natgillin/translations-raw huggingface dataset:
Caution is advised when Zoledronic Acid Teva is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Pri uporabi zdravila Zoledronska kislina Teva skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Ne mešajte rekonstituirane raztopine zdravila Zoledronska kislina Teva z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
- Low level of magnesium and potassium in the blood.
- nizka koncentracija levkocitov in trombocitov, - nizki koncentraciji magnezija in kalija v krvi.
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
1,3 % (pri 51 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 0,6 % (pri 22 od
Dyspnoea, cough, bronchoconstriction
dispneja, kašelj, bronhokonstrikcija intersticijska bolezen pljuč
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Ob uporabi zoledronske kisline v zelo redkih primerih prišlo do dremavosti in zaspanosti.
− As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
− zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
To zdravilo ne smete mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Prišlo je do poudarjenega farmakološkega delovanja, domnevno zaradi zaviranja presnove kalcija v kosteh, ki je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celotno skupino difosfonatov), distocijo in predčasno prekinitev študije.
It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji),
Zoledronic Acid Teva concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Koncentrat zdravila Zoledronska kislina Teva se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in ga je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Poročali so o razvoju aritmij in nevroloških neželenih učinkov (vključno s konvulzijami, hipestezijo in tetanijo), do katerih je prišlo zaradi hude hipokalciemije.
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
zvišana telesna temperatura, gripi podoben sindrom (z utrujenostjo, okorelostjo, občutkom slabosti in napadi rdečice)
Patients should be adequately supplemented with calcium and vitamin D.
Bolniki morajo prejemati zadostno količino kalcija in vitamina D. Pomožne snovi
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
NA ne velja za ta primer Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate)
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
NA ne velja za ta primer Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline na razmerje pogostnosti z okostjem povezanih dogodkov (SRE),
In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic Acid Teva is used in combination with thalidomide.
Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zdravilo
The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12,0 mg/dl ali
- 4.1 ml for 3.3 mg dose
4,4 ml za odmerek 3,5 mg 4,1 ml za odmerek 3,3 mg 3,8 ml za odmerek 3,0 mg
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Bolnike s serumskim kreatininom > 400 μmol/l ali > 4,5 mg/dl so izključili iz kliničnih študij.
Patients must be assessed prior to administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Pred uporabo zdravila Zoledronska kislina Teva moramo bolnike pregledati, da zagotovimo, da so ustrezno hidrirani.
Zoledronic Acid Teva recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline
Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Pri doječih materah je uporaba zdravila Zoledronska kislina Teva kontraindicirana (glejte poglavje 4.3).
6.6 Special precautions for disposal and other handling Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Pred uporabo je treba 5,0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (9 mg/ml (0,9-odstotna) raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SREs) v skupini, ki je prejemala zoledronsko kislino 4 mg,
5 ml
4 mg/5 ml
How Zoledronic Acid Teva is given
Kako se zdravilo Zoledronska kislina Teva daje
Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
mravljinčenje ali odrevenelost rok ali stopal, driska, zaprtje bolečine v trebuhu, suha usta,
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Teva and inform your doctor about your dental treatment.
da prejemate zdravilo Zoledronska kislina Teva in obvestite svojega zdravnika o zdravljenju zob.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zoledronic Acid Teva dose is recommended (see also section 4.4):
(opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji odmerek zdravila Zoledronska kislina Teva (glejte tudi poglavje 4.4):
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
pamidronat 90 mg (N=99)
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
(neželeni učinek skupine difosfonatov) in osteonekroza na drugih anatomskih lokacijah, vključno s stegnenico in kolkom
Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
hipertenzija, hipotenzija, atrijska fibrilacija,
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Če ste noseči ali če dojite, se posvetujte z zdravnikom, preden vzamete katero koli zdravilo.
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilni koncentrat) bistra in brezbarvna raztopina
- Weight increase.
0,1 % maksimalne koncentracije.
METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
IME ZDRAVILA IN POT(I) UPORABE
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
- bolečina v prsih, - kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, - visok krvni tlak, zadihanost, omotičnost, tesnoba, motnje spanja, motnja okušanja, tresenje,
Interstitial lung disease
Atipičen zlom stegnenice
If you get any side effects, talk to your doctor pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Teva.
