natgillin/translations-raw huggingface dataset:
The manufacture, import, possession, sale, supply and/or use of Locatim may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation.
Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Locatim je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Zdravilo dajemo čimprej peroralno v odmerku 60 ml, najbolje prve štiri ure in ne kasneje kot 12 ur po telitvi.
PHARMACEUTICAL FORM Oral solution
FARMACEVTSKA OBLIKA
The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju pasivne imunosti, ni vključena v Uredbo(ES) št.
If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth.
Če tele zavrača zdravilo, lahko dajemo tekočino peroralno s pomočjo običajne brizge.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e):
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
PODATKI NA ZUNANJI OVOJNINI ŠKATLICA
The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.
LIECHTENSTEIN
KNEŽEVINA LIHTENŠTAJN
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
ROUTE(S) OF ADMINISTRATION
NAČIN IN POT(I) UPORABE
Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Dvojni odmerek zdravila lahko prehodno povzroči povečanje telesne temperature in pohitreno dihanje.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf's life, preferably, as soon as it is receptive.
Zdravilo dajemo nerazredčeno ali razredčeno z mlekom ali mlečnim nadomestkom v prvih 12 urah po telitvi.
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek zdravila lahko prehodno povzroči povečanje telesne temperature in pohitreno dihanje.
TARGET SPECIES Neonatal calves less than 12 hours of age.
CILJNE ŽIVALSKE VRSTE Novorojena teleta v starosti manj kot 12 ur.
NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim, oral solution for neonatal calves less than 12 hours of age
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Locatim peroralna raztopina za novorojena teleta v starosti manj kot 12 ur
BATCH NUMBER Batch {number}
ŠTEVILKA SERIJE lot {številka}
Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum LIECHTENSTEIN
Biokema Anstalt Pflugstrasse 12
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
(EU) št.37/2010 določa, da MRL ni potreben.
Any person intending to manufacture, import, possess, sell, supply and use Locatim must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Locatim, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
This product may contain antibodies against BVD virus.
Posebni previdnostni ukrepi za uporabo pri živalih Zdravilo lahko vsebuje protitelesa proti virusu goveje virusne diareje (BVD).
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Excipient
KARENCA
Fürstentum
OVOJNINAH
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
PACKAGE LEAFLET FOR: Locatim oral solution for neonatal calves less than 12 hours of age
NAVODILO ZA UPORABO Locatim peroralna raztopina za novorojena teleta v starosti manj kot 12 ur
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ml.
Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8*
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥2.8* log10/ml.
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8*
CONTRAINDICATIONS
ZDRAVILA
QUANTITY OF THE ACTIVE SUBSTANCE(S) Bovine concentrated lactoserum containing specific immunoglobulin G against E. coli F5(K99) adhesin >2.8 log10/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
69800 Saint Priest
9490 Vaduz
Not applicable.
UPORABE, ČE JE SMISELNO
MARKETING AUTHORISATION HOLDER
IMETNIK(I) DOVOLJENJ(A) ZA PROMET
60 ml.
log10/ml.
A.
DODATEK I
This usually takes approximately 60 seconds but can take up to 90 seconds.
To običajno traja približno 60 sekund, lahko pa traja do 90 sekund.
This helps to prevent infection.
To pomaga preprečiti okužbe.
It is important to use each dose at the scheduled time.
Pomembno je, da vsak odmerek uporabite ob načrtovanem času.
Subsequently, it may increase and become too high.
Nato se lahko raven zviša in je previsoka.
Effects were maintained throughout the 6-month follow-up period.
Učinki so se ohranili ves čas 6-mesečnega obdobja spremljanja.
No effect on safety or efficacy was observed.
Učinkov na varnost ali učinkovitost niso opazili.
The minimum effective dose should be used.
Uporabiti je treba najmanjši učinkoviti odmerek.
It is indicated in children and adolescents for long-term use.
Pri otrocih in mladostnikih je namenjeno za dolgotrajno uporabo.
Side effects can occur with the following frequencies:
Neželeni učinki se lahko pojavijo z naslednjimi pogostnostmi:
The clinical significance of this is unknown.
Klinični pomen tega učinka ni znan.
Follow the instructions carefully step by step.
Korak za korakom natančno sledite navodilom.
IGF-I levels should be acted upon, as indicated below.
Na ravni IGF-I se je treba odzvati, kot je navedeno spodaj.
Monitoring during treatment
Spremljanje med zdravljenjem
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2013
Datum prve odobritve: 05. avgust 2013
Samples should be drawn 4 days after the previous dose (Day 4).
