natgillin/translations-raw huggingface dataset:
Cytokrom P450 CYP2C9- aktivitet er nedsat hos personer med genetisk polymorfisme, som fører til nedsat enzymaktivitet, som f. eks. homozygot ved CYP2C9* 3- polymorfisme.
Cytochrome P450 2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
I et farmakokinetisk forøg med celecoxib 200 mg indgivet 1 gang dagligt til raske frivillige forsøgspersoner med genotype CYP2C9* 1 / * 1, CYP2C9* 1 / * 3 eller CYP2C9* 3 / * 3 er median Cmax og AUC0- 24 for celecoxib på dag 7 henholdsvis ca. firedoblet og syvdoblet hos personer med genotype CYP2C9* 3 / * 3 sammenlignet med andre genotyper.
In a pharmacokinetic study of celecoxib 400 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/ *1, CYP2C9*1/ *3, or CYP2C9*3/ *3, the median Cmax and AUC 0-24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/ *3 compared to other genotypes.
I 3 separate enkeltdosisforsøg, der omfattede i alt 5 forsøgspersoner med genotype CYP2C9* 3 / * 3, øges enkeltdosis AUC0- 24 ca.
In three separate single dose studies, involving a total of 5 subjects genotyped as
3 gange sammenlignet med personer med normal metabolisme.
23 CYP2C9*3/ *3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolizers.
27 I et 2- årigt toksicitetsforsøg er der set øget nonadrenal thrombose hos han- rotter ved høje doser.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Mærkningsblækket indeholder: shellac propylenglycol jernoxid (E172) Brilliant Blue FCF (E133)
24 Printing ink contains: shellac propylene glycol iron oxide (E172)
Uigennemsigtig PVC/ aluminiumfolieblister.
Opaque PVC/ Aclar/ Aluminium foil blisters.
17. oktober 2003.
17 October 4003
29 BILAG II
25 ANNEX II
• Pfizer Manufacturing Deutschland GmbH, Heinrich- Mack- Strasse 35, 89257 Illertissen, Tyskland
• Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany
SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme afslutte forsøg i henhold til nedennævnte oversigt.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre forsøget ” Phase III Placebo - controlled Trial with Celecoxib in Genotype Positive Subjects with Familial Adenomatous Polyposis ” (A3191193 – CHIP- forsøg) for at fremskaffe yderligere sikkerheds - og effektdata.
The MAH commits to undertake a “ Phase III Placebo-controlled Trial with Celecoxib in Genotype Positive Subjects with Familial Adenomatous Polyposis” (A3191193 – CHIP trial )” to generate further efficacy and safety data.
Indehaveren af markedsføringstilladelsen vil indsende en statusrapport omfattende en opdatering af sikkerhedsinformation på forsøg A3191193 – CHIP- forsøget hvert år i forbindelse med den årlige revurdering.
The MAH will submit all progress reports and all safety data within the fifth Annual Re- assessment/ Renewal.
Indehaveren af markedsføringstilladelsen vil indsende den endelige forsøgsrapport så snart denne er tilgængelig.
The MAH will submit the full report when available..
31 Bilag III ETIKETTERING OG INDLÆGSSEDDEL
LABELLING AND PACKAGE LEAFLET
33 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
INFORMATION OM BRAILLE- SKRIFT
INFORMATION IN BRAILLE
35 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Lactose Se indlægssedlen for yderligere information.
See leaflet for further information.
Batch
BATCH NUMBER Batch {number}
37 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
39 10.
35 10.
40 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
42 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 B.
39 B.
44 INDLÆGSSEDDEL:
40 PACKAGE LEAFLET:
kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
symptoms are the same as yours.
Virkning og anvendelse 2.
What Onsenal is and what it is used for 2.
Det skal du vide, før du begynder at tage Onsenal 3.
How to take Onsenal 4.
Sådan skal du tage Onsenal 4.
Possible side effects 5.
Bivirkninger 5 Opbevaring 6 Yderligere oplysninger
Further information
VIRKNING OG ANVENDELSE
WHAT ONSENAL IS AND WHAT IT IS USED FOR
Onsenal tilhører en medicingruppe, som kaldes cyklooxygenase- 2- hæmmere (COX- 2).
Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.
Cyklooxygenase- 2 er et enzym, som øges på steder med betændelse og i celler, der vokser unormalt.
Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells.
Onsenal virker ved at hæmme COX- 2, og dette påvirker betændte og unormalt voksende celler.
Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive.
Onsenal bruges til at reducere antallet af mave - og tarmpolypper hos patienter med familiær adenomatøs polypose (FAP).
Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP).
FAP er en arvelig sygdom, hvor endetarm og tyktarm er dækket med mange polypper, som kan udvikle sig til endetarms - eller tyktarmskræft.
FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer..
Onsenal bør bruges sammen med den sædvanlige behandling til FAP- patienter, såsom kirurgi og endoskopisk kontrol.
Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ONSENAL
BEFORE YOU TAKE ONSENAL
Tag ikke Onsenal:
Do not take ONSENAL
- hvis du er overfølsom (allergisk) over for et af indholdsstofferne i Onsenal.
- if you have had an allergic reaction to any of the ingredients of Onsenal
- hvis du er overfølsom (allergisk) over for den type medicin som kaldes sulfonamider.
- if you have had an allergic reaction to a group of medicines called “ sulphfonamides”.
Disse
These include
omfatter visse antibiotika (Bactrim og Septra, som begge er en kombination af sulfamethoxazol og trimetoprim), som bruges ved behandling af infektioner.
some antibiotics (Bactrim and Septra used in combination of sulfamethoxazole and trimethoprim), which can be used to treat infections
- hvis du har mavesår eller sår på tolvfingertarmen eller bløder i maven eller tarmene
- if you have a stomach or duodenal ulcer, or bleeding in the stomach or intestines
- hvis du – efter at have taget acetylsalicylsyre eller anden antiinflammatorisk medicin - har
- if after taking aspirin or another anti-inflammatory medicine you have had nasal polyps or severe
fået næsepolypper eller svær tillukning af næsen eller en overfølsomhedsreaktion som f. eks. kløende hududslæt, hævelse, besværet eller hvæsende vejrtrækning
nasal congestion, or any allergic reaction such as an itchy skin rash, swelling, breathing difficulties or wheezing
- hvis du er kvinde i den fødedygtige alder og ikke anvender sikker prævention
- women of childbearing potential unless using an effective method of contraception
- hvis du ammer
- if you are breast feeding
- hvis du har tyktarmsbetændelse (colitis ulcerosa) eller betændelse i mave- tarmkanalen
- if you have inflammation of the colon (ulcerative colitis) or intestinal tract (Crohn’ s disease)
(Crohns sygdom)
- if you have severe liver disease
- hvis du har meget dårlige nyrer
- if you have severe kidney disease
- hvis du har hjertesvigt, har fået diagnosticeret hjertesygdom og/ eller cerebrovaskulær sygdom,
- if you have heart failure, established heart disease and / or cerebrovascular disease, e. g. if you have
f. eks. hvis du har haft et hjertetilfælde, slagtilfælde, mini- slagtilfælde (TIA = transitorisk
had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain
45 iskæmisk attack, dvs. forbigående nedsat blodtilførsel til hjernen) eller tilstopning af blodårerne til hjertet eller hjernen
- if you have had an operation to clear or bypass blockages
- hvis du har fået foretaget en ballonudvidelse eller en by- passoperation
41
- eller hvis du har haft problemer med blodomløbet (perifer arteriel sygdom), eller hvis du har
- or if you have or have had problems with blood circulation (peripheral arterial disease) or if you
fået foretaget operation i årerne i benene
have had surgery on the arteries of your legs
Vær ekstra forsigtig med at tage Onsenal Nogle patienter har brug for særlig lægelig opmærksomhed, når de behandles med Onsenal.
Take special care with ONSENAL Some people will need special care from their doctors when they are taking Onsenal.
Tal med lægen, inden du tager Onsenal:
Make sure that your doctor knows before you start taking Onsenal:
- hvis du lider af sygdomme, som øger risikoen for hjertesygdom, f. eks. forhøjet blodtryk,
- if you have conditions which increase your risk of heart disease such as high blood pressure, diabetes,
Tal med lægen om, hvorvidt Onsenal er passende behandling for dig
high cholesterol or if you smoke you should discuss with your doctor whether Onsenal is suitable for you
- hvis du har haft mavesår eller sår i tolvfingertarmen (duodenalsår), eller blødning i maven
- if you have had a stomach or duodenal (intestinal) ulcer or bleeding in the stomach or intestines
Lægen ønsker muligvis at kontrollere
- if your heart, liver, or kidneys are not working well, your doctor may want to keep a regular check on
dig regelmæssigt.
you
- hvis du har væskeophobning i kroppen (som f. eks. hævede ankler eller fødder)
- if you have fluid retention (such as swollen ankles or feet)
- hvis du lider af væskemangel, f. eks. på grund af opkastning eller diarré, eller hvis du tager
- if you are dehydrated, for example by sickness or diarrhoea or if you are taking diuretic treatment
vanddrivende medicin
(water tablets)
- hvis du har haft en alvorlig allergisk reaktion eller en alvorlig hudreaktion efter at have taget
- if you have had a serious allergic reaction or a serious skin reaction to any medicines
- hvis du tager acetylsalicylsyre
- if you are taking acetylsalicylic acid
- hvis du tager blodfortyndende medicin
- if you are taking anticoagulants
- hvis du ikke tåler visse sukkerarter
- if you have intolerance to some sugars
- hvis du behandles for en infektion, da Onsenal kan skjule feber, som er tegn på infektion
- if you are being treated for an infection, because Onsenal may mask a fever which is a sign of an
Lægen ønsker muligvis at kontrollere dig regelmæssigt.
infection if you are over 65 years of age your doctor may want to keep a regular check on you
Lægen kan derfor ønske at kontrollere dit blodtryk regelmæssigt.
As with other non-steroidal, anti-inflammatory drugs (NSAIDs; eg, ibuprofen or diclofenac), this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
Dette gælder også medicin, som ikke er købt på recept.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
- ACE- hæmmere eller Angiotensin II- receptorantagonister (medicin mod højt blodtryk og
- ACE inhibitors or Angiotensin II receptor antagonists (used for high blood pressure and heart failure)
- acetylsalicylsyre eller anden medicin, der dæmper betændelse
- Acetylsalcylic acid or other anti-inflammatory medicines
- medicin, der nedsætter immunforsvaret f. eks. efter transplantationer (ciclosporin og tacrolimus)
- Cyclosporin and tacrolimus (used for immune system suppression e. g. after transplants)
- hostestillende medicin i hostesaft (dextromethorphan)
- Dextromethorphan (used as an antitussive in cough mixtures)
- vanddrivende medicin (medicin mod væskeophobning)
- Diuretics (used to treat fluid retention)
- medicin mod svampeinfektioner (fluconazol)
- Fluconazole (used to treat fungal infections)
- medicin mod depression (lithium)
- Lithium (used to treat depression)
- medicin mod bakterielle infektioner (rifampicin)
- Rifampicin (used to treat bacterial infections)
- medicin, som forhindrer blodpropper (warfarin) eller anden blodfortyndende medicin
- Warfarin (used to prevent blood from clotting) or other anticoagulants
- anden medicin mod depression, søvnforstyrrelser, forhøjet blodtryk eller uregelmæssig puls
- Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
- medicin mod visse psykiske lidelser (neuroleptika)
- Neuroleptics (used to treat some mental disorders)
- medicin mod leddegigt, alvorlig psoriasis og blodkræft (methotrexat)
- Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
- medicin mod epilepsi/ kramper eller visse typer smerter og depression (carbamazepin)
- Carbamazepine (used to treat epilepsy/ seizures and some forms of pain or depression)
- medicin mod epilepsi/ kramper eller visse typer søvnforstyrrelser (barbiturater)
- Barbiturates (used to treat epilepsy/ seizures and some sleep disorders)
46 Brug af Onsenal sammen med mad og drikke Du kan tage Onsenal sammen med mad eller uden for måltider.
Taking ONSENAL with food and drink You can take Onsenal with or without food.
Graviditet og amning Du må ikke tage Onsenal, hvis du er gravid, eller hvis der er mulighed for, at du bliver gravid.
Pregnancy and breast-feeding You must not take Onsenal if you are pregnant or if it is possible that you become pregnant.
Trafik - og arbejdssikkerhed Hvis du bliver svimmel eller træt efter at have taget Onsenal, bør du ikke køre bil eller betjene maskiner, før du føler dig normal igen.
42 Driving and using machines If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Hvis du har taget for mange Onsenal Kontakt straks læge eller apotek, hvis du ved et uheld kommer til at tage for mange kapsler.
If you take more ONSENAL than you should If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.
Hvis du har glemt at tage Onsenal Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
If you forget to take ONSENAL Do not take a double dose to make up for forgotten individual doses.
- hvis du får en allergisk reaktion, som f. eks. hudkløe, hævelse i ansigtet, hvæsende
Stop taking the capsules and tell your doctor immediately − If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing − If you have heart problems such as pain in the chest − If you have liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)) − If you have blistering or peeling of the skin − If you have severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood
vejrtrækning eller vejrtrækningsbesvær
Common side effects which may affect more than 1 person in 100, are listed below
- hvis du får hjerteproblemer, som f. eks. smerter i brystet
- Fluid build up with swollen ankles, legs and/ or hands
dine øjne bliver gult))
- Urinary infections
- hvis du får kraftige mavesmerter eller tegn på blødning i maven eller tarmene, som f. eks.
- Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore
forbigående sort eller blodig afføring, eller kaster blod op
throat, coughs, colds, flu-like symptoms
Almindelige bivirkninger, som forekommer hos mere end 1 person ud af 100, er
- Dizziness, difficulty sleeping
halsen, hoste, forkølelse, influenzalignende symptomer
- stomach ache, diarrhoea, indigestion, wind
- svimmelhed, søvnbesvær
- Rash, itching
- hududslæt, kløe
- Muscle stiffness
- muskelstivhed
43
- forværring af eksisterende allergi
- Worsening of existing allergies
- hjertesvigt, hjertebanken (bevidsthed om at hjertet slår), hurtig puls
- Heart failure, palpitations (awareness of heart beat), fast heart rate
- forværring af eksisterende forhøjet blodtryk
- Worsening of existing high blood pressure
- unormale lever- relaterede blodprøver
- Abnormalities in liver-related blood tests
- unormale nyre- relaterede blodprøver
- Abnormalities in kidney-related blood tests
- blodmangel (ændringer i de røde blodlegemer, som kan give træthed og kortåndethed)
- Anaemia (changes in red blood cells that can cause fatigue and breathlessness)
- angst, depression, træthed, døsighed, prikkende, snurrende fornemmelse eller følelsesløshed i
- Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)
- kvalme, træthed, muskelsvaghed eller hjertebanken pga. for højt indhold af kalium i blodet
- High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle
- nedsat eller sløret syn, susen for ørerne, mundsmerter eller mundsår
weakness or palpitations)
- forstoppelse, bøvsen, betændelse i maven (mavebesvær, mavesmerter eller opkastning),
- Impaired or blurred vision, ringing in the ears, mouth pain and soresConstipation, burping, stomach
forværring af betændelse i maven eller tarmen
inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine.
