lægen, hvis du bruger eller har brugt anden medicin for nylig.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Det gælder også medicin, der ikke er på recept, medicin købt i udlandet, naturmedicin samt stærke vitaminer og mineraler.
Preotact should be used with caution if you receive heart medicine.
Preotact skal anvendes med forsigtighed, hvis du er i behandling med hjertemedicin..
Taking Preotact with food and drink
Mad og drikke Mad eller drikke påvirker ikke virkningen af Preotact.
Food and drink have no influence on the effect of Preotact.