FrancophonIA/ELRC3.0 huggingface dataset:
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Icelandic: Bólgueyðandi gigtarlyf (þ.e. acetýlsalicýlsýra í bólgueyðandi skömmtum, COX-2 hemlar og ósértæk bólgueyðandi gigtarlyf) geta dregið úr blóðþrýstingslækkandi áhrifum angíótensín II blokka.
English: • if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
Icelandic: - ACE-hemil (til dæmis enalapríl, lisinopríl, ramipríl) sérstaklega ef þú ert með nýrnakvilla sem tengjast sykursýki.
English: Contains sorbitol (E420).
Icelandic: HJÁLPAREFNI Inniheldur sorbitol (E420) Sjá nánari upplýsingar í fylgiseðli.
English: Immune system disorders: Rare hypersensitivity, anaphylactic reaction
Icelandic: Ónæmiskerfi Sjaldgæfar ofnæmi, bráðaofnæmisviðbrögð
English: The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day.
Icelandic: Ráðlagður hámarksskammtur er ein tafla 80 mg telmisartan/10 mg amlodipin á sólarhring.
English: Uncommon somnolence, migraine, headache, paraesthesia
Icelandic: Sjaldgæfar svefnhöfgi, mígreni, höfuðverkur, húðskynstruflanir
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure ( 11.1/ 9.2 mmHg, 11.3/ 9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus 7.4/ 6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Icelandic: Eftir 8 vikna meðferð höfðu báðir styrkleikar samsetta lyfsins tölfræðilega marktæka yfirburði yfir amlodipin einlyfjameðferð í að lækka lagbils- og slagbilsþrýsting (-11,1/-9,2 mmHg, -11,3/ -9,3 mmHg með 40 mg/10 mg, 80 mg/10 mg á móti -7,4/-6,5 mmHg með 10 mg af amlodipini) og hærri tíðni blóðþrýstings í lagbili innan eðlilegra marka samanborið við einlyfjameðferð (63,7%, 66,5% með 40 mg/10 mg, 80 mg/10 mg á móti 51,1% með 10 mg af amlodipini).
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures ( 13.6/ 9.4 mmHg, 15.0/ 10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus 6.2/ 5.7 mmHg, 11.1/ 8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Icelandic: Eftir 8 vikna meðferð höfðu báðir styrkleikar samsetta lyfsins tölfræðilega marktæka yfirburði yfir báða styrkleika amlodipins einlyfjameðferðar í að lækka slagbils- og lagbilsþrýsting (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg með 40 mg/5 mg, 80 mg/5 mg á móti -6,2/-5,7 mmHg, -11,1/-8,0 mmHg með amlodipini 5 mg og 10 mg og hærri tíðni stjórnunar á blóðþrýstingi í lagbili samanborið við einlyfjameðferðirnar í hvoru tilviki fyrir sig (56,7%, 63,8% með 40 mg/5 mg og 80 mg/5 mg á móti 42%, 56,7% með amlodipini 5 mg og 10 mg).
English: The rate and extent of absorption of Twynsta are equivalent to the bioavailability of telmisartan and amlodipine when administered as individual tablets.
Icelandic: Lyfjahvörf lyfjasamsetningarinnar með staðlaðri skammtasamsetningu Hraði og umfang frásogs Twynsta samsvarar aðgengi telmisartans og amlodipins þegar þau eru gefin í töflum hvort í sínu lagi.
English: These pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Icelandic: Komið var í veg fyrir þessar lyfjamiðluðu aukaverkanir, sem þekktar eru úr forklínískum rannsóknum bæði á ACE-hemlum og angíótensín II viðtakahemlum, með gjöf saltvatns til drykkjar.
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene.
Icelandic: Hjá dýrum hefur banvænt sleglatif og hjartalost vegna blóðkalíumhækkunar komið fram eftir gjöf verapamils og gjöf dantrólens í bláæð.
English: Twynsta once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Icelandic: Twynsta einu sinni á sólarhring veitir virka og stöðuga lækkun á blóðþrýstingi á sólarhringsskammtabilinu.
English: In animal studies, reproductive toxicity was observed at high doses (see section 5.3).
Icelandic: Í dýrarannsóknum komu fram eiturverkanir á æxlun við gjöf á stórum skömmtum (sjá kafla 5.3).