- kramper i benene
- Leg cramps
- kløende udslæt (nældefeber)
- Raised itchy rash (hives)
Sjældne bivirkninger, som forekommer hos mere end 1 person ud af 10. 000, er
Rare side effects which may affect more than 1 person in a 10,000, are listed below
- sår (blødende) i maven, spiserør eller tarm, hul på tarmen (kan give mavesmerter, feber,
- Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach
kvalme, opkastning, tilstopning af tarmen), mørk eller sort afføring, betændelse i spiserøret (kan give problemer med at synke), betændelse i bugspytkirtlen (kan give mavesmerter)
ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain)
- nedsat antal hvide blodlegemer (som hjælper med at beskytte kroppen mod infektioner) og
- Reduced number of white blood cells (which help protect the body from infection) and blood platelets
blodplader (øget risiko for blødning og blå mærker)
(increased chance of bleeding or bruising)
- problemer med at koordinere muskelbevægelser
- Difficulty coordinating muscular movements
- forvirring, ændret smagsopfattelse
- Feeling confused, changes in the way things taste
- øget følsomhed over for lys
- Increased sensitivity to light
- hårtab
- Loss of hair
Yderligere bivirkninger er set efter brug af det aktive stof i Onsenal (efter markedsføring).
Additional reactions have been reported from actual use of the active ingredient of Onsenal (in post- marketing experience).
Hyppigheden af disse bivirkninger er svær at bestemme, men anses generelt for at være meget sjældne (forekommer hos mindre end 1 person ud af 10. 000):
The frequencies of these reactions are difficult to determine but are generally considered to be very rare (affecting less than 1 person in every 10,000) − Bleeding within the brain causing death − Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing − Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon, nausea (feeling sick) − Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) − Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant).
Symptomerne kan være kvalme, diarré, gulsot, gulfarvning af hud eller det hvide i øjnene, mørk urin, lys afføring, blødningstendens, kløe eller kuldegysninger.
Symptoms may include nausea (feeling sick), diarrhoea, jaundice, yellow discolouration of the skin or eyes, dark urine, pale stools, bleeding easily, itching or chills Kidney problems (possible kidney failure, inflammation of the kidneys) − Irregular heartbeat − Meningitis (inflammation of the membrane around the brain and spinal cord) − Hallucinations − Worsening of epilepsy (possible more frequent and/ or severe seizures) − Inflamed blood vessels (can cause fever, aches, purple blotches on the skin) − Blockage of an artery or vein in the eye leading to partial or complete loss of vision, conjunctivitis, eye infection (pink eye), bleeding in the eye − A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections) − Impaired sense of smell − Skin discolouration (bruising), muscle pain and weakness, painful joints
- blokering af en arterie eller blodåre i øjet, som kan medføre delvist eller fuldstændigt tab af
44 − Menstrual disturbances − Headache, flushing − Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness)
Almindelige bivirkninger, som forekommer hos mere end 1 person ud af 100:
Very Common side-effects (affecting more than 1 person in every 10): − High blood pressure*, diarrhoea*
blive meget smertfuldt eller betændt, opkastning *, irritabel tyktarm (kan omfatte mavesmerter, diarré, fordøjelsesbesvær, luft i maven)
Common − Heart problems: heart attack*, angina (chest pain) − Stomach problems: nausea, heartburn, diverticulum (a problem with the stomach or intestine that can become painful or infected), vomiting*, irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind) − Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine, increased creatinine (blood test result related to kidney function) − Difficulty breathing − Muscle spasms − Oedema (water retention that can cause swelling) − Enlarged or inflamed prostate, prostate specific antigen increased (lab test) − Infections of various types − Weight gain
- nyresten (som kan give mave - eller rygsmerter, blod i urinen), vandladningsbesvær
Uncommon − Stroke − Unstable angina (chest pain), troubles with heart valves, rhythm, or coronary arteries, or enlarged heart − Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems), bruising − Stomach infection(which can cause irritation and ulcers of the stomach and intestines), bleeding from piles/ haemorrhoids, frequent bowel movements, inflamed or bleeding gums/ mouth sores − Lower limb fracture, tendon rupture or inflammation − Shingles, skin infection, allergic dermatitis (dry itchy rash) − Floaters or haemorrhage in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, difficulty speaking − Difficulty sleeping, excessive urination at night − Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot) − Α bnormal or heavy bleeding from the vagina, painful menstruation, breast pain, ovarian cyst, menopausal symptoms − High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test results − Decreased hearing − Changes in blood counts
- vejrtrækningsbesvær
HOW TO STORE ONSENAL