natgillin/translations-raw huggingface dataset:
INVEGA bør anvendes med forsigtighed til ældre patienter med demens og samtidig risiko for slagtilfælde (se pkt.
INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4).
Hvis dosisøgning er indiceret, anbefales trin à 3 mg/dag, og intervallet bør generelt være på mere end 4 dage.
When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 4 days.
Hos unge, der vejer 51 kg eller derover, kan dosis øges til mellem 6 mg til 12 mg en gang dagligt.
For adolescents weighing 51 kg or more the dose may be increased within the range of 6 mg to 12 mg once a day.
INVEGAs sikkerhed og virkning ved behandling af skizofreni hos unge i alderen 12 til 14 er ikke klarlagt.
The safety and efficacy of INVEGA in the treatment of schizophrenia in adolescents between 12 and 14 years old has not been established.
I alle studier og for alle INVEGA-doser var EPS hyppigere hos unge end hos voksne.
Across all adolescent studies, EPS was more common in adolescents than in adults for each INVEGA dose.
Ændring i PANSS-score ved 8. uge, akut endepunkt Gennemsnitlig baseline (SD) Gennemsnitlig ændring (SD) P-værdi (vs. aripiprazol) Forskel i gennemsnitlig LS (SE) Ændring i PANSS-score ved 26. uges endepunkt Gennemsnitlig baseline (SD) Gennemsnitlig ændring (SD) P-værdi (vs. aripiprazol) Forskel i gennemsnitlig LS (SE)
Change in PANSS Score 26 week endpoint Mean baseline (SD) Mean change (SD) P-value (vs aripiprazole) Diff. of LS Means (SE) Responder Analysis 26 week endpoint Responder, n (%) Non-responder, n (%) P value (vs aripiprazole)
• nedbrydelse af muskelfibre og muskelsmerter (rabdomyolyse), unormal kropsholdning
• breakdown of muscle fibers and pain in muscles (rhabdomyolysis), abnormal posture
• atrieflimren (unormal hjerterytme), hurtig hjerterytme, når du har rejst dig op
• atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing
3 mg tabletter Indeholder laktose.
3 mg tablets Contains lactose.
Glaukom, forstyrrede øjenbevægelser c,
conjunctivitis, dry eye glaucoma, eye movement disorder c,
Til patienter med moderat til svært nedsat nyrefunktion (kreatininclearance ≥ 10 og < 50 ml/min) er den anbefalede startdosis af INVEGA 3 mg hver anden dag.
For patients with moderate to severe renal impairment (creatinine clearance  10 to < 50 mL/min), the recommended initial dose of INVEGA is 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment.
Hvid PVC (polyvinylchlorid) lamineret med PCTFE (polychlortrifluorethylen)/bagside af perforerbart aluminium.
White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Meget almindelige bivirkninger: forekommer hos mere end 1 ud af 10 personer
Very common: may affect more than 1 in 10 people
Derfor er bivirkningsprofilen for disse stoffer (herunder både den orale og injicerbare formulering) relevant for hinanden.
Undesirable effects noted with risperidone formulations Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another.
Studie hos unge med skizofreni: R076477-PSZ-3001: 6-ugers, fast dosis, placebo-kontrolleret Intent-to-Treat-analysesæt.
Adolescent Schizophrenia Study: R076477-PSZ-3001: 6-week, fixed-dose, placebo-controlled Intent-to-Treat Analysis Set.
INVEGA anvendes til behandling af skizofreni hos voksne og unge i alderen 15 år og derover.
INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older.
• mavesmerter, ubehag i maven, opkastning, kvalme, forstoppelse, diarré, fordøjelsesbesvær,
• abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion,
• lungebetændelse på grund af fejlsynkning af mad, tilstopning af luftvejene, ændret stemme
• pneumonia caused by inhaling food, congestion of breathing passages, voice disorder
• hvis du har en forstyrrelse i svælget, maven eller tarmene, som betyder, at du har vanskeligt ved at synke eller fordøje føde.
- if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
PVC (polyvinylchlorid) lamineret med PCTFE (polychlortrifluorethylen)/bagside af perforerbart aluminium.
Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Ved vurdering af behandlingsbehov og restitution bør produktets depotformulering tages i betragtning.
Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery.