English: Rare thrombocytopenia, eosinophilia
Icelandic: Mjög sjaldgæfar blóðflagnafæð, eosínfíklafjöld
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
Icelandic: Aukning á ákveðinni gerð af hvítum blóðkornum (eosínfíklafjöld), blóðflagnafæð, ofnæmiseinkenni (t.d. útbrot, kláði, öndunarörðugleikar, hvæsandi öndun, bólga í andliti eða lágþrýstingur), lágur blóðsykur (hjá sjúklingum með sykursýki), sjóntruflanir, hraður hjartsláttur, magaóþægindi, óeðlileg lifrarstarfsemi, ofsakláði, svæsin lyfjaútbrot, bólga í sinum, flensulík einkenni (t.d. vöðvaverkur, almenn vanlíðan), minnkun á blóðrauða (hemóglóbíni), aukning kreatínfosfókínasa í blóði.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun, increased muscle tension.
Icelandic: Hvítkornafæð, blóðflagnafæð, ofnæmiseinkenni (t.d. útbrot, kláði, öndunarörðugleikar, más, bólga í andliti eða lágþrýstingur), blóðsykurshækkun, óviðráðanlegar hreyfingar með rykkjum eða kippum, hjartaáfall, hjartsláttaróregla, æðabólga, brisbólga, magabólga, lifrarbólga, gula, hækkun lifrarensíma með gulu, ofsabjúgur (hröð bjúgmyndun í húð og slímhúð), alvarleg húðviðbrögð, ofsakláði, alvarleg ofnæmisviðbrögð með blöðrumyndun á húð og slímhúð (húðbólga með flögnun, Stevens-Johnson heilkenni), ljósnæmi, aukin vöðvaspenna.
English: Not known (frequency cannot be estimated from the available data): Severe allergic reactions with blistering eruptions of the skin and mucous membranes (toxic epidermal necrolysis).
Icelandic: Alvarleg ofnæmisviðbrögð með blöðrumyndun á húð og slímhúð (eitrunardreplos húðþekju (toxic epidermal necrolysis)).
English: In this respect data concerning diastolic blood pressure are inconsistent.
Icelandic: Gögn um blóðþrýsting í lagbili stangast á hvað þetta varðar.
English: INFORMATION IN BRAILLE Twynsta 80 mg/10 mg
Icelandic: MEÐ BLINDRALETRI Twynsta 80 mg/10 mg
English: In some patients treated by calcium channel blockers, reversible biochemical changes in the head of spermatozoa have been reported.
Icelandic: Tilkynnt hefur verið um afturkræfar lífefnafræðilegar breytingar á höfði sæðisfrumna hjá sumum sjúklingum sem hafa fengið kalsíumgangaloka.
English: Rare hepatic function abnormal, liver disorder
Icelandic: Hjarta Sjaldgæfar hægtaktur, hjartsláttarónot
English: INFORMATION IN BRAILLE Twynsta 40 mg/10 mg
Icelandic: MEÐ BLINDRALETRI Twynsta 40 mg/10 mg
English: INFORMATION IN BRAILLE Twynsta 80 mg/5 mg
Icelandic: MEÐ BLINDRALETRI Twynsta 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets
Icelandic: Twynsta 80 mg/5 mg töflur
English: INFORMATION IN BRAILLE Twynsta 40 mg/5 mg
Icelandic: MEÐ BLINDRALETRI Twynsta 40 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets
Icelandic: Twynsta 80 mg/10 mg töflur
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets
Icelandic: Twynsta 40 mg/10 mg töflur
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets
Icelandic: Twynsta 40 mg/5 mg töflur
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Icelandic: Lýsing á útliti Twynsta og pakkningastærðir Twynsta 80 mg/10 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A4 og merki fyrirtækisins á hvíta laginu.
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Icelandic: Lýsing á útliti Twynsta og pakkningastærðir Twynsta 40 mg/10 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A2 og merki fyrirtækisins á hvíta laginu.
English: Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg .
Icelandic: Twynsta 80 mg/5 mg er ætlað fullorðnum sjúklingum þegar ekki hefur náðst fullnægjandi stjórn á blóðþrýstingi með Twynsta 40 mg/5 mg.
English: Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone.
Icelandic: Twynsta 40 mg/10 mg er ætlað fullorðnum sjúklingum þegar ekki hefur náðst fullnægjandi stjórn á blóðþrýstingi með amlodipini 10 mg einu og sér.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Twynsta 40 mg/10 mg tafla telmisartan/amlodipin
English: Renal and urinary disorders Uncommon renal impairment including acute renal failure micturition disorder, pollakiuria
Icelandic: Lifur og gall Mjög sjaldgæfar óeðlileg lifrarstarfsemi, lifrarkvilli
English: Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Icelandic: Twynsta 40 mg/5 mg er ætlað fullorðnum sjúklingum þegar ekki hefur náðst fullnægjandi stjórn á blóðþrýstingi með amlodipini 5 mg einu og sér.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: Hver tafla inniheldur 40 mg af telmisartani og 5 mg af amlodipini (sem amlodipin besilat).
English: • Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Icelandic: Telmisartan tilheyrir flokki lyfja sem kallast angíótensín II viðtakablokkar.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Twynsta 40 mg/5 mg tafla telmisartan/amlodipin
English: Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
Icelandic: Þar sem engar upplýsingar liggja fyrir um notkun telmisartans meðan á brjóstagjöf stendur er ekki mælt með notkun telmisartans/amlodipins.
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure.
Icelandic: Tilhneiging til fylgni milli skammta og þess tíma sem tekur að ná upphafsgildum blóðþrýstings í slagbili er greinileg.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Twynsta 80 mg/10 mg tafla telmisartan/amlodipin
English: Twynsta is not recommended for use in patients with hereditary fructose intolerance (HFI).
Icelandic: Ekki er mælt með að sjúklingar með arfgengt frúktósaóþol noti Twynsta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 40 mg telmisartan og 5 mg amlodiopin (sem amlodipin besilat)
English: With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.
Icelandic: eftir gjöf á 10 mg af amlodipini dregur úr frásogshraða amlodipins.
English: Very rare hyperglycaemia
Icelandic: Mjög sjaldgæfar lasleiki inflúensulík veikindi
English: Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Icelandic: Twynsta 40 mg/5 mg má gefa sjúklingum þegar ekki næst fullnægjandi stjórnun á blóðþrýstingi með amlodipini 5 mg einu og sér.
English: Twynsta 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg.
Icelandic: Twynsta 80 mg/5 mg má gefa sjúklingum þegar ekki næst fullnægjandi stjórnun á blóðþrýstingi með Twynsta 40 mg/5 mg.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Twynsta 80 mg/5 mg tafla telmisartan/amlodipin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 40 mg telmisartan og 10 mg amlodiopin (sem amlodipin besilat)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
Icelandic: PAKKAÐ SAMAN - MEÐ BLUE BOX - 40 mg/10 mg
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Icelandic: Hver tafla inniheldur 40 mg af telmisartani og 10 mg af amlodipini (sem amlodipin besilat).
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Icelandic: EU/1/10/648/001 (14 töflur) EU/1/10/648/002 (28 töflur) EU/1/10/648/003 (30 x 1 tafla) EU/1/10/648/004 (56 töflur) EU/1/10/648/005 (90 x 1 tafla) EU/1/10/648/006 (98 töflur)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/10/648/007 (360 (4 x 90 x 1) töflur)
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Icelandic: EU/1/10/648/001 (14 töflur) EU/1/10/648/002 (28 töflur) EU/1/10/648/003 (30 x 1 tafla) EU/1/10/648/004 (56 töflur) EU/1/10/648/005 (90 x 1 tafla) EU/1/10/648/006 (98 töflur) EU/1/10/648/007 (360 (4 x 90 x 1) töflur)
English: Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Icelandic: (The Veterans Affairs Nephropathy in Diabetes)) var samsett meðferð með ACE-hemli og angíótensín II viðtakablokka rannsökuð.
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Icelandic: Twynsta 40 mg/10 mg má gefa sjúklingum þegar ekki næst fullnægjandi stjórnun á blóðþrýstingi með amlodipini 10 mg einu og sér.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 80 mg telmisartan og 5 mg amlodiopin (sem amlodipin besilat)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/5 mg
Icelandic: PAKKAÐ SAMAN - MEÐ BLUE BOX - 40 mg/5 mg
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: Hver tafla inniheldur 80 mg af telmisartani og 5 mg af amlodipini (sem amlodipin besilat).
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Icelandic: Bláar og hvítar sporöskjulaga tveggja laga töflur með áþrykktu vörunúmerinu A1 og merki fyrirtækisins á hvíta laginu.
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Icelandic: EU/1/10/648/015 (14 töflur) EU/1/10/648/016 (28 töflur) EU/1/10/648/017 (30 x 1 tafla) EU/1/10/648/018 (56 töflur) EU/1/10/648/019 (90 x 1 tafla) EU/1/10/648/020 (98 töflur)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Icelandic: EU/1/10/648/015 (14 töflur) EU/1/10/648/016 (28 töflur) EU/1/10/648/017 (30 x 1 tafla) EU/1/10/648/018 (56 töflur) EU/1/10/648/019 (90 x 1 tafla) EU/1/10/648/020 (98 töflur) EU/1/10/648/021 (360 (4 x 90 x 1) töflur)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 80 mg telmisartan og 10 mg amlodiopin (sem amlodipin besilat)
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Icelandic: Hver tafla inniheldur 80 mg af telmisartani og 10 mg af amlodipini (sem amlodipin besilat).
English: Very rare vasculitis
Icelandic: Mjög sjaldgæfar sjóntruflanir
English: Twynsta contains sodium
Icelandic: Twynsta inniheldur sorbitól
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Icelandic: Bláar og hvítar sporöskjulaga tveggja laga töflur með áþrykktu vörunúmerinu A4 og merki fyrirtækisins á hvíta laginu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/10/648/014 (360 (4 x 90 x 1) töflur)
English: Rare syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Icelandic: Mjög sjaldgæfar yfirlið, úttaugakvilli, skert húðskyn, bragðskynstruflanir, skjálfti
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Icelandic: Bláar og hvítar sporöskjulaga tveggja laga töflur með áþrykktu vörunúmerinu A3 og merki fyrirtækisins á hvíta laginu.
English: Hepatic impairment
Icelandic: Sjaldgæfar geðsveiflur
English: Very rare side effect (may affect up to 1 in 10,000 people):
Icelandic: Aukaverkanir sem koma örsjaldan fyrir (geta komið fyrir hjá allt að 1 af hverjum 10.000 notendum):
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Icelandic: EU/1/10/648/022 (14 töflur) EU/1/10/648/023 (28 töflur) EU/1/10/648/024 (30 x 1 tafla) EU/1/10/648/025 (56 töflur) EU/1/10/648/026 (90 x 1 tafla) EU/1/10/648/027 (98 töflur)
English: USE OF THE MEDICINAL PRODUCT
Icelandic: NOTKUN LYFSINS
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/10/648/021 (360 (4 x 90 x 1) töflur)
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Icelandic: Twynsta 80 mg/5 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A3 og merki fyrirtækisins á hvíta laginu.
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Icelandic: EU/1/10/648/008 (14 töflur) EU/1/10/648/009 (28 töflur) EU/1/10/648/010 (30 x 1 tafla) EU/1/10/648/011 (56 töflur) EU/1/10/648/012 (90 x 1 tafla) EU/1/10/648/013 (98 töflur) EU/1/10/648/014 (360 (4 x 90 x 1) töflur)
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Icelandic: Twynsta 40 mg/5 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A1 og merki fyrirtækisins á hvíta laginu.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Icelandic: EU/1/10/648/022 (14 töflur) EU/1/10/648/023 (28 töflur) EU/1/10/648/024 (30 x 1 tafla) EU/1/10/648/025 (56 töflur) EU/1/10/648/026 (90 x 1 tafla) EU/1/10/648/027 (98 töflur) EU/1/10/648/028 (360 (4 x 90 x 1) töflur)
English: Add on therapy
Icelandic: B. FYLGISEÐILL
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/10/648/028 (360 (4 x 90 x 1) töflur)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Icelandic: EU/1/10/648/008 (14 töflur) EU/1/10/648/009 (28 töflur) EU/1/10/648/010 (30 x 1 tafla) EU/1/10/648/011 (56 töflur) EU/1/10/648/012 (90 x 1 tafla) EU/1/10/648/013 (98 töflur)
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Icelandic: Bláar og hvítar sporöskjulaga tveggja laga töflur með áþrykktu vörunúmerinu A2 og merki fyrirtækisins á hvíta laginu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Icelandic: Leiðrétta skal vökva- og/eða natríumskort áður en telmisartan er gefið.
English: tendon pain (tendinitis like symptoms)
Icelandic: Bólgueyðandi gigtarlyf (NSAID)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Icelandic: YTRI UMBÚÐUM YTRI MERKIMIÐI Á FJÖLPAKKNINGU MEÐ 360 (4 PAKKNINGAR
English: Impairment of fertility
Icelandic: Rottendorf Pharma
English: Rare vomiting, gingival hypertrophy, dyspepsia, dry mouth stomach discomfort
Icelandic: Mjög sjaldgæfar uppköst, ofvöxtur í tannholdi, meltingartruflanir, munnþurrkur magaóþægindi
English: Pharmacokinetic of the fixed dose combination
Icelandic: Milliverkanir sem tengjast þessari lyfjasamsetningu
English: What you need to know before you take Twynsta
Icelandic: Áður en byrjað er að nota Twynsta
English: Date of first authorisation: 06/11/2017.
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 06/11/2017.
English: ère avenue 2065 m LID 06516 Carros France
Icelandic: ère avenue 2065 m LID 06516
English: Protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Icelandic: Vörn gegn þrálátri veirublóðsýkingu kemur fram hjá 73% katta þremur vikum eftir fyrstu bólusetningu þeirra.
English: Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Icelandic: Ekki má blanda þessu dýralyfi við nein önnur dýralyf nema FELIGEN RCP eða FELIGEN CRP.
English: Box of 10 or 50 vials
Icelandic: ASKJA SEM Í ERU 10 EÐA 50 HETTUGLÖS.