natgillin/translations-raw huggingface dataset:
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Nije poznato izlučuje li se Twinrix Paediatric u majčino mlijeko, no ne očekuju se problemi od cjepiva u dojene djece.
Re-suspension of the vaccine to obtain a uniform hazy white suspension
Resuspendiranje cjepiva kako bi se dobila jednolična mutna bijela suspenzija.
• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• smanjenje broja krvnih pločica, što povećava rizik od krvarenja ili pojave modrica
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Paediatric indiciran je za primjenu u neimune djece i adolescenata od 1. godine do uključivo 15. godine života koji su pod rizikom od zaraze i hepatitisom
Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Alternativno, u osoba koje su primarno cijepljene cjepivom Twinrix Paediatric, za docjepljivanje se može primijeniti jedno od monovalentnih cjepiva.
The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Učinak cjepiva Twinrix Paediatric na embrio-fetalno, perinatalno i postnatalno preživljenje i razvoj nije bilo prospektivno praćeno u kliničkim ispitivanjima.
In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects one month after the first dose and in 100% one month after the third dose (i.e. month 7).
A utvrđena su u približno 89% ispitanika mjesec dana nakon prve doze, te u 100% njih mjesec dana nakon treće doze (tj. mjesec 7).
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Način primjene Twinrix Paediatric daje se intramuskularnom injekcijom, poželjno u deltoidno područje adolescentima i većoj djeci ili u anterolateralni dio bedra maloj djeci.
0.025 milligrams Al3+ Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
0,025 miligrama Al3+ 3 proizveden tehnologijom rekombinantne DNK na stanicama kvasca (Saccharomyces cerevisiae) 4 adsorbiran na aluminijev fosfat
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens.
Istodobna primjena cjepiva Twinrix Paediatric s cjepivom Cervarix (HPV cjepivo) nije pokazala klinički značajnu interferenciju u imunološkom odgovoru na HPV i hepatitis A antigen.
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
• ljubičaste ili crvenkasto-ljubičaste izbočine na koži (lichen planus), ozbiljan kožni osip
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Drugi lijekovi i Twinrix Paediatric Twinrix Paediatric može se dati istovremeno s cjepivom protiv humanog papilomavirusa (HPV) na odvojenim mjestima aplikacije (drugi dio tijela, npr. druga ruka) tijekom iste posjete liječniku.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe febrile illness.
Primjenu cjepiva Twinrix Paediatric treba odgoditi u osoba oboljelih od teže akutne bolesti praćene vrućicom.
Influenza like illness*, chills*
rijetko bolest nalik gripi*, zimica*
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
oticanje očiju i lica, otežano disanje ili gutanje, nagli pad krvnog tlaka ili gubitak svijesti.
• Aching muscles
• bolovi u mišićima
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied.
Jedino je istovremena primjena cjepiva Twinrix Paediatric i cjepiva Cervarix posebno ispitivana.
The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Učinak cjepiva Twinrix Paediatric na embrio-fetalno, perinatalno i postnatalno preživljenje i razvoj procjenjivan je na štakorima.
Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Opći poremećaji i reakcije na mjestu primjene vrlo često bol i crvenilo na mjestu injiciranja često oticanje na mjestu injiciranja, reakcije na mjestu injiciranja (poput modrica), umor, malaksalost, vrućica (≥ 37,5°C)
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
A i/ili hepatitisa B, može se dati monovalentno ili kombinirano cjepivo.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Ipak, prilikom istovremene primjene monovalentnih cjepiva protiv hepatitisa A i hepatitisa B sa specifičnim imunoglobulinima, nije opažen utjecaj na serokonverziju,
Twinrix Paediatric contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Molimo recite svom liječniku ako ste ikad imali alergijsku reakciju na neomicin (antibiotik).
• Infection around the brain which may give severe headache with stiff neck and sensitivity to light
• oticanje zglobova, slabost mišića • upala moždanih ovojnica koja može uzrokovati tešku glavobolju s ukočenošću vrata i osjetljivošću na svjetlost (meningitis)
Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain
Poremećaji probavnog sustava često gastrointestinalni simptomi, mučnina manje često proljev, povraćanje, bol u abdomenu
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Titri anti-HBs i anti-HAV protutijela utvrđeni nakon primarnog ciklusa cijepljenja kombiniranim cjepivom u rasponu su titara utvrđenih nakon cijepljenja monovalentnim cjepivima.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFATURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
It is unknown whether Twinrix Paediatric is excreted in human breast milk.
Nije poznato izlučuje li se Twinrix Paediatric u majčino mlijeko u ljudi.
Uncommon Myalgia* Rare
rijetko artralgija*
It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Nije poznato hoće li u tom slučaju Twinrix Paediatric spriječiti obolijevanje od hepatitisa A,
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane često smanjen tek
Hepatitis A virus (inactivated)1,2
TVARI 1 doza (0,5 ml) sadrži: inaktivirani virus hepatitisa A 1,2
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Vrlo rijetke (mogu se javiti kod do 1 na 10 000 doza cjepiva):
Frequencies are reported as: Very common: ≥ 1/10 Common:
Učestalosti pojavljivanja definirane su kao: Vrlo često:
How to store Twinrix Paediatric
Kako čuvati Twinrix Paediatric
Posology - Dosage
Doziranje - Doza
years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
dok ih je 97% zadržalo anti-HBs protutijela ≥10 mIU/ml.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
A i protiv hepatitisa B može se dati Twinrix
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Nema podataka o istodobnoj primjeni cjepiva Twinrix Paediatric i specifičnih imunoglobulina protiv hepatitisa
Very rare: System Organ Class
Klasifikacija organskih sustava
The excretion of Twinrix Paediatric in milk has not been studied in animals.
Nije ispitivano izlučivanje cjepiva Twinrix Paediatric u mlijeko kod životinja.
Very common Pain and redness at the injection site Common
Opći poremećaji i reakcije na mjestu primjene trenutna bol na mjestu injiciranja
How Twinrix Paediatric is given
Kako se primjenjuje Twinrix Paediatric
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11
U 5 godina nakon uvođenja rasporeda cijepljenja od 0, 1, 6 mjeseci cjepivom Twinrix Paediatric kod djece u dobi od 1 do 11 godina, svi praćeni ispitanici zadržali su anti-HAV protutijela ≥15 mIU/ml,
• Generally feeling unwell, tiredness
• opće loše osjećanje, umor
Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Twinrix Paediatric - Suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv hepatitisa A (inaktiviranog) i hepatitisa B (rDNA) (HAB) (adsorbirano)
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Još nije u potpunosti utvrđeno treba li imunokompetentnim osobama koje su odgovorile na cijepljenje protiv hepatitisa
• Swollen glands in the neck armpit or groin (lymphadenopathy)
• oticanje limfnih čvorova na vratu, pod pazuhom ili u preponama (limfadenopatija)
The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
koje se javljaju s učestalošću po dozi od 28,5% odnosno 11,5%.
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Rijetke (mogu se javiti kod do 1 na 1000 doza cjepiva):
Package leaflet: Information for the user
Sadržaj pakiranja i druge informacije
It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
Ne preporučuje se Twinrix Paediatric primijeniti istodobno s drugim cjepivima, osim ako nije riječ o cjepivu Cervarix.
In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
godina kod djece starosti od 12 do 15 godina, te do 5 godina kod djece starosti od 1 do 11 godina.
12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
dok ih je 85% zadržalo anti-HBs protutijela ≥10 mIU/ml.
Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Što je Twinrix Paediatric i za što se koristi Twinrix Paediatric je cjepivo namijenjeno za primjenu u djece i adolescenata od navršene 1. godine života do uključivo 15. godine, u svrhu prevencije dviju bolesti: hepatitisa A i hepatitisa B.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Manje česte (mogu se javiti kod do 1 na 100 doza cjepiva):
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
KVALITATIVNI I KVANTITATIVNI SASTAV 1 doza (0,5 ml) sadrži: inaktivirani virus hepatitisa A 1,2
GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged
U 10 godina nakon uvođenja rasporeda cijepljenja od 0, 1, 6 mjeseci cjepivom Twinrix Paediatric kod djece u dobi od 12 do 15 godina, svi praćeni ispitanici zadržali su anti-HAV protutijela ≥15 mIU/ml,
Irritability
Nuspojave
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki + 20 igli 10 x 1 doza (0,5 ml)
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Praćenje nakon stavljanja cjepiva u promet Sljedeće su nuspojave prijavljene nakon primjene cjepiva Twinrix ili monovalentnih cjepiva protiv hepatitisa
NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Uputa o lijeku: Informacija za korisnika Twinrix Paediatric, suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv hepatitisa A (inaktiviranog) i hepatitisa B (rDNA) (HAB) (adsorbirano)
What you need to know before you receive Twinrix Paediatric
Što morate znati prije nego primite cjepivo Twinrix Paediatric Twinrix Paediatric se ne smije dati ako:
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki + 10 igli 10 x 1 doza (0,5 ml)
50 x 1 dose (0.5 ml)
50 napunjenih štrcaljki 50 x 1 doza (0,5 ml)
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.
Mogu se pojaviti sljedeće nuspojave: Nuspojave zabilježene tijekom kliničkih ispitivanja ili rutinske primjene ovog cjepiva ili zasebnih cjepiva protiv hepatitisa
Uncommon Upper respiratory tract infection*
Infekcije i infestacije manje često infekcija gornjih dišnih putova*
NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric, suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Cjepivo protiv hepatitisa A (inaktiviranog) i hepatitisa B (rDNA) (HAB) (adsorbirano).
10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki 10 x 1 doza (0,5 ml)
- neomycin.
• omaglica
Investigations
PRIMJENU
This summary was last updated in 02-2016.
Sažetak je posljednji put ažuriran: 02.2016.
The full EPAR for Zoledronic acid Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Zoledronatna kiselina Actavis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Actavis.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Zoledronatna kiselina Actavis.
This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
To znači da je lijek Zoledronatna kiselina Actavis sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Zometa.
It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Dostupan je kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
To uključuje frakture (lomove kosti), spinalnu kompresiju (kada kost pritišće leđnu moždinu), koštane poremećaje koji zahtijevaju radioterapiju (terapiju zračenjem) ili kirurški zahvat te hiperkalcemiju (visoke koncentracije kalcija u krvi).
In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Osim toga, tvrtka koja lijek Zoledronatna kiselina Actavis stavlja u promet bolesnicima će dati karticu s informacijama o riziku od osteonekroze čeljusti (oštećenje kosti čeljusti koje može uzrokovati bol, ranice u ustima ili klimanje zuba) i uputama o tome da se obrate svom liječniku ako primijete takve simptome.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
CHMP je zaključio da je u skladu sa zahtjevima EU-a dokazano da je Zoledronatna kiselina Actavis usporediva s lijekom Zometa.
The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Uobičajena doza lijeka Zoledronatna kiselina Actavis je jedna infuzija od 4 mg u trajanju od najmanje 15 minuta.
Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Zoledronatna kiselina Actavis generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
For more information about treatment with Zoledronic acid Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Zoledronatna kiselina Actavis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zoledronatna kiselina Actavis.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zoledronatna kiselina Actavis na snazi u Europskoj uniji od 20. travnja 2012.
By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.
Sprječavanjem loma kostiju Zoledronatna kiselina Actavis također pomaže u smanjenju količine kalcija koja se oslobađa u krv.
It is not recommended for patients with severe kidney problems.
Lijek nije preporučljiv za bolesnike koji imaju ozbiljne probleme s bubrezima.
Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Zoledronatnu kiselinu Actavis smije primjenjivati samo liječnik s iskustvom u uporabi ove vrste lijeka koji se daje u venu.
No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Nisu bila potrebna dodatna ispitivanja jer je Zoledronatna kiselina Actavis generički lijek koji se daje infuzijom i koji sadrži istu djelatnu tvar kao i referentni lijek Zometa.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Zoledronatna kiselina Actavis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.
Zoledronatna kiselina Actavis može se također koristiti za liječenje hiperkalcemije uzrokovane tumorima.
Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zoledronatna kiselina Actavis može se koristiti za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom koji zahvaća kosti.
Zoledronic acid Actavis is a ‘generic medicine'.
Zoledronatna kiselina Actavis je „generički lijek”.
A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zoledronatna kiselina Actavis.
The company provided data from the published literature on zoledronic acid.
Tvrtka je dostavila podatke o Zoledronatnoj kiselini iz objavljene literature.
What measures are being taken to ensure the safe and effective use of Zoledronic acid Actavis?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zoledronatna kiselina Actavis?
The Committee recommended that Zoledronic acid Actavis be given marketing authorisation.
Odbor je preporučio da se izda odobrenje za stavljanje u promet lijeka Zoledronatna kiselina Actavis.
The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Djelatna tvar u lijeku Zoledronatna kiselina Actavis, zoledronatna kiselina, je bisfosfonat.
Zoledronic acid Actavis zoledronic acid
Zoledronatna kiselina Actavis zoledronatna kiselina
Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg).
Zoledronatna kiselina Actavis lijek je koji sadrži zoledronatnu kiselinu (4 mg) kao djelatnu tvar.
Other information about Zoledronic acid Actavis
Ostale informacije o lijeku Zoledronatna kiselina Actavis
What are the benefits and risks of Zoledronic acid Actavis?
Koje su koristi i rizici od lijeka Zoledronatna kiselina Actavis?
Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Stoga je stav CHMP-a kako koristi nadmašuju utvrđeni rizik, kao i kod lijeka Zometa.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Ako se koristi za sprječavanje koštanih komplikacija, infuzija se može ponoviti svaka tri do četiri tjedna, a bolesnik treba također uzimati dopunske pripravke kalcija i vitamina D.
Why has Zoledronic acid Actavis been approved?
Zašto je lijek Zoledronatna kiselina Actavis odobren?
What is Zoledronic acid Actavis?
Što je Zoledronatna kiselina Actavis?
What is Zoledronic acid Actavis used for?
Za što se Zoledronatna kiselina Actavis koristi?
How is Zoledronic acid Actavis used?
Kako se koristi Zoledronatna kiselina Actavis?
How does Zoledronic acid Actavis work?
Kako djeluje Zoledronatna kiselina Actavis?
How has Zoledronic acid Actavis been studied?
Kako je lijek Zoledronatna kiselina Actavis ispitivan?
You may require a blood transfusion.
Možda će Vam trebati transfuzija krvi.
- Sudden death.
- Iznenadna smrt.
if you are pregnant.
- ako ste trudni.
Distribution into testes is relatively low.
Distribucija u testise je relativno mala.
Time to recovery
Vrijeme do oporavka
Do not give this medicine to children and adolescents from birth up to age of 18 years as safety and efficacy in children and adolescents have not been established.
Nemojte davati ovaj lijek djeci i adolescentima u dobi od rođenja do 18 godina jer sigurnost i djelotvornost u djece i adolescenata nije ustanovljena.
Plasma concentrations decrease rapidly during the first two hours and slowly thereafter.
Koncentracije u plazmi smanjuje se brzo tijekom prva dva sata, a nakon toga sporije.
In men, no data are available.
Za muškarce nema dostupnih podataka.
- Changes in weight.
- Promjene u težini.
There is little experience in children and adolescents.
Postoji malo iskustva u djece i adolescenata.
There are insufficient data that allows for dose adjustment recommendations.
Nema dovoljno podataka koji omogućuju preporuke za prilagodbu doze.
If this happens, the infusion must be stopped and restarted in another vein.
Ako se to dogodi, infuzija se mora zaustaviti i ponovo započeti u drugoj veni.