Vzorci se jemljejo 4 dni po predhodnem odmerku (4. dan).
Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poland
Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poljska
The doctor will carefully monitor you during treatment as the effect of insulin may be reduced.
Zdravnik vas bo med zdravljenjem skrbno spremljal, saj se lahko učinek insulina zmanjša.
The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Natančnost odmerka rastnega hormona je zato treba preveriti vsakih 6 mesecev.
It is not known if this medicine passes into breast milk.
Ni znano, ali zdravilo prehaja v mleko.
Not known, frequency cannot be estimated from the available data - a reduced response to insulin (insulin resistance)
Neznana, pogostnosti ni mogoče oceniti iz razpoložljivih podatkov - zmanjšan odgovor na insulin (odpornost na insulin)
The suspension is for immediate single use only.
Suspenzija je samo za takojšnjo enkratno uporabo.
If you have used too much of this medicine, initially your blood sugar may decrease and become too low.
Če ste uporabili preveč tega zdravila, se lahko najprej ravni vašega krvnega sladkorja znižajo in postanejo prenizke.
If necessary, your doctor will gradually increase this dose according to your individual response to the treatment and your blood levels of a growth factor called IGF-I.
Po potrebi bo vaš zdravnik ta odmerek postopoma povečeval glede na vaš individualni odziv na zdravljenje in vaše ravni rastnega dejavnika, imenovanega IGF-I v krvi.
Do not use this medicine if you notice that it cannot be properly mixed.
Ne uporabljajte tega zdravila, če opazite, da ga ni mogoče pravilno premešati.
Biotransformation / Elimination
Biotransformacija / Izločanje
Individual doses may vary and your doctor will always prescribe the minimum effective dose based on your specific need.
Odmerki se za posameznega bolnika lahko razlikujejo, vaš zdravnik pa vam bo vedno predpisal najmanjši učinkoviti odmerek na podlagi vaših specifičnih potreb.
The dose will be calculated by your doctor as described below.
Odmerek bo izračunal zdravnik, kot je opisano spodaj.
Please also see the required adjustments described in section 2, ‘Other medicines and Somatropin Biopartners'.
Glejte tudi potrebne prilagoditve odmerkov, opisane v poglavju 2, »Druga zdravila in zdravilo Somatropin Biopartners«.
Treatment with this medicinal product should be continued until final height has been reached or until epiphyseal closure.
Zdravljenje s tem zdravilom morate nadaljevati do dosežene končne višine ali do zaprtja epifize.
If you are heavier than 40 kg, two vials must be used.
Če imate več kot 40 kg, sta potrebni dve viali.
If the thyroid is not working properly, this medicine may not work as well as it should.
Če ščitnica ne deluje pravilno, to zdravilo morda ne bo delovalo tako dobro, kot bi moralo.
It is not known how often this may occur, but if you suspect that this is the case, contact your doctor since the treatment may have to be stopped.
Ni znano, kako pogosto se lahko to pojavi, vendar se ob sumu na to posvetujte s svojim zdravnikom, saj bo morda treba zdravljenje ustaviti.
Growth hormone regulates the growth and development of cells.
Rastni hormon uravnava rast in razvoj celic.
Injections should always be given on the same day of the week and at the same time of day because it is easier to remember.
Injekcije si vedno dajajte na isti dan v tednu in tudi ob istem času tega dneva, da si lažje zapomnite.
After reconstitution: From a microbiological point of view, the product must be used immediately.
Po rekonstituciji: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
Your dose should be checked every 6 months by your doctor.
Zdravnik bo vsakih 6 mesecev preveril vaš odmerek.
Interruption or early stopping of treatment with this medicine may impair the success of the therapy.
Prekinitev ali predčasna ustavitev zdravljenja s tem zdravilom lahko ogrozi uspeh zdravljenja.
Reconstitution and dilution should be performed using aseptic techniques to ensure the sterility of the prepared suspension.
Rekonstitucija in redčenje morata potekati z aseptičnimi tehnikami, da se zagotovi sterilnost pripravljene suspenzije.
The suspension should appear uniform and white.
Suspenzija mora biti enotnega in belega videza.
In rabbits and monkeys no adverse effects were observed.
Pri kuncih in opicah niso opazili neželenih učinkov.
- Your doctor may check the level of sugar in your urine or blood since it may be affected by this
- Vaš zdravnik bo morda preverjal raven sladkorja v urinu ali krvi, saj lahko to zdravilo nanjo
The blood levels of IGF-I require regular monitoring so that they can be kept within the normal range for your age and gender.
Ravni rastnega dejavnika IGF-I v krvi je treba redno spremljati, da se jih lahko vzdržuje v razponu, normalnem za vašo starost in spol.
Wash your hands thoroughly with soap and water and dry them with a clean towel before preparing your injection.
Temeljito si umijte roke z milom in vodo, nato pa si jih pred pripravo injekcije osušite s čisto brisačo.
Benign intracranial hypertension
Benigna intrakranialna hipertenzija
Your doctor may decide upon a lower starting dose.
Vaš zdravnik se lahko odloči zmanjšati začetni odmerek.
• Somatropin must not be used for growth promotion in children with closed epiphyses.
• Somatropina se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami.
Do not touch the needle or allow it to come into contact with any surface prior to the injection.
Igle se ne dotikajte in ne dovolite, da pride pred injiciranjem v stik s katero koli površino.
D-72764 Reutlingen Germany
D-72764 Reutlingen Nemčija
Children below 2 years of age
Otroci, stari manj kot 2 leti
The dose may be reduced in steps of 0.5 mg at a time.
Odmerek se lahko naenkrat zmanjša v korakih po 0,5 mg.
These patients should be counselled on risks before initiating therapy.
Tem bolnikom je treba pred uvedbo zdravljenja svetovati glede teh tveganj.
Slowly withdraw the suspension.
Počasi izvlecite suspenzijo.
(the median nerve) becomes squeezed, resulting in hand numbness and pain - following use of the medicine over an extended period of time, particularly in men.
(mediani živec) stisne, kar povzroči omrtvelost in bolečino dlani - po dalj časa trajajoči uporabi zdravila, zlasti pri moških
It has 191 amino acid residues and a molecular weight of 22,125 Daltons.
Ima 191 aminokislinskih ostankov in molekulsko maso 22.125 daltonov.
figure 3b
Slika 3a
This medicine is used once a week.
To zdravilo se daje enkrat na teden.
Number of injections per dose
Število injekcij na odmerek
Remove the carton from the refrigerator.
Škatlo vzemite iz hladilnika.
Progression of scoliosis can occur in patients who experience rapid growth.
Napredovanje skolioze se lahko pojavi pri bolnikih, ki hitro rastejo.
Pack sizes:
Velikost pakiranja:
If you miss a dose, contact your doctor who will help establish a new dosing schedule.
Če izpustite odmerek, se obrnite na svojega zdravnika, ki vam bo pomagal določiti nov načrt odmerjanja.
Inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
Neustrezno zdravljenje hipotiroidizma lahko prepreči optimalni odziv na somatropin.
However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Vendar pa ni dokazov o večji pojavnosti levkemije pri prejemnikih rastnega hormona brez dejavnikov nagnjenosti.
- Inform the doctor if you begin to limp during treatment.
- Obvestite svojega zdravnika, če začnete med zdravljenjem šepati.
IGF-I SDS
SDS IGF-I
Additional reports based on published information for daily growth hormone treatments are listed with asterisks.
Dodatna poročila, ki temeljijo na objavljenih informacijah za vsakodnevno zdravljenje z rastnim hormonom, so označena z zvezdico.
This medicince is injected once a week.
To zdravilo se injicira enkrat na teden.
After the injection, growth hormone is slowly released into your body over a period of about a week.
Po injiciranju se rastni hormon počasi sprošča v telo, kar traja približno en teden.
Young adult patients with closed epiphyses who have previously been treated as children for GHD should be re-evaluated for GHD using the criteria for adult patients (see section 4.1) before replacement therapy is commenced at the doses recommended for adults.
Mlade odrasle bolnike z zaprtimi epifizami, ki so se predhodno kot otroci zdravili zaradi GHD, je treba ponovno oceniti za GHD s kriteriji za odrasle bolnike (glejte poglavje 4.1), preden se začne nadomestno zdravljenje z odmerki, priporočenimi za odrasle.
The most prominent effect of somatropin in children is the stimulation of the growth plates of long bones.
Najbolj poudarjen učinek somatropina pri otrocih je, da stimulira rastne plošče dolgih kosti.
In order to reach the defined treatment goal, men may need lower growth hormone doses than women.
Za dosego opredeljenega cilja zdravljenja utegnejo moški potrebovati manjše odmerke rastnega hormona od žensk.
Generally, 2 mg once a week for all patients apart from female patients receiving oral oestrogen therapy who should receive 3 mg once a week.
Na splošno je začetni odmerek 2 mg enkrat na teden za vse bolnike, razen za ženske, ki prejemajo peroralno estrogensko terapijo, ki naj prejmejo 3 mg enkrat na teden.
Do not inject this medicine yourself unless you have received training and you understand the procedure.
Tega zdravila si ne injicirajte, če o tem niste bili ustrezno poučeni in če ne razumete postopka.
+1.5 mg (female on oral oestrogen) +1.0 mg (all other patients)
+1,5 mg (ženske, ki dobivajo peroralni estrogen) +1,0 mg (vsi drugi bolniki)
Detailed information on how to administer this medicinal product is provided in section 3 of the patient leaflet.
Podrobne informacije o dajanju tega zdravila najdete v poglavju 3 navodila za bolnika.
Thyroxine replacement therapy may therefore need to be initiated or adjusted.
Morda bo treba uvesti ali prilagoditi nadomestno zdravljenje s tiroksinom.
The recommended weekly dose in children (i.e. 0.5 mg/kg/week) should not be exceeded as there is limited experience with higher doses in this patient group.
Priporočenega tedenskega odmerka za otroke (tj. 0,5 mg/kg/teden) ni dovoljeno prekoračiti, saj je izkušenj z višjimi odmerki pri tej skupini bolnikov malo.
Experience with somatropin treatment in patients above 60 years of age is limited.
Izkušenj z zdravljenjem bolnikov, starejših od 60 let, je malo.
-0.5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score.
-0,5 mg (vsi bolniki) IGF-I = insulinu podobni rastni dejavnik-I, SDS = standardni odklon.
With the exception of injection site related reactions and the formation of antibodies to rhGH which were reported more frequently in children than in adults the safety profile of Somatropin Biopartners is similar for children and adults.
Z izjemo reakcij na mestu injiciranja in nastajanjem protiteles proti rhGH, o katerih so pogosteje poročali pri otrocih kot pri odraslih, je profil varnosti zdravila Somatropin Biopartners za otroke in odrasle podoben.
Remove the protective caps from the top of both vials as seen in figure 3a.
Odstranite zaščitni zaporki z obeh vial, kot je prikazano na sliki 3a.
- If you have had a tumour your doctor will examine you before and regularly during treatment.
- Če ste imeli tumor, vas bo zdravnik pregledal pred zdravljenjem in jih nato med zdravljenjem redno pregledovati.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 ºC - 8 ºC).
Vials and solvent required for preparation of one dose*
Viale in vehikel, potrebni za pripravo enega odmerka*
This medicine should not be used in infants below the age of 2 years.
Tega zdravila ne uporabljajte pri dojenčkih, starih manj kot 2 leti.
Due to the prolonged-release characteristics of this medicinal product peak levels of growth hormone can be expected approximately 15 hours after injection, see section 5.2.
Zaradi podaljšanega sproščanja tega zdravila se pričakovane najvišje ravni rastnega hormona pojavijo približno 15 ur po injiciranju, glejte poglavje 5.2.
If the symptoms leading to the dose reduction disappear, at the judgment of the physician, the dose may be maintained at the decreased level or increased according to the dose adjustment scheme described above.
Če simptomi, zaradi katerih je bil odmerek zmanjšan, izginejo, je mogoče odmerek po presoji zdravnika ohraniti na zmanjšani ravni ali pa ga povečati v skladu z zgoraj opisano shemo prilagajanja odmerka.
In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Ob upoštevanju tega ni verjetno, da bi bilo potrebno nadaljevanje nadomestnega zdravljenja s somatropinom pri ženskah s pomanjkanjem rastnega hormona v tretjem trimesečju nosečnosti.
In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the treatment goal, see section 4.2.
Pri ženskah, ki jemljejo peroralne estrogene, bodo morda potrebni višji odmerki somatropina, da se doseže cilj zdravljenja, glejte poglavje 4.2.
Some patients may develop antibodies to rhGH.
Pri nekaterih bolnikih se lahko razvijejo protitelesa proti rhGH.
If you are injecting this medicine yourself you will be shown how to prepare and give the injection.
Če si zdravilo injicirate sami, vam bodo pokazali, kako si ga pravilno pripravite in injicirate.
Similar results were achieved for all other parameters assessed including height SDS (standard deviation score), bone maturation, IGF-I and IGF BP-3.
Podobne rezultate so dosegli za vse druge ocenjene parametre, vključno s standardnim odklonom (SDS, Standard Deviation Score), zrelostjo kosti, IGF-I in IGF BP-3.
In particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Svojega zdravnika še zlasti obvestite, če jemljete ali ste pred kratkim jemali katero od spodaj navedenih zdravil.
Initially, patients should have their IGF-I levels assessed at 3- to 4-weekly intervals until IGF-I SDