natgillin/translations-raw huggingface dataset:
- andre opioider, som indeholder lægemidler som f.eks. methadon, visse smertestillende midler og hostestillende medicin - antidepressiva, som bruges til behandling af depression, for eksempel isocarboxazid, phenelzin, selegilin, tranylcypromin og valproat, kan forstærke virkningen af dette lægemiddel.
other opioid containing medicines such as methadone, certain pain killers and cough suppressants anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
Du skal også straks informere din læge, hvis du får bivirkninger såsom:
Tell your doctor immediately or seek urgent medical attention if you experience side effects, such as:
- andre opioider, som indeholder lægemidler som f.eks. methadon, visse smertestillende midler og hostestillende medicin - antidepressiva, som bruges til behandling af depression, for eksempel isocarboxazid, phenelzin, selegilin, tranylcypromin og valproat kan forstærke virkningen af dette lægemiddel.
other opioid containing medicines such as methadone, certain pain killers and cough suppressants anti-depressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
Buprenorphin/naloxon er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see section 4.3 and 5.2).
• visse lægemidler (som bruges til behandling af svampeinfektioner) for eksempel ketoconazol og itraconazol, visse antibiotika, kan forstærke virkningen af dette lægemiddel.
• some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, certain antibiotics, may extend the effects of this medicine.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/359/003 8 mg sublinguale resoribletter 7
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/003 8 mg sublingual tablets 7
EU/1/06/359/004 8 mg sublinguale resoribletter 28
EU/1/06/359/004 8 mg sublingual tablets 28
• en nyresygdom
• any kidney disease
• visse lægemidler (som bruges til behandling af svampeinfektioner) for eksempel ketoconazol og itraconazol og visse antibiotika kan forstærke virkningen af dette lægemiddel.
• some antifungal agents (used to treat fungal infections) such as ketoconzaole, itraconazole, certain antibiotics may extend the effects of this medicine.
Hvis du får bivirkninger, skal du straks informere din læge eller omgående søge læge.
If you get any side effects, talk to your doctor.
Diarré Dyspepsi Flatulens Opkastning
Diarrhoea Dyspepsia Flatulence Vomiting
Bronkospasme Respirationsdepr ession
Bronchospasm Respiratory depression
4.5) og/eller patienter med eksisterende leverdysfunktion, har risiko for accelereret leverskade.
Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Hvis andre end den tilsigtede patient misbruger buprenorphin, er der yderligere risiko for, at nye stofafhængige bruger buprenorphin som det primære stof til deres misbrug.
Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft.
Hæmaturi
Urticaria
Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Forsigtighed tilrådes ved dosering til patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2).
Vandfri citronsyre Natriumcitrat
Citric acid anhydrous Sodium citrate
Suboxone 16 mg/4 mg sublinguale resoribletter er hvide, runde, bikonvekse resoribletter på 10,5 mm, præget med “N16” på den ene side.
Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16” debossed on one side.
Det kan forekomme hyppigere i de første uger af behandlingen, mens din dosis ændres.
This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Suboxone.
Forsigtighed tilrådes ved dosering til patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) (se pkt.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4 and 5.2).
Når der er opnået en tilfredsstillende stabilisering, kan doseringen med patientens samtykke trinvist nedsættes til en lavere vedligeholdelsesdosis.
After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Farmakokinetisk parameter
PK Parameter
Sådan skal du tage Suboxone
How to take Suboxone
Forstoppelse Kvalme
Constipation Nausea
Tal med lægen eller apoteket, hvis du har indtryk af, at effekten af Suboxone er for stærk eller for svag.
If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
For at undgå fremkaldelse af abstinenssymptomer bør administration af buprenorphin/naloxon først indledes, når der ses objektive tegn på abstinenser (se pkt.
To avoid precipitating withdrawal, induction with buprenorphine/naloxone should be undertaken when objective signs of withdrawal are evident (see section 4.2).
Magnesiumstearat Acesulfamkalium Naturlig citron- og limearoma.
Magnesium stearate Acesulfame potassium Natural lemon and lime flavour
Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Hvid, hexagonal, bikonveks resoriblet på 11 mm præget med “N8” på den ene side.
Sublingual tablet White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Hvid, hexagonal, bikonveks resoriblet på 6,5 mm præget med “N2” på den ene side.
Sublingual tablet White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Suboxone 2 mg/0,5 mg sublinguale resoribletter er hvide, sekskantede, hvælvede resoribletter på 6,5 mm, præget med “N2” på den ene side.
Suboxone 2 mg/0.5 mg sublingual tablets are white hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Suboxone 8 mg/2 mg sublinguale resoribletter er hvide, sekskantede, hvælvede resoribletter på11 mm, præget med “N8” på den ene side.
Suboxone 8 mg/2 mg sublingual tablets are white hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Hvid, rund, bikonveks resoriblet på 10,5 mm præget med “N16” på den ene side.
Sublingual tablet White round biconvex tablets of 10.5 mm with “N16” debossed on one side.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PAKNING MED 7 og 28 RESORIBLETTER 2 mg STYRKE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 2 mg STRENGTH
Hjælpestoffer, som behandleren skal være opmærksom på: Hver sublingual resoriblet indeholder 156,64 mg lactose (som monohydrat)
Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
INFORMATION I BRAILLE-SKRIFT Suboxone 2 mg/0,5 mg sublinguale resoribletter
INFORMATION IN BRAILLE Suboxone 2 mg/0.5 mg sublingual tablets
INFORMATION I BRAILLE-SKRIFT Suboxone 16 mg/4 mg sublinguale resoribletter
INFORMATION IN BRAILLE Suboxone 16 mg/4 mg sublingual tablets
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/359/001
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/001
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/359/003
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/003
Du må ikke synke eller indtage mad eller nogen form for drikkevarer, indtil resoribletten er helt opløst.
Do not swallow or consume food or any drink until the tablet is completely dissolved.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/359/005
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/005
Abdominalsmerte
Abdominal Pain
Den anbefalede startdosis til voksne og unge over 15 år er én til to Suboxone 2 mg/0,5 mg resoribletter.
The recommended starting dose in adults and adolescents over 15 years of age is one to two Suboxone 2 mg/0.5 mg. An additional one to two Suboxone 2 mg/0.5 mg may be administered on day one depending on the individual patient's requirement.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PAKNING MED 7 og 28 RESORIBLETTER 8 mg STYRKE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 8 mg STRENGTH
Hvis du holder op med at tage Suboxone
If you forget to take Suboxone
Hver 16 mg/4 mg sublingual resoriblet indeholder 16 mg buprenorphin (som hydrochlorid) og 4 mg naloxon (som hydrochloriddihydrat).
Each 16 mg/4 mg sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Hver 2 mg/0,5 mg sublingual resoriblet indeholder 2 mg buprenorphin (som hydrochlorid) og 0,5 mg naloxon (som hydrochloriddihydrat).
Each 2 mg/0.5 mg sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
INFORMATION I BRAILLE-SKRIFT Suboxone 8 mg/2 mg sublinguale resoribletter
INFORMATION IN BRAILLE Suboxone 8 mg/2 mg sublingual tablets
Naloxon Cmax
Cmax
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGER med 7 og 28 RESORIBLETTER 16 mg STYRKE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 16 mg STRENGTH
Indlægsseddel: Information til brugeren Suboxone 2 mg/0,5 mg sublinguale resoribletter buprenorphin/naloxon
Package leaflet: Information for the user Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine / naloxone
LÆGEMIDLETS NAVN Suboxone 16 mg/4 mg sublinguale resoribletter
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets
Indlægsseddel: Information til brugeren Suboxone 16 mg/4 mg sublinguale resoribletter buprenorphin/naloxon
Package leaflet: Information for the user Suboxone 16 mg/4 mg sublingual tablets buprenorphine / naloxone
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGER MED 7 og 28 RESORIBLETTER 8 mg STYRKE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 8 mg STRENGTH
Hepatitis Akut hepatitis Gulsot
Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Reckitt Benckiser Healthcare (UK) Ltd Dansom Lane
Name and address of the manufacturer responsible for batch release Reckitt Benckiser Healthcare (UK) Ltd
Indlægsseddel: Information til brugeren Suboxone 8 mg/2 mg sublinguale resoribletter buprenorphin/naloxon
Package leaflet: Information for the user Suboxone 8 mg/2 mg sublingual tablets buprenorphine / naloxone
Hver sublingual resoriblet indeholder 2 mg buprenorphin (som hydrochlorid) og 0,5 mg naloxon (som hydrochloriddihydrat).
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Hver 8 mg/2 mg sublingual resoriblet indeholder 8 mg buprenorphin (som hydrochlorid) og 2 mg naloxon (som hydrochloriddihydrat).
Each 8 mg/2 mg tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
LÆGEMIDLETS NAVN Suboxone 2 mg/0,5 mg sublinguale resoribletter
NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets
• Abstinenssymptomer
• Withdrawal symptoms
LÆGEMIDLETS NAVN Suboxone 8 mg/2 mg sublinguale resoribletter
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets
Hver sublingual resoriblet indeholder 16 mg buprenorphin (som hydrochlorid) og 4 mg naloxon (som hydrochloriddihydrat).
Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Lad være med at indtage mad eller drikkevarer, indtil resoribletterne er opløst helt.
Do not consume any food or drink until the tablets have completely dissolved
Vægttab, hævede hænder og fødder, døsighed, angst, nervøsitet, prikkende fornemmelse, depression, nedsat seksualdrift, øget muskelspænding, unormale tanker, øget tåreflåd (øjne, der løber i vand) eller på anden måde ændret tåreflåd, sløret syn, blussen, forhøjet blodtryk, migræne, løbende næse, ondt i halsen og smerte ved synkebevægelse, øget hoste, oprørt mave eller anden mavebesvær, diarré, unormal leverfunktion, luftafgang fra tarmen, opkastning, udslæt, kløe, nældefeber, smerte, ledsmerter, muskelsmerter, kramper i benene (muskelkramper), impotens, unormal urin, mavesmerter, rygsmerter, svaghed, infektion, kuldegysninger, brystsmerter, feber, influenzalignende symptomer, generelt ubehag, utilsigtet tilskadekomst som følge af manglende årvågenhed eller koordinationsevne, mathed og svimmelhed.
Weight loss, swelling (hands and feet), drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, increase in muscle tension, abnormal thinking, increased tearing (watering eyes) or other tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach or other stomach discomfort, diarrhoea, abnormal liver function, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps (muscle spasm), difficulty in getting or keeping an erection, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, feeling of general discomfort, accidental injury caused by loss of alertness or co-ordination, faintness and dizziness.
Hver sublingual resoriblet indeholder 8 mg buprenorphin (som hydrochlorid) og 2 mg naloxon (som hydrochloriddihydrat).
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
LÆGEMIDLETS NAVN Suboxone 16 mg/4 mg sublinguale resoribletter buprenorphin/naloxon
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets buprenorphine / naloxone
Agitation Apati
Abnormal dreams Agitation Apathy
1,1-folds stigning
1.1-fold Increase
Hepatitis galdeveje
Hepatic impairment
Det skal du vide, før du begynder at tage Suboxone Sådan skal du tage Suboxone Bivirkninger
What Suboxone is and what it is used for What you need to know before you take Suboxone How to take Suboxone
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGER med 7 og 28 RESORIBLETTER 2 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 2 mg STRENGTH
Lægemiddelafh ængighed Eufori
Depersonalisation Drug dependence Euphoric mood Hostility
EU/1/06/359/005 16 mg sublinguale resoribletter 7 EU/1/06/359/006 16 mg sublinguale resoribletter 28
EU/1/06/359/006 16 mg sublingual tablets 28
EU/1/06/359/001 2 mg sublinguale resoribletter 7 EU/1/06/359/002 2 mg sublinguale resoribletter 28
EU/1/06/359/002 2 mg sublingual tablets 28
Fremkaldelse af opioid-abstinenssyndrom
Precipitation of opioid withdrawal syndrome
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver resoriblet indeholder 2 mg buprenorphin (som hydrochlorid) og 0,5 mg naloxon (som hydrochloriddihydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
LÆGEMIDLETS NAVN Suboxone 8 mg/2 mg sublinguale resoribletter buprenorphin/naloxon
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets buprenorphine/naloxone
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver resoriblet indeholder 16 mg buprenorphin (som hydrochlorid) og 4 mg naloxon (som hydrochloriddihydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Hver sublingual resoriblet indeholder 42 mg lactose (som monohydrat)
Each sublingual tablet contains 42 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Yderligere én til to Suboxone 2 mg/0,5 mg resoribletter kan gives på dag 1, afhængigt af dit behov.
The recommended starting dose for adults and adolescents over the age of 15 years is one to two tablets of Suboxone 2 mg/0.5 mg. An additional one to two tablets of the Suboxone 2 mg/0.5 mg may be administered on day 1 depending on your needs.
LÆGEMIDLETS NAVN Suboxone 2 mg/0,5 mg sublinguale resoribletter buprenorphin/naloxon
NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine / naloxone
Hjælpestoffer, som behandleren skal være opmærksom på: Hver sublingual resoriblet indeholder 168 mg lactose (som monohydrat)
Each sublingual tablet contains 168 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
0,2-folds stigning
0.2-fold decrease
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): Hævede lymfekirtler, ophidselse, rysten, unormale drømme, overdreven muskelaktivitet, personlighedsændring (følelse af ikke at være sig selv), medicinafhængighed, amnesi (hukommelsestab), manglende interesse, overdreven følelse af velbehag, kramper (krampeanfald), taleforstyrrelser, små pupiller, vandladningsproblemer, betændelse eller infektion i øjet, hurtig eller langsom puls, lavt blodtryk, hjertebanken, myokardieinfarkt (hjerteanfald), snørende fornemmelse omkring brystkassen, stakåndethed, astma, gabning, smerte og sår i munden, misfarvning af tungen, akne, knopper i huden, hårtab, tør eller afskallende hud, betændelse i led, urinvejsinfektion, unormale blodværdier, blod i urinen, unormal ejakulation, menstruationsproblemer eller lidelser i skeden, nyresten, protein i din urin, smertefuld eller vanskelig vandladning, følsomhed overfor varme og kulde, hedeslag, appetitløshed, fjendtlighedsfølelse.
Swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, protein in your urine, painful or difficult urination, sensitivity to heat or cold, heat stroke, loss of appetite, feelings of hostility.
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): Hævede lymfekirtler, ophidselse, rysten, unormale drømme, overdreven muskelaktivitet, personlighedsændring (følelse af ikke at være sig selv), medicinafhængighed, amnesi (hukommelsestab), manglende interesse, overdreven følelse af velbehag, kramper (krampeanfald), taleforstyrrelser, små pupiller, vandladningsproblemer, betændelse eller infektion i øjet, hurtig eller langsom puls, lavt blodtryk, hjertebanken, myokardieinfarkt (hjerteanfald), snørende fornemmelse omkring brystkassen, stakåndethed, astma, gaben, smerte og sår i munden, misfarvning af tungen, akne, knuder i huden, hårtab, tør eller afskallende hud, betændelse i led, urinvejsinfektion, unormale blodværdier, blod i urinen, unormal ejakulation, menstruationsproblemer eller gener fra skeden, nyresten, protein i din urin, smertefuld eller vanskelig vandladning, følsomhed over for varme og kulde, hedeslag, appetitløshed fjendtlighedsfølelse.
Swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, protein in your urine, painful or difficult urination, sensitivity to heat or cold, heat stroke, loss of appetite feelings of hostility.
Sikkerhedsforanstaltninger før administration af lægemidlet
Precautions to be taken before induction
Hyperkinesi Kramper Taleforstyrrelser Tremor
Speech disorder Tremor
Akut hepatitis Gulsot
Severe hepatic impairment
Hovedpine
Injury
Mave-tarmkanalen
Maize starch
• Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Abstinenssyndro
Heat stroke
MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Tube (alu)
Cutaneous use tube (alu) 2 g
Pakningsstørelse
Name
Hvis symptomerne varer længere end en uge, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
If symptoms last longer than one week a doctor or a qualified healthcare practitioner should be consulted.
Lægemidler med padderok, bør kun anvendes til voksne og unge over 12 år.
Horsetail herb medicines should be used only in adults and adolescents over the age of 12 years.
Padderok er fællesnavnet for de overjordiske dele af planten Equisetum arvense L.
Horsetail herb is the common name for the aerial parts of the plant Equisetum arvense L.
Hvad er padderokke?
What is horsetail herb?
Ansøgninger om godkendelse af lægemidler, der indeholder padderok, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
Any applications for the licensing of medicines containing horsetail herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Selvom resultaterne fra denne undersøgelse tyder på, at padderok i denne tilberedning faktisk har en mild vanddrivende virkning, omfattede undersøgelsen kun få forsøgspersonerog oplysningerne om den anvendte tilberedning var begrænsede.
Although the results from this study indicated that the horsetail herb preparation did have a mild diuretic effect, only a few individuals were included in the study and the information on the preparation used was limited.
Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder padderok, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
Information on the use and licensing of horsetail herb medicines in EU Member States should be obtained from the relevant national authorities.
EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder padderok.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing horsetail herb.
Tilberedninger af padderok kan også anvendes til behandling af overfladiske sår.
Horsetail herb preparations can also be used for treating superficial wounds.