Pri bolnikih, ki so se zdravili z zdravilom Zoledronska kislina Teva, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
One vial contains 4 mg zoledronic acid, (as monohydrate).
Ena viala vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 μmol/l), zvišanje za
Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronska kislina Teva 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
- Increased sweating.
- zvečano znojenje - zaspanost,
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
EXP Use immediately after dilution.
Uporabite takoj po redčenju.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom > 265 μmol/l ali > 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Po več odmerkih, danih vsakih 28 dni, se zolendronska kislina ni kopičila v plazmi.
Hypocalcaemia has been reported in patients treated with Zoledronic Acid Teva.
Pri bolnikih, ki so prejemali zdravilo Zoledronska kislina Teva, so poročali o hipokalciemiji.
Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
akutna odpoved ledvic, hematurija, proteinurija redki:
Patients must be maintained well hydrated prior to and following administration of zoledronic acid.
Bolniki morajo biti pred dajanjem zoledronske kisline in po njem dobro hidrirani.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic Acid Teva therapy.
Po začetku zdravljenja z zdravilom Zoledronska kislina Teva moramo skrbno spremljati standardne presnovne parametre, povezane s hiperkalciemijo, kot so: serumske koncentracije kalcija, fosfata in magnezija.
Blood creatinine and blood urea increased, hypocalcaemia
zvišanje kreatinina in sečnine v krvi,
After dilution, it is preferable to use the diluted medicine immediately.
Po redčenju je najbolje raztopino za infundiranje uporabiti takoj.
How to store Zoledronic Acid Teva
Kako se daje zdravilo Zoledronska kislina Teva
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including;
Poleg tega obstajajo dokazi o povezanosti hipokalciemije in posledičnih nevroloških dogodkov, o katerih so poročali v teh primerih in so vključevali konvulzije, hipestezijo in tetanijo (glejte poglavje 4.4).
- Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
- pri bolnicah, ki so prejemale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
Name and address of the manufacturers responsible for batch release
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serije Pharmachemie B.V.
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion
Zoledronska kislina Teva 4 mg/5 ml koncentrat za raztopino za infundiranje
No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), s serumskim kreatininom < 400 μmol/l ali < 4,5 mg/dl,
Gastrointestinal disorders Common:
konjuktivitis občasni:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva B.V.
The expiry date refers to the last day of that month.
Navodilo je bilo nazadnje revidirano dne {MM/YYYY} Drugi viri informacij
Clear and colourless solution.
* zajema vertebralne in nevertebralne zlome
- Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
izzvenijo, - reakcije prebavil, na primer slabost s siljenjem na bruhanje (navzea) in bruhanje, pa tudi izguba teka,
NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Navodilo za uporabo Zoledronska kislina Teva 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Uncommon: Rare:
uveitis zelo redki:
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zoledronic Acid Teva.
O osteonekrozi čeljustnic so občasno poročali pri bolnikih, ki so prejemali zdravilo Zoledronska kislina Teva v kliničnih preskušanjih ali so se z njim zdravili po začetku trženja zdravila.
Treatment of TIH
IME ZDRAVILA
- Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
diuretike Henleyeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam,
Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with zoledronic acid.
Poročali so tudi o posameznih primerih osteonekroze na drugih lokacijah, vključno s kolkom in stegnenico.
Tell your doctor about any of the following side effects as soon as possible:
Čimprej povejte zdravniku za katerega koli od naslednjih neželenih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Če ste prejeli večji odmerek zdravila Zoledronska kislina Teva, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
What you need to know before you are given Zoledronic Acid Teva
Če dojite, vam ne smejo dati zdravila Zoledronska kislina Teva.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Teva 4 mg/5 ml sterile concentrate zoledronic acid
Zoledronska kislina Teva 4 mg/5 ml sterilni koncentrat zoledronska kislina i.v.
Sodium citrate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev citrat voda za injekcije
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C - 8°C .
Čas shranjevanja naj praviloma ne presega 24 ur pri 2 °C - 8 °C.
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
pa 17 dni (vrednosti p: 0,001 za 4 mg in 0,007 za 8 mg zoledronske kisline).
Uveitis
Dojenje
You should not be given Zoledronic Acid Teva if you are pregnant.
Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina Teva.
Gastrointestinal disorders Very common:
Bolezni prebavil zelo pogosti:
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Teva or after stopping treatment.
Če med zdravljenjem ali po zaključku zdavljenja z zdravilo Zoledronska kislina Teva pride do navedenih simptomov, takoj obvestite svojega zdravnika in zobozdravnika.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zoledronic Acid Teva therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Zoledronska kislina Teva, opisane primere hipokalciemije in posledičen razvoj aritmije.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Teva or after stopping treatment.
Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kislina Teva pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
Instructions for preparing reduced doses of Zoledronic Acid Teva Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose
- 4,4 ml za odmerek 3,5 mg - 4,1 ml za odmerek 3,3 mg - 3,8 ml za odmerek 3,0 mg
4 July 2015
4. julija 2015
Within 30 days following EC decision
V roku 30 dni od odločbe ES
This will highlight the risks and warnings of genotoxicity reactions.
V njem bodo poudarjena tveganja in opozorila v zvezi z genotoksičnimi učinki.
Thiocolchicoside takes part in the PSUR synchronisation project of the Heads of Medicine Agencies.
Tiokolhikozid je vključen v projekt uskladitve PSUR vodij agencij za zdravila.
The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Imetnik(i) dovoljenja za promet mora(jo) v okviru načrta za obvladovanje tveganja predložiti protokol za študijo o uporabi zdravila, namenjeno razjasnitvi prakse pri predpisovanju zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo zdravila, in opredelitvi glavnih razlogov za predpisovanje.
The MAHs should provide within the risk management plan educational material for prescribers and patients.
Imetniki dovoljenja za promet z zdravilom morajo v okviru načrta za obvladovanje tveganja predložiti izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo, in za bolnike.
The MAHs should submit a risk management plan (including outline of DUS and educational materials, see also below) in EU format.
Imetniki dovoljenja za promet z zdravilom morajo predložiti načrt za obvladovanje tveganja (vključno s povzetkom študije o uporabi zdravila in izobraževalnim gradivom; glejte tudi zahteve spodaj) v formatu EU.
The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP.
Imetniki dovoljenja za promet z zdravilom morajo v sodelovanju s pristojnimi nacionalnimi organi razdeliti neposredno obvestilo zdravstvenim delavcem (DHPC) v skladu z akcijskim načrtom, ki ga je potrdil CHMP.
8 vials Zero days
8 plastenke Nič dni.
Vial (type I glass)
≥ 10.53 log2 GMNU
Repeat at least three times.
Ponovite vsaj trikrat.
• Tell your doctor:
• Povejte zdravniku:
After first opening: 1 month.
Po prvem odprtju: 1 mesec
Study 020 24 weeks
Študija 020 24 tednov
** based on historical comparison
**temelji na pretekli primerjavi
• if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
• če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen z okvaro na srcu.
- any signs of inflammation or infection.
katere koli znake vnetja ali okužbe.
• Stocrin must be taken every day.
• Zdravilo Stocrin je treba jemati vsak dan.
Date of first authorisation: 28 May 1999 Date of latest renewal: 23 April 2014
Datum prve odobritve: 28. maj 1999 Datum zadnjega podaljšanja: 23. april 2014
Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar ni mogoče dati priporočila za odmerjanje.
Table 3: Efficacy results for study 006
Preglednica 3: Rezultati učinkovitosti za študijo 006
Children and adolescents (3 to 17 years)
Otroci in mladostniki (stari od 3 do 17 let)
After use, soak the syringe in warm soapy water for at least a minute.
Po uporabi namakajte brizgo v topli milnici vsaj eno minuto.
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1 %.
Pojavnost multiformnega eritema ali Stevens-Johnsonovega sindroma je bila približno 0,1 %.
Dose (ml) Children 3 - < 5 years
Odmerek (ml) Otroci 3 - < 5 let
---, not performed.
-, ni izvedeno.