natgillin/translations-raw huggingface dataset:
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Opis odabranih nuspojava kod karcinoma dojke za Taxespira 100 mg/m 2 u monoterapiji
Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Poremećaji živčanog sustava disgeuzija (G3/4: <1%); parestezija (G3/4: <1%)
Median OS (months) (95% CI)
MedijanTTP (mjeseci) (95% CI)
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 2370 mg bezvodnog etanola po 6 ml bočice, što odgovara 60 ml piva ili 25 ml vina.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m administered as a 30-minute to
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Za indukcijsko liječenje bolesnika s lokalno uznapredovalim (tehnički neresektabilnim, male vjerojatnosti kirurške izlječivosti, a s ciljem očuvanja organa) karcinomom skvamoznih stanica glave i vrata (engl.
EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
EU/1/15/1017/001 20 mg/1 ml bočica x 1 bočica
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
U ispitivanju GEICAM 9805 alopecija koja je počela tijekom perioda liječenja i dalje bila prisutna tijekom perioda praćenja zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
120mg/6 ml One vial of 6 ml concentration contains 120 mg docetaxel.
120 mg/ 6 ml Jedna bočica od 6 ml koncentrata sadrži 120 mg docetaksela.
• oral candidiasis (thrush)
• oralna kandidijaza
Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Opis odabranih nuspojava za Taxespira 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
General disorders and administration site conditions In study TAX316, peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
U ispitivanju TAX 316 periferni edem, koji se pojavio tijekom perioda liječenja te bio prisutan u periodu praćenja nakon završetka kemoterapije, zabilježen je u 119 od 744 bolesnika (16,0%) u TAC skupini i 23 od 736 bolesnika (3,1%) u FAC skupini.
Gastrointestinal haemorrhage (G3/4:
Poremećaji oka konjunktivitis (G3/4:
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
This regimen is administered every 3 weeks for 4 cycles.
Liječenje se ponavlja svaka 3 tjedna kroz 4 ciklusa.
120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
120 mg/6 ml Jedna bočica sa 6 ml koncentrata sadrži 120 mg docetaksela.
Single use vials.
Bočice za jednokratnu primjenu.
Arrhythmia (no severe)
Srčani poremećaji aritmija (ne teška)
Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva Poremećaji reproduktivnog sustava i dojki
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Tablični popis nuspojava kod karcinoma dojke za Taxespira 100 mg/m² u monoterapiji
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
EU/1/15/1017/002 80 mg/4 ml bočica x 1 bočica
Outer Carton
Vanjska kutija
General disorders and administration site conditions Investigations
Opći poremećaji i reakcije na mjestu primjene
Pfizer Kft. Tel: + 36 1 488 37 00
Tel: + 36 1 488 37 00
Rash pruritic; Dry skin; Skin exfoliative (G3/4:
Poremećaji kože i potkožnog tkiva eksfolijativni osip (G3/4:
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
Tablični popis nuspojava kod karcinoma dojke za Taxespira 75 mg/m² u kombinaciji s kapecitabinom
Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Taxespira 75 mg/m² u monoterapiji
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%); disgeuzija (G3/4: 0%)
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%)
51,5%); anemija (G3/4: 6,9%); trombocitopenija (G4:
Pfizer Corporation Austria Ges.m.b.H.
Hospira Enterprises B.V.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin
(1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m 2 primijenjen jedan sat nakon doksorubicina 50 mg/m 2 i ciklofosfamida 500 mg/m 2 (TAC skupina) ili doksorubicin
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
U bolesnika koje primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke, treba razmotriti primarnu profilaksu s G-CSF.
Tumour response rate (%) 95% CI p-value*
Broj bolesnika Stopa smanjenja boli (%) 95% CI p-vrijednost*
Fluid retention (severe/life-threatening: 1%)
retencija tekućine (teška/opasna
Lacrimation increased (G3/4:
Poremećaji oka pojačano suzenje (G3/4:
• For the treatment of lung cancer, Taxespira could be administered either alone or in
• Za liječenje karcinoma pluća Taxespira se primjenjuje sam ili u kombinaciji s cisplatinom.
Best overall response to chemotherapy (%)
Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
Infections (G3/4: 5%)
trombocitopenija (G3/4: 3%)
This regimen is administered every 3 weeks for 3 cycles.
Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
Lymphoedema (G3/4:
dermatitis eritematozni osip (G 3/4:
Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
Adjusted hazard ratio (95% CI) *p-value
Prilagođeni omjer hazarda (95% CI) *p-vrijednost
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tablični popis nuspojava za Taxespira 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Hazard ratio: (95% CI) **p-value
Omjer hazarda: (95% CI) **p-vrijednost
Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
proljev (G3/4: 3,4%); konstipacija (G3/4:
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 nakon čega je slijedio cisplatin (P) 75 mg/m 2 te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Za liječenje docetakselom u monoterapiji (100 mg/m u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256 bolesnika.
Peripheral sensory neuropathy Peripheral motor neuropathy
Poremećaji živčanog sustava periferna senzorna neuropatija (G 3:
Pfizer GEP, S.L.
Pfizer AB
Alopecia (persisting: <3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa (G3/4: 0%); dispneja (G3/4: 0,6%); kašalj (G3/4: 0%)
Venous disorder (G3/4:
Poremećaji probavnog sustava dispepsija (G3/4:
• If you get any side effects talk to your doctor, hospital pharmacist or nurse.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, bolničkog ljekarnika ili medicinsku sestru.
Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tablični popis nuspojava za Taxespira 75 mg/m 2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Poremećaji probavnog sustava mučnina (G 3/4: 2,4%); proljev (G 3/4: 1,2%); stomatitis/faringitis (G3/4:
Disease free survival
Preživljenje bez znakova bolesti
Taxespira 20 mg/1 ml concentrate for solution for infusion.
Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel i.v.
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija (G3/4: 0,3%) mialgija (G3/4: 0,3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Pri primjeni docetaksela u kombinaciji s drugim citostaticima i/ili radioterapijom, zabilježeni su slučajevi akutne mijeloične leukemije i mijelodisplastičnog sindroma.
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
dispneja (G3/4: 1%); kašalj (G3/4: <1%); epistaksa (G3/4: <1%)
Hypersensitivity (G3/4:
Poremećaji imunološkog sustava preosjetljivost (G3/4:
1,000 mg/m2 per day for 5 days.
• Docetaksel 75 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
Tel: +34 91 490 99 00
Pfizer GEP, S.L. Tel: +34 91 490 99 00
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m intravenskom. infuzijom na 1. dan nakon čega je slijedio cisplatin (P)
7.8%); Diarrhoea (G3/4: 6.2%);
Infekcije i infestacije infekcija (G3/4: 6,3%);
Psychiatric disorders Nervous system disorders
Poremećaji živčanog sustava disgeuzija/parosmija; periferna senzorna omaglica
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Poremećaji krvi i limfnog sustava neutropenija (G3/4: 63%); anemija (G3/4: 10%)
Taxespira as single agent
Pfizer AS
Oral candidiasis (G3/4:
Infekcije i infestacije oralna kandidijaza (G3/4:
Nausea (G3/4: 9.6%); Vomiting (G3/4:
Poremećaji probavnog sustava mučnina (G 3/4: 0,6%); stomatitis (G3/4:
0.8%); Gastrointestinal pain (G3/4: 1.2%);
gastrointestinalna bol (G3/4: 1,2%); gastrointestinalno krvarenje (G3/4:
Exfoliative rash (G3/4: 0.3%)
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
Mechanism unknown.
Mehanizam je nepoznat.
This can sometimes lead to serious medical conditions.
To ponekad može dovesti do ozbiljnih medicinskih stanja.
(Study conducted in 8 patients)
(Ispitivanje provedeno na 8 bolesnika)
(Possible mechanism)
(mogući mehanizam)
In this case close monitoring is required.
U tom slučaju potrebno je pozorno praćenje.
Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Ponavljajte korake 4 do 8 na isti način sve dok ne uzmete cijelu dozu lijeka.
For this reason, it is very important to talk to your doctor about any changes in your health.
Iz tog razloga, jako je važno da razgovarate sa svojim liječnikom o svim promjenama Vašeg zdravstvenog stanja.
APV exposure was 25-35% lower during pregnancy.
Izloženost APV-u bila je 25-35% manja tijekom trudnoće.
GSS was derived using ANRS 2007 guidelines.
GSS je dobiven koristeći ANRS 2007 smjernice.
Do not leave the syringe in the bottle.
Štrcaljku nemojte ostavljati u boci.
The reason for this is not known.
Nije poznat razlog zašto se to događa.
Swallow the tablets whole, with some water or another drink.
Tablete progutajte cijele, s malo vode ili drugog pića.
Date of renewal of authorisation: 15 May 2009.
Datum obnove odobrenja: 15. svibnja 2009.
• if they drink alcohol
• koji piju alkohol
These ingredients may cause allergic reactions (sometimes delayed).
Taj sastojak može izazvati alergijske reakcije (ponekad odgođene).
Data from this small number further analysed by GSS subgroups need to be interpreted with caution.
Podatke dobivene iz tog malog broja koji su dalje analizirani pomoću GSS podskupina treba interpretirati s oprezom.
To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.
Kako bi to izbjegli i spriječili pogoršanje Vaše bolesti, jako je važno da sve svoje lijekove uzimate točno onako kako su Vam propisani.
→ Don't drive or operate machinery unless you're feeling well.
Nemojte upravljati vozilima ili strojevima ako se ne osjećate dobro.
Do not take Telzir:
Nemojte uzimati Telzir:
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipično, takve se reakcije obično zamjećuju unutar prvih nekoliko tjedana ili mjeseci od početka primjene CART-a.
All Patients, RD=F Analysis2
Svi bolesnici, RD=F analiza2
• If you are taking any other medicines.
• Uzimate li neke druge lijekove.
Throw away the bottle 28 days after first opening it, but do not throw away any medicines via wastewater or household waste.
Bacite bočicu 28 dana nakon prvog otvaranja, ali nemojte nikada nikakve lijekove bacati u otpadne vode ili kućni otpad.
Therefore, no recommendations can be made in this patient population.
Stoga ne postoje preporuke za ovu populaciju bolesnika.
Adult years)
Odrasli godina)
However, the number of abortions increased.
Međutim, došlo je do povećanja broja pobačaja.
Protect other people.
Zaštitite druge osobe.
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Španjolska
GSS to OBT1
GSS do OBT1 0
If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before.
Ako zaboravite uzeti Telzir, uzmite ga čim se sjetite i zatim nastavite Vaše liječenje kao i ranije.
People may be more likely to get this condition:
Ljudi kod kojih je vjerojatnije da će razviti to stanje:
Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Telzir se tijekom trudnoće može primijeniti samo ako potencijalna korist opravdava potencijalni rizik za fetus.
You may still develop other infections and illnesses linked to HIV infection.
I dalje se kod Vas mogu pojaviti druge infekcije i bolesti povezane s HIV infekcijom
• Skin rashes (red, raised or itchy) - if the skin rash is severe, you may have to stop taking this medicine
• kožni osipi (crveni, izdignuti ili koji svrbe) - ako je kožni osip težak, možda ćete morati prestati uzimati ovaj lijek.
• fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
• flutikazon propionat i slični lijekovi koji se koriste za liječenje astme, osim ukoliko ih se smatra esencijalnima.
• warfarin and other medicines that stop blood clotting
• varfarin i drugi lijekovi koji sprječavaju zgrušavanje krvi
Don't push too hard and squirt the liquid into the back of the throat or you may choke.
Nemojte prejako pritisnuti i istisnuti tekućinu u stražnji dio grla jer bi se mogli ugušiti.
• Change in your body shape
• Promjenu izgleda Vašeg tijela
Three of 14 isolates had protease resistance mutations.
3 od 14 izolata imalo je mutacije rezistencije na proteaze.
Tell your doctor or pharmacist if you're taking or have recently taken any other medicinesthese include herbal medicines or other medicines you bought without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući biljne lijekove i one koje ste nabavili bez recepta.
Your doctor will work out the right dose based on your weight.
Liječnik će odrediti ispravnu dozu prema vašoj težini.
Elderly (over 65 years of age)
Stariji (iznad 65. godine života)
• methadone (a heroin substitute)
• metadon (zamjena za heroin)
Children less than 6 years of age
Djeca mlađa od 6 godina
If you are pregnant, think you may be pregnant, or are planning to have a baby: →Ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete: →Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Otkrivena je uzročnoposljedična veza iako mehanizam djelovanja nije razjašnjen.
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
What Telzir is and what it is used for
Što je Telzir i za što se koristi
(Read the package leaflet of Telzir oral suspension for guidance on whether to take it with or without food.)
(Pročitajte uputu o lijeku koja dolazi s Telzir oralnom suspenzijom za smjernice o tome trebate li ga uzimati sa ili bez hrane.)
Take the syringe and the adapter off and wash them thoroughly in clean water.
Skinite štrcaljku i nastavak te ih temeljito operite čistom vodom.
Discard 28 days after first opening.
Baciti 28 dana nakon prvog otvaranja.
Overall the safety profile in these 158 children and adolescents was similar to that observed in the adult population.
Ukupni sigurnosni profil kod tih 158 ispitanika dječje i adolescentske dobi bio je sličan onome za odraslu populaciju.
What you need to know before you take Telzir
Što morate znati prije nego počnete uzimati Telzir
This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines.
To je jako važno budući da Telzir ili ritonavir mogu pojačati ili oslabiti djelovanje drugih lijekova.
The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Primjena viših doza ritonavira mogla bi promijeniti sigurnosni profil kombinacije te se stoga ne preporučuje.
79 % of subjects received greater than 48 weeks of exposure.
Kod 79 % ispitanika izloženost je bila veća od 48 tjedana.
Use with caution.
Primijeniti uz mjere opreza.
It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor.
Jako je važno da uzmete punu dnevnu dozu lijeka Telzir i ritonavira kako Vam je propisao liječnik.
However you can still continue to take Telzir.
Međutim, i dalje možete nastaviti uzimati Telzir.
These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Ti simptomi su vjerojatno uzrokovani jačanjem imunološkog sustava kako bi tijelo započelo borbu s tim infekcijama.
Children less than 6 years of age Telzir is not recommended for children less than 6 years old.
Djeca mlađa od 6 godina Telzir se ne preporučuje za primjenu kod djece mlađe od 6 godina.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Trebalo bi razmotriti prilagodbu doze midazolama, pogotovo ako se primjenjuje više od jedne doze midazolama.
If this happens, Telzir must be stopped immediately and you must never take it again.
U tom slučaju morate odmah prestati uzimati Telzir i više nikada ga ne smijete ponovno uzeti.
The thyroid tumorigenic potential is regarded to be species-specific.
Tumorogeni potencijal za štitnjaču smatrao se specifičnim za vrstu.
Pull out the syringe plunger until the first portion of your full dose is withdrawn.
Izvlačite klip štrcaljke sve dok ne navučete prvi dio svoje pune doze.
EXP Discard 28 days after first opening
EXP Baciti 28 dana nakon prvog otvaranja.
The clinical relevance of these findings is unknown.
Nije poznat klinički značaj tih nalaza.
Women who are HIV-positive must not breast-feed because HIV infection can be passed on to the baby in breast milk.
Žene koje su HIV-pozitivne ne smiju dojiti zbog toga što se HIV infekcija može prenijeti na bebu putem majčina mlijeka.
Vomiting occurred more frequently amongst paediatric patients.
Povraćanje je bilo češće u pedijatrijskih bolesnika.
A 75 % reduction of the standard rifabutin dose (i.e. to 150 mg every other day) is recommended.
Preporučuje se 75 % smanjenje standardne doze rifabutina (tj. na 150 mg svaki drugi dan).
Paediatric / other populations
Pedijatrijska/ostale populacije
It is not known whether the ingredients in Telzir can also pass into your breast milk.
Nije poznato mogu li sastojci lijeka Telzir također prijeći u majčino mlijeko.
→ Use an alternative non-hormonal type of contraception such as a condom.
→Koristite alternativne, nehormonske metode kontracepcije, poput kondoma.
Like all medicines, this medicine can cause side effects, but not everyone gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
• Swelling of the face, lips and tongue (angioedema).
• oticanje lica, usana i jezika (angioedem).
2RD=F: Rebound or discontinuation equal failure analysis which is equivalent to TLOVR.
2RD=F: Analiza povratak ili prekid jednak neuspjehu ekvivalentna je TLOVR.