natgillin/translations-raw huggingface dataset:
Individual benefit/risk justification 
Presoja razmerja med tveganji in koristmi pri posameznem bolniku
Connect the male luer of the outlet line of the 68Ge/68Ga generator with a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity tracenot supplied). 
Moški del konice Luer odvoda generatorja 68Ge/68Ga povežite s sterilno iglo (prevlečeno s silikonom ali drugega ustreznim materialom za zmanjšanje sledov kovinskih nečistoč ta ni priložena zdravilu).
Non-clinical data did not reveal any special hazard for gallium (68Ga) edotreotide in humans. 
5.3 Predklinični podatki o varnosti Neklinični podatki ne kažejo nobenega posebnega tveganja za uporabo [68Ga]galij-edotreotida pri ljudeh.
Depending on the time when you administer the injection, the content of sodium may in some cases be greater than 1 mmol. 
Vsebnost natrija je lahko v nekaterih primerih večja od 1 mmol, kar je odvisno od časa injiciranja.
Finally remove the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier. 
Na koncu odstranite 0,2-µm sterilni odzračevalni filter ter vialo s kleščami prestavite na odprtino suhe kopeli pri 95 °C.
Connect the Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum. 
Povežite vialo 1 z odvodom generatorja, tako da iglo potisnete skozi gumijasto tesnilo.
After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases. 
[68Ga]galij-edotreotida indicirana za slikanje čezmerne ekspresije somatostatinskih receptorjev s pozitronsko emisijsko tomografijo (PET) pri odraslih bolnikih s potrjenimi ali domnevnimi dobro diferenciranimi gastroenteropankreatičnimi nevroendokrinimi tumorji (GEP-NET) za lokalizacijo primarnih tumorjev in njihovih metastaz.
d. Scan the ITLC with a radiometric ITLC scanner e. The retention factor (Rf) specifications are as follows: Not complexed gallium (68Ga) = 0 to 0.1 gallium (68Ga) edotreotide = 0.8 to 1 
e. Lastnosti retencijskega faktorja (Rf) so naslednje: Nekompleksiran galij (68Ga) = 0-0,1 [68Ga]galij-edotreotid = 0,8-1
Urinary bladder wall Uterus 
Ščitnica Stena sečnega mehurja
Table 1: Dosimetry of gallium (68Ga) edotreotide 
Preglednica 1: Dozimetrija [68Ga]galij-edotreotida
Connect Vial 1 through the 0.2 µm sterile vent filter to a vacuum vial or to a pump to start the elution. 
Vialo 1 preko 0,2-µm sterilnega odzračevalnega filtra povežite z vakuumsko vialo ali črpalko, da začnete z eluacijo.
High physiological uptake of gallium (68Ga) edotreotide by the pancreas uncinate process can also be observed. 
Visok fiziološki privzem [68Ga]galij-edotreotida je opazen tudi v uncinatnem procesusu trebušne slinavke.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the fœtus. 
Podatki o uporabi tega zdravila med nosečnostjo ni. Radionuklidni postopki, opravljeni na nosečnicah, vključujejo tudi odmerke sevanja na plod.
monograph 2464 Gallium (68Ga) chloride solution for radiolabelling and that, in addition, is sterile and has been tested for compatibility with SomaKit TOC. 
Namenjen je radioaktivnemu označevanju z raztopino [68Ga]galijevega klorida, skladno z monografijo Ph. Eur št. 2464 - raztopina [68Ga]galijevega klorida za radioaktivno označevanje, poleg tega mora biti sterilna ter preskušeno združljiva z zdravilom SomaKit TOC.
In the study of Kowalski et al. 2003 in 4 patients with GEP-NET, gallium (68Ga) edotreotide showed better patient-based detection rate (100%) than indium (111In) pentetreotide (50%). 
V študiji Kowalski et al. 2003 s 4 bolniki z GEP NET je bila stopnja odkrivanja pri posameznem bolniku pri [68Ga]galij-edotreotidu boljša (100 %) kot pri [111In]indij-pentetreotidu (50 %).
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials. 
Radiofarmake bodo shranjevali v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
The organ uptake has been shown to be age-independent in normal adult human tissues and also predominantly gender-independent (except for the thyroid and head of pancreas). 
Izkazalo se je, da je privzem v organih neodvisen od starosti in tudi pretežno neodvisen od spola
• One vial of buffer: 10 ml cyclic olefin polymer vial closed with a teflon stopper and sealed with a flip-off cap. Each vial contains 1 ml of reaction buffer. 
• Ena viala s pufrom: 10-mililitrska steklena viala iz cikličnega olefin polimera s teflonskim zamaškom, zatesnjenim z zaporko (tipa »flip-off«).
b. Apply a drop of the gallium (68Ga) edotreotide solution on a pencil line 1 cm from the bottom of the ITLC strip. 
b. Kapljo raztopine [68Ga]galij-edotreotida nanesite na črto svinčnika 1 cm od spodnjega roba traka ITLC.
Talk to your nuclear medicine specialist before you are given SomaKit TOC: - if you experience any signs of allergic reaction (listed in section 4) after previous administration of SomaKit TOC; - if you have kidney or liver problems (renal or hepatic disease); - if you are under 18 years of age; - if you have signs of dehydration before and after the examination; 
- če imate težave z ledvicami ali jetri (ledvično ali jetrno bolezen); - če ste mlajši od 18 let; - če imate znake dehidracije pred in po pregledu;
Symptoms may include: warm flush, redness of the skin, swelling, itching, nausea and difficulty breathing. 
Simptomi lahko vključujejo: vročinske oblive, pordelost kože,
Paediatric population The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults. 
Varnost in učinkovitost [68Ga]galij-edotreotida pri pediatrični populaciji nista bili dokazani, učinkoviti odmerek pa je lahko drugačen, kot pri odraslih.
With a 5 mL sterile syringe and a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity trace - not supplied) carefully withdraw 4 mL of water for injections (not supplied) and reconstitute the powder in Vial 1. 
S sterilno 5-ml injekcijsko brizgo in sterilno iglo (prevlečeno s silikonom ali drugim ustreznim materialom za zmanjšanje sledov kovinskih nečistoč - ta ni priložena zdravilu)
EXP After radiolabelling, use within 4 hours. 
Po radioaktivnem označevanju porabit v 4 urah.
Reconstitution with GalliaPharm generator: a. 
Rekonstitucija z generatorjem GalliaPharm:
Therefore, when treating patients with somatostatin analogues, it is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) preceding the next administration of a somatostatin analogue. 
Zato je treba pri zdravljenju bolnikov s somatostatinskimi analogi slikanje z [68Ga]galij-edotreotidom po možnosti opraviti dan (nekaj dni) pred naslednjim dajanjem analoga somatostatina.
A low dead space 1 ml plastic syringe must be used in order to precisely measure the adequate volume of reaction buffer to be added during the preparation. 
Za natančno merjenje zadostne količine pufra za reakcijo, ki ga je treba dodati med pripravo, je treba uporabiti 1-ml plastično injekcijsko brizgo z majhnim volumnom mrtvega prostora.
However, after gallium (68Ga) chloride solution is added, adequate shielding of the final preparation must be maintained. 
[68Ga]galijevega klorida, pa je treba ves čas uporabljati ustrezno zaščito pred sevanjem končnega pripravka.
Data available on clinical efficacy of gallium (68Ga) edotreotide for the indication of predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited. 
Razpoložljivi podatki glede klinične učinkovitosti [68Ga]galij-edotreotida za indikacijo predvidevanja in spremljanja terapevtskega odziva na radionuklidno terapijo s peptidnimi receptorji (PRRT) v histološko potrjenem metastatskem NET, so omejeni (glejte poglavje 5.1).
As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas). 
neoplazije pljuč (drobnocelični karcinom), meningiomi, karcinomi dojk, limfoproliferativna bolezen (npr. Hodgkinova bolezen in ne-Hodgkinovi limfomi) in tumorji, ki izhajajo iz tkiva, ki embriološko izhaja iz nevralnega grebena (npr. paragangliomi, medularni karcinomi ščitnice, nevroblastomi, feokromocitomi).
For radiolabelling with gallium (68Ga) chloride solution. 
Za radioaktivno označevanje z raztopino [68Ga]galijevega klorida.
The visual inspection should be performed under a shielded screen for radioprotection purposes. 
Pregled je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
How SomaKit TOC is stored 6. 
Shranjevanje zdravila SomaKit TOC 6.
If possible, for more convenience in the preparation of radiolabelled SomaKit TOC, the heating platform should be placed right beside the generator. 
SomaKit TOC grelno platformo postavite neposredno ob generator.
Before administration of SomaKit TOC 
Pred uporabo zdravila SomaKit TOC
Close contact with infants should be restricted during the initial 8 hours following injection. 
V prvih 8 urah po dajanju tega zdravila je treba omejiti tesne stike z dojenčkom.
Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment. 
Varnosti in učinkovitosti [68Ga]galij-edotreotida niso preučevali pri bolnikih z okvaro ledvic ali jeter.
Lesion-detection rate was 75% (3/4) in the subgroup of patients with unknown primary tumour site of the prospective study of Frilling et al. 2010. 
V prospektivni študiji Frilling et al. 2010 je bila stopnja odkrivanja lezij 75 % (3/4) za podskupino bolnikov z neznanim mestom primarnega tumorja.
Withdraw the syringe and the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier. 
Izvlecite injekcijsko brizgo in 0,2-µm sterilni odzračevalni filter ter vialo s kleščami prestavite na odprtino suhe kopeli pri 95 °C.
b. Apply a drop of the gallium (68Ga) edotreotide on a pencil line 1 cm from the bottom of the 
b. Kapljo [68Ga]galij-edotreotida nanesite na črto svinčnika 1 cm od spodnjega roba traka
Administration of SomaKit TOC and conduct of the procedure After radiolabelling, SomaKit TOC is administered by intravenous injection. 
Zdravilo SomaKit TOC se po radioaktivnem označevanju daje z intravensko injekcijo.
• One vial of powder for solution for injection: 10 ml Type I glass vial closed with a bromobutyl rubber stopper and sealed with a flip-off cap. Each vial contains 40 micrograms of edotreotide. 
• Ena viala s praškom za raztopino za injiciranje: 10-mililitrska steklena viala (steklo tipa I) z zamaškom iz bromobutilne gume, zatesnjenim z zaporko (tipa »flip-off«).
m. The solution should be visually inspected prior to use. 
m. Raztopino je treba pred uporabo pregledati.
In the study of Lee et al. 2015 in 13 GEP-NET patients, a total of 35 positive lesions were detected in 10 patients on either gallium (68Ga) edotreotide PET/CT or indium (111In) pentetreotide 
V študiji Lee et al. 2015 je bilo pri 13 bolnikih z GEP NET odkritih skupno 35 pozitivnih lezij pri 10 bolnikih, tako s PET/CT z [68Ga]galij-edotreotidom kot tudi s SPECT/CT z [111In]indij-pentetreotidom, medtem ko pri 3 bolnikih niso odkrili nobene pozitivne lezije z nobeno od metod slikanja.
Figure 1: Radiolabelling procedure when using GalliaPharm generator Reconstitution with Galli Ad generator: 
Slika 1: Postopek radioaktivnega označevanja pri uporabi generatorja GalliaPharm
What SomaKit TOC looks like and contents of the pack SomaKit TOC is a kit for radiopharmaceutical preparation containing: - A glass vial with black flip-off cap containing a white powder. 
Izgled zdravila SomaKit TOC in vsebina pakiranja SomaKit TOC je komplet za pripravo radiofarmaka, ki vsebuje:
SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation Edotreotide 
SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka edotreotid
Renal / Hepatic impairment 
Bolniki z ledvično ali jetrno okvaro
After radiolabelling, store below 25°C. 
Po radioaktivnem označevanju shranjujte pri temperaturi do 25 ºC.
NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation 
IME ZDRAVILA SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka
Radiolabelled SomaKit TOC is suitable for PET medical imaging. 
Radioaktivno označeno zdravilo SomaKit TOC je primerno za medicinsko slikanje s PET. Zajemanje mora vključevati celo telo od lobanje do sredine stegen.
Appearance 
Videz
Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68 
Učinkovitost označevanja vzorec koloidnega galija-68
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. 
Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba skrbno pretehtati razmerje med koristmi in tveganji .
No adverse reactions related to gallium (68Ga) edotreotide have been reported. 
4.8 Neželeni učinki O neželenih učinkih, povezanih z [68Ga]galij-edotreotidom, niso poročali.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide 
IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC 40 mikrogramov raztopina za injiciranje [68Ga]galij-edotreotid intravenska uporaba
The three remaining retrospective studies recruited small samples (ranging from 20 to 28 GEP-NET patients or those with cancer of unknown origin) and found that semiquantitative uptake in the pre-PRRT gallium (68Ga) 
Preostale tri retrospektivne študije so uporabljale majhne vzorce (v razponu od 20 do 28 bolnikov z GEP NET ali bolnikov z rakom neznanega izvora) in so ugotovile, da je bil semikvantitativni privzem pri slikanju PET z [68Ga]galij edotreotidom pred PRRT povezan z odmerki, ki jih tumor absorbira ob vbrizganju v naslednjem prvem ciklu zdravljenja, da je pomagal pri razlikovanju med lezijami, opredeljenimi kot odzivnimi in neodzivnimi po treh ciklih PRRT, ter da je pomagal razlikovati metastaze v jetrih od normalnega jetrnega tkiva.
No radioactive metabolites were detected in serum within 4 hours after intravenous injection of gallium (68Ga) edotreotide. 
V 4 urah po intravenskem injiciranju [68Ga]galij-edotreotida niso odkrili readioaktivnih presnovkov v serumu.
How SomaKit TOC is used 
Kako uporabljati zdravilo SomaKit TOC
A lesion detection rate of 100% (40/40) versus 85% (34/40) was observed in the study of Hofmann et al. 2001 recruiting patients with histologically proven bronchial (n=2) or midgut (n=6) NETs. 
V študiji Hofmann et al. 2001, ki je obravnavala bolnike s histološko dokazanimi NET bronhijev (n=2) in srednjega črevesa (n=6), so zaznali stopnjo odkrivanja lezij 100 % (40/40) v primerjavi s 85 % (34/40).
Store the vial containing the gallium (68Ga) edotreotide solution below 25°C until use. 
Vialo z [68Ga]galij-edotreotidom do uporabe hranite pri temperaturi do 25 °C.
What you need to know before SomaKit TOC is used 
Kaj morate vedeti, preden boste uporabili zdravilo SomaKit TOC Zdravila SomaKit TOC se ne sme uporabljati:
ITLC strip. 
ITLC.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms powder for solution for injection edotreotide 
IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC 40 mikrogramov prašek za raztopino za injiciranje edotreotid i.v.
Formic acid 
Stena želodca
Free gallium-68 = 0.9 to 1 
% prostega galija-68
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
Powder: 1,10-phenanthroline, gentisic acid, mannitol (E421) Buffer: formic acid, sodium hydroxide (E524), water for injections See leaflet for further information. 
Pufer: mravljinčna kislina, natrijev hidroksid (E524), voda za injekcije
GENERAL CLASSIFICATION FOR SUPPLY 
Komplet v embalaži za prodajo
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SHIELD LABEL TO BE APPLIED AFTER RADIOLABELLING 
NALEPKA ZA ŠČIT, KI JO JE TREBA NALEPITI PO RADIOAKTIVNEM OZNAČEVANJU
This medicinal product should be radiolabelled before administration to the patient. 
Preden se zdravilo da bolniku, ga je treba radioaktivno označiti.
Do not store above 25°C after radiolabelling. 
Po radioaktivnem označevanju shranjujte pri temperaturi do 25°C.
A schematic representation of the radiolabelling procedure is shown in 
Shematski prikaz postopka radioaktivnega označevanja je prikazan na sliki 1.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Concomitant use of somatostatin analogues It is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) before the next administration of a somatostatin analogue. 
Slikanje z [68Ga]galij-edotreotidom je treba po možnosti opraviti dan (nekaj dni) pred naslednjim dajanjem analoga somatostatina.
How SomaKit TOC is stored 
Shranjevanje zdravila SomaKit TOC
SomaKit TOC contains sodium 
Zdravilo SomaKit TOC vsebuje natrij.
For the detection of the primary GEP-NET site in case of rising levels of a relevant biochemical tumour marker or in case of proven NET metastasis, patient-based sensitivity and specificity of gallium (68Ga) edotreotide PET were 100% (4/4) and 89% (8/9), respectively, in the prospective study of Gabriel et al. 2007. 
NET, od bolnika odvisni občutljivost in specifičnost PET z [68Ga ]galij-edotreotidom 100 % (4/4) oziroma 89 % (9/8).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 40 micrograms of edotreotide. 
Ena viala vsebuje 40 mikrogramov edotreotida.
OTHER Do not store above 25ºC 
DRUGI PODATKI Shranjujte pri temperaturi do 25 °C.
You must inform the nuclear medicine doctor before the administration of SomaKit TOC if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. 
Če obstaja možnost, da ste noseči, vam je izostala menstruacija ali dojite, o tem pred uporabo zdravila SomaKit TOC obvestite zdravnika nuklearne medicine.
Pregnancy and breast-feeding 
OVOJNINAH VIALA S PUFROM
This will help protect the environment. 
Takšni ukrepi pomagajo varovati okolje.
However, the risk of transmission is still possible. 
Toda tveganje prenosa še obstaja.
Your doctor will discuss this with you. 
Zdravnik se bo o tem z vami pogovoril.
• you are over 65 years of age 
• če ste starejši od 65 let,
The CHMP found the new proposal acceptable. 
CHMP je menil, da je novi predlog sprejemljiv.
75014 PARIS France 
75014 PARIS Francija
The extent of exposure in this population is difficult to quantify. 
Obseg izpostavljenosti v tej populaciji je težko količinsko opredeliti.
The estimated daily AUCs are appreciably greater. 
Ocenjene dnevne AUC so občutno večje.
The level of information differs across Members States. 
Raven informacij se razlikuje med državami članicami.
For maximum clinical benefit, the treatment should be started within 48 hours. 
Za največjo klinično korist je treba zdravljenje začeti v 48 urah.
Symptoms and Signs 
Simptomi in znaki
Specific documentation was submitted taking into account updated data. 
Predložil je specifično dokumentacijo, v kateri je upošteval posodobljene podatke.
A recent metaanalysis (Lebrun-Vignes, 2007) provided additional supportive data for this indication. 
Nedavna metaanaliza (Lebrun-Vignes, 2007) daje dodatne podporne podatke za to indikacijo.
Some Member States have recommendations of a higher dose than other member states in specific situations. 
Nekatere države članice imajo v specifičnih situacijah priporočene večje odmerke kot druge države članice.
Rapid development of symptoms including: 
Hiter nastanek simptomov, med katerimi so:
• seeing or hearing things that aren't there (hallucinations) 
• videnje ali slišanje stvari, ki jih ni (halucinacije),
Nevertheless, given the relatively benign indication, a conservative approach might be appropriate to reduce the potential safety risk. 
Kljub temu izgleda, da bo glede na relativno benigno indikacijo konzervativni pristop primeren za zmanjšanje potencialnega varnostnega tveganja.
169 29 Solna, Sweden 
169 29 Solna, Švedska
These observations support safety of treatment of HSV in both groups although the possibility of increasing resistance should continuously be observed. 
Ta opažanja podpirajo varnost zdravljenja HSV v obeh skupinah, vendar je treba stalno spremljati možnost povečanja odpornosti.
105 Reykjavík, Iceland 
105 Reykjavík, Islandija
Similar type of data is presented but the level of factual detail varies significantly. 
Predstavljeni so podobni podatki, vendar se raven podrobnosti zelo razlikuje.
The CHMP adopted a List of Questions on 20 November 2008 and other three Lists of outstanding issues. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je dne 20. novembra 2008 sprejel seznam vprašanj ter tri druge sezname nerešenih vprašanj.
This is important to prevent you passing the infection on to others. 
To je pomembno, da ne boste okužbe prenesli na druge.
Patients should be observed closely for signs of toxicity. 
Bolnike je treba natančno opazovati glede znakov toksičnosti.
The data were therefore not sufficient for subgroup analyses of efficacy and safety. 
Podatki zato niso zadostovali za analizo učinkovitosti in varnosti v podskupinah.
Recommendations for use also show differences. 
Razlikujejo se tudi priporočila za rabo.
• fall in blood pressure leading to collapse. 
• padec krvnega tlaka, ki povzroči kolaps.
Treatment should be re-evaluated after 6 to 12 months of therapy. 
Zdravljenje je treba ponovno oceniti po 6 do 12 mesecih zdravljenja.
Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Valtrex 
To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija, Bolgarija, Ciper, Češka, Estonija, Finska, Nemčija, Grčija, Islandija, Irska, Latvija, Litva, Malta, Norveška, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska, Velika Britanija: Valtrex
30 to 49 10 to 29 
30 do 49 10 do 29
Analysis of the published literature showed no new significant safety concerns for the babies or the mothers. 
Analiza objavljenih podatkov ni pokazala novih pomembnih varnostnih zadržkov za dojenčke ali matere.
Creatinine clearance estimates were similar between treatments and between the two studies. 
Ocene očistka kreatinina so bile podobne med zdravljenji in med obema študijama.
The CHMP considered that only studies of limited size and unknown quality have been reported. 
CHMP je menil, da so bile predložene le študije omejene velikosti in neznane kakovosti.
The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients. 
Zdravljenje običajno traja 90 dni, vendar je lahko pri bolnikih z velikim tveganjem potrebno podaljšanje.
FI-02200 Espoo, Finland 
FI-02200 Espoo, Finska
It is very important while you are taking Valtrex that you drink water regularly during the day. 
Zelo pomembno je, da medtem, ko jemljete zdravilo Valtrex, čez dan redno pijete vodo.
Creatinine Clearance (mL/min) 
Očistek kreatinina (ml/min)
152 32 Halandri, Athens, Greece 
152 32 Halandri, Athens, Grčija
Although rare, this is thought to be associated with high peak concentrations rather than AUC. 
Čeprav je to redko, naj bi bilo povezano z visokimi vrhovi koncentracij in ne z vrednostjo AUC.