Eftersom INVEGA ikke er undersøgt hos patienter med svært nedsat leverfunktion, bør der udvises forsigtighed ved brug af INVEGA til denne patientgruppe.
As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
QT-interval i elektrokardiogrammet, bradykardi, takykardi,
Cardiac disorders atrioventricular block, conduction disorder, electrocardiogra m QT prolonged, bradycardia,
• opsvulmet tunge, mave- eller tarminfektion, synkebesvær, øget luftafgang fra tarmen
• swollen tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas or wind
Man., Tirs., Ons., Tors., Fre., Lør., Søn.
Mon, Tue, Wed, Thu, Fri, Sat, Sun
Hyperhydrering, diabetisk ketoacidose c, hypoglykæmi, polydipsi, forhøjet kolesterol i blodet
waist circumference increased, anorexia, blood triglycerides increased water intoxication, diabetic ketoacidosis c, hypoglycaemia, polydipsia, blood cholesterol increased hyperinsulinaemi
4.4) ses en additiv effekt, når INVEGA indgives sammen med andre lægemidler med dette potentiale, f.eks. andre antipsykotika eller tricykliske antidepressiva.
Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
• blodtryksfald efter at have rejst sig op (derfor kan nogle personer, som tager INVEGA, føle, at de skal besvime, være svimle eller besvime, hvis de rejser sig eller sætter sig op pludseligt), højt blodtryk
dizzy, or may pass out when they stand up or sit up suddenly), high blood pressure
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENT
Brug af anden medicin sammen med INVEGA
Other medicines and INVEGA
Celluloseacetat
Cellulose acetate
De hyppigst rapporterede bivirkninger i de kliniske studier med voksne var hovedpine, søvnløshed, sedation/ døsighed, parkinsonisme, akatisi, takykardi, tremor, dystoni, infektion i de øvre luftveje, angst, svimmelhed, vægtøgning, kvalme, agitation, obstipation, opkastning, træthed, depression, dyspepsi, diarré, mundtørhed, tandpine, muskuloskeletale smerter, hypertension, asteni, rygsmerter, forlænget QT-interval i elektrokardiogrammet samt hoste.
The adverse drug reactions (ADRs) most frequently reported in clinical trials with adults were headache, insomnia, sedation/somnolence, parkinsonism, akathisia, tachycardia, tremor, dystonia, upper respiratory tract infection, anxiety, dizziness, weight increased, nausea, agitation, constipation, vomiting, fatigue, depression, dyspepsia, diarrhoea, dry mouth, toothache, musculoskeletal pain, hypertension, asthenia, back pain, electrocardiogram QT prolonged, and cough.
BLISTERKORT AF PVC-PTFE/ALUMINIUM MED 7 ELLER 10 TABLETTER (for hvide og klare blisterkort)
7 & 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)
14 depottabletter 28 depottabletter 49 depottabletter 56 depottabletter 98 depottabletter
14 prolonged-release tablets 28 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
Hvis dosisøgning er indiceret, anbefales dosisøgninger på 3 mg/dag, og intervallet bør generelt være længere end 5 dage.
When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.
Beholdere:
Blisters:
Jernoxid (sort) (E172) Propylenglycol Hypromellose
Iron oxide (Black) (E172) Propylene glycol Hypromellose
Den anbefalede dosis af INVEGA til behandling af skizofreni hos voksne er 6 mg en gang dagligt administreret om morgenen.
The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning.
• bronkitis, forkølelsessymptomer, bihulebetændelse, urinvejsinfektion, influenza-lignende symptomer
• infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary tract infection, feeling like you have the flu
• brystudvikling hos mænd, forstørrede brystkirtler, flåd fra brysterne, udflåd fra skeden
• development of breasts in men, enlargement of the glands in your breasts, discharge from the breasts, vaginal discharge
Gennemsnitlig ændring (SD) P-værdi (vs. placebo) Forskel i gennemsnitlig LS (SE)
Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Skizofreni-studier: Andelen af forsøgspersoner med Responder-status ved LOCF-endepunkt Studierne R076477-SCH-303, R076477-SCH-304 og R076477-SCH-305: Intent-to-Treat-analysesæt Placebo INVEGA 3 mg
Schizophrenia Studies: Proportion of Subjects with Responder Status at LOCF End Point Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Vertigo, tinnitus, øresmerter
Ear and labyrinth disorders vertigo, tinnitus, ear pain
Symptomer på forhøjet prolaktin kan omfatte: Hos mænd: brystforstørrelse, problemer med at få eller opretholde erektion eller anden seksuel dysfunktion.
When symptoms of high prolactin occur, they may include: (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.
14 depottabletter 28 depottabletter 30 depottabletter 49 depottabletter 56 depottabletter 98 depottabletter
14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
Skizofreni: Den anbefalede startdosis af INVEGA til behandling af skizofreni hos unge over 15 år er 3 mg en gang dagligt om morgenen.
Schizophrenia: The recommended starting dose of INVEGA for the treatment of schizophrenia in adolescents 15 years and older is 3 mg once daily, administered in the morning.
• forsinket menstruation, brystforstørrelse
• a delay in menstrual periods, breast enlargement
Psykiske forstyrrelser: søvnrelateret spiseforstyrrelse Nervesystemet: cerebrovaskulær lidelse
Psychiatric disorders: sleep-related eating disorder Nervous system disorders: cerebrovascular disorder Eye disorders: floppy iris syndrome (intraoperative) Respiratory, thoracic and mediastinal disorders: rales
Hvis du har taget for meget INVEGA
If you take more INVEGA than you should
Baseret på in vitro-studier med humane leverenzymer er paliperidon ikke et substrat for CYP1A2.
Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Pneumoni, luftvejsinfektion, cystitis, infektion i øret, tonsillitis
• pneumonia, infection of the breathing passages, bladder infection, ear infection, tonsillitis
Pankreatitis c, tarmobstruktion, ileus, fækalinkontinens, fækalom c, cheilitis
intestinal obstruction, ileus, faecal incontinence, faecaloma c, cheilitis
Den anbefalede dosis af INVEGA til behandling af skizo-affektiv psykose hos voksne er 6 mg en gang dagligt administreret om morgenen.
The recommended dose of INVEGA for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning.
Erektil dysfunktion, ejakulationsforstyrrelse, menstruationsforstyrrelse e, galaktorré, seksuel dysfunktion, smerter i brysterne, ubehag i brysterne
ejaculation disorder, menstrual disorder e, galactorrhoea, sexual dysfunction, breast pain, breast discomfort priapism c, menstruation delayed gynaecomastia, breast engorgement,
Angioødem, medicinudslæt c, hyperkeratose, tør hud, erytem, misfarvning af huden, seborisk dermatitis, skæl
Skin and subcutaneous tissue disorders pruritus, rash urticaria, alopecia, eczema, acne angioedema, drug eruption c, hyperkeratosis, dry skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff
• højt niveau af triglycerider (fedtstoffer) i blodet
• high blood triglycerides (a fat)
INVEGA 3 mg depottabletter INVEGA 6 mg depottabletter INVEGA 9 mg depottabletter INVEGA 12 mg depottabletter paliperidon
INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets paliperidone
Polyethylenglycol 3350
Hydroxyethyl Cellulose Polyethylene glycol 3350
• nældefeber, hårtab, eksem, acne
• hives (or “nettle rash”), hair loss, eczema, acne
• blodpropper i blodårerne (venerne), især i benene (symptomerne omfatter hævelse, smerte og rødme i benet).
• experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Opsvulmet tunge, gastroenteritis, dysfagi, flatulens
dyspepsia, dry mouth, toothache swollen tongue, gastroenteritis, dysphagia,
Malignt neuroleptikasyndrom, cerebral iskæmi, manglende respons på stimuli c,
disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paresthaesia neuroleptic malignant syndrome, cerebral ischaemia, unresponsive to stimuli c, loss of consciousness, depressed level of consciousness c,
INVEGA er ikke beregnet til behandling af skizo-affektiv psykose hos børn og unge under 18 år.
INVEGA is not for use in children and adolescents who are under 18 years for the treatment of schizoaffective disorder.
Den anbefalede startdosis til behandling af skizofreni hos unge på 15 år eller derover er 3 mg en gang dagligt om morgenen.
The recommended starting dose for treating schizophrenia in adolescents 15 years and older is 3 mg once a day taken in the morning.
Hold beholderen tæt tillukket for at beskytte mod fugt
Do not store above 30 Keep the bottle tightly closed in order to protect from moisture
Studier hos patienter med skizo-affektiv psykose: Sekundært virkningsparameter, Andel af forsøgspersoner med Responder Status ved LOCF-endepunkt: Studierne R076477-SCA-3001 og R076477-SCA-3002: Intent-to-Treat-analysesæt
Schizoaffective Disorder Studies: Secondary Efficacy Parameter, Proportion of Subjects with Responder Status at LOCF End Point: Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Effekt blev også vurderet ved beregning af behandlingsrespons (defineret som reduktion i samlet PANSS-score ≥ 30 %) som et sekundært endepunkt.
In all three studies, INVEGA was superior to placebo on PSP and CGI-S. Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30%) as a secondary endpoint.
BLISTERKORT AF OPA-ALUMINIUM-PVC/ALUMINIUM MED 7 TABLETTER
7 TABLET OPA-ALU-PVC/ALU BLISTER
INVEGA 3 mg depottabletter INVEGA 6 mg depottabletter INVEGA 9 mg depottabletter INVEGA 12 mg depottabletter
INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets
Pruritus, udslæt
vomiting, nausea,
Børnesikkert blisterkort af OPA (orienteret polyamid)-aluminium-PVC (polyvinylchlorid)/perforerbart aluminium.
Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.
mundtørhed, tandpine
dry mouth, toothache
Tardiv dyskinesi, krampeanfald e,
tremor tardive dyskinesia,
• hvis du tidligere har fået stillet diagnosen malignt neuroleptikumsyndrom (høj temperatur og muskelstivhed).
- if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
Hver INVEGA 9 mg depottablet indeholder 9 mg paliperidon.
Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone.
manglende respons på stimuli, lavt bevidsthedsniveau, hovedrysten
low level of consciousness, shaking of the head
Studier hos patienter med skizo-affektiv psykose: Primær virkningsparameter, ændring i samlet PANSS-score i forhold til baseline i studierne R076477-SCA-3001 og R076477-SCA-3002: Intent-to-Treat-analysesæt
Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Carnubavoks
Paliperidone
Butylhydroxytoluen (E321) Jernoxid (gul) E172 (kun 3 mg og 12 mg tabletter) Polyethylenoxid 7000K
Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172)
Skizofreni-studier: Samlet PANSS-score - ændring fra baseline til effektmål - LOCF for studierne R076477-SCH-303, R076477-SCH-304 og R076477-SCH-305: intent-to-treat-analysesæt Placebo INVEGA 3 mg
Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point - LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Jernoxid (rød) (E172)
Printing ink Iron oxide (black) (E172)
Hver depottablet indeholder 9 mg paliperidon.
Each prolonged-release tablet contains 9 mg of paliperidone.
Kapselformede beige tabletter, der består af tre lag og er 11 mm lange og 5 mm i diameter, med teksten ”PAL 6”
Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”
Søvnforstyrrelser, forvirringstilstand, nedsat libido, anorgasme, nervøsitet, mareridt
confusional state, libido decreased, anorgasmia, nervousness, nightmare catatonia, somnambulism, blunted affect
Hypromellose Titandioxid (E171) Polyethylenglycol 400 Jernoxid (rød) (E172) Carnaubavoks
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (red) (E172) Carnauba wax
Hver INVEGA 12 mg depottablet indeholder 12 mg paliperidon.
Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
Titandioxid (E171) Polyethylenglycol 400 Jernoxid (gul) (E172) Carnaubavoks
Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Carnauba wax
Mave-tarmkanalen
BOTTLE CARTON
Skizo-affektiv psykose
Schizoaffective disorder
Hver INVEGA 6 mg depottablet indeholder 6 mg paliperidon.
Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
• ondt i halsen, hoste, stoppet næse
• sore throat, cough, stuffy nose
Hver depottablet indeholder 12 mg paliperidon.
Each prolonged-release tablet contains 12 mg of paliperidone.
- Beholdere: Tabletterne udleveres i en plastbeholder med børnesikret låg.
- Bottles: The tablets are supplied in a plastic bottle with a child-resistant plastic cap. Each bottle contains either 30 tablets or 350 tablets.
Hver INVEGA 3 mg depottablet indeholder 3 mg paliperidon.
Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Pulmonal kongestion
• lung congestion
Abstinenssyndrom c, induration
ischaemia, flushing
Natriumindhold
Printing ink
Hver depottablet indeholder 3 mg paliperidon.
Each prolonged-release tablet contains 3 mg of paliperidone.
Sådan skal du tage INVEGA
How to take INVEGA
30 depottabletter - EU/1/07/395/057 350 depottabletter - EU/1/07/395/058
30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Hver depottablet indeholder 6 mg paliperidon.
Each prolonged-release tablet contains 6 mg of paliperidone.
30 depottabletter - EU/1/07/395/063 350 depottabletter - EU/1/07/395/064
30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
bevidsthedstab, nedsat bevidsthedsniveau c, diabetisk koma c, balanceforstyrrelse, unormal koordination, rytmisk rokkebevægelse af hovedet
diabetic coma balance disorder, coordination abnormal, head titubation
30 depottabletter - EU/1/07/395/061 350 depottabletter - EU/1/07/395/062
30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Forhøjet kreatinkinase i blodet, muskelspasmer, stivhed i leddene, hævede led, muskelsvaghed, nakkesmerter
Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Blodpropper kan løsrives og føres med blodet til lungerne, hvor de kan forårsage brystsmerter og åndedrætsbesvær.
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
30 depottabletter - EU/1/07/395/059 350 depottabletter - EU/1/07/395/060
30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
P-værdi (vs. aripiprazol)
EXP MM/YYYY
Blæk:
Printing ink:
14 depottabletter - EU/1/07/395/074 - KLARE 28 depottabletter - EU/1/07/395/016 - KLARE 30 depottabletter - EU/1/07/395/017 - KLARE 49 depottabletter - EU/1/07/395/018 - KLARE 56 depottabletter - EU/1/07/395/019- KLARE 98 depottabletter - EU/1/07/395/020- KLARE
14 prolonged-release tablets - EU/1/07/395/074 - CLEAR 28 prolonged-release tablets - EU/1/07/395/016 - CLEAR 30 prolonged-release tablets - EU/1/07/395/017 - CLEAR 49 prolonged-release tablets - EU/1/07/395/018 - CLEAR 56 prolonged-release tablets - EU/1/07/395/019 - CLEAR 98 prolonged-release tablets - EU/1/07/395/020 - CLEAR
Tabletkerne:
Bottles:
14 depottabletter - EU/1/07/395/070 28 depottabletter - EU/1/07/395/045 49 depottabletter - EU/1/07/395/046 56 depottabletter - EU/1/07/395/047 98 depottabletter - EU/1/07/395/048
14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
• betændelse i bugspytkirtlen
• inflammation of the pancreas
Bronkitis, infektioner i øvre luftveje, sinusitis, urinvejsinfektion, influenza
Infections and infestations bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, influenza pneumonia, respiratory tract infection, cystitis, ear infection, tonsillitis eye infection, onychomycosis, cellulitis, acarodermatitis
14 depottabletter - EU/1/07/395/071 - KLARE 28 depottabletter - EU/1/07/395/011 - KLARE 30 depottabletter - EU/1/07/395/012 - KLARE 49 depottabletter - EU/1/07/395/013 - KLARE 56 depottabletter - EU/1/07/395/014- KLARE 98 depottabletter - EU/1/07/395/015- KLARE
14 prolonged-release tablets - EU/1/07/395/071 - CLEAR 28 prolonged-release tablets - EU/1/07/395/011 - CLEAR 30 prolonged-release tablets - EU/1/07/395/012 - CLEAR 49 prolonged-release tablets - EU/1/07/395/013 - CLEAR 56 prolonged-release tablets - EU/1/07/395/014 - CLEAR 98 prolonged-release tablets - EU/1/07/395/015 - CLEAR
14 depottabletter - EU/1/07/395/075 - HVIDE 28 depottabletter - EU/1/07/395/036- HVIDE 30 depottabletter - EU/1/07/395/037 - HVIDE 49 depottabletter - EU/1/07/395/038- HVIDE 56 depottabletter - EU/1/07/395/039 - HVIDE 98 depottabletter - EU/1/07/395/040 - HVIDE
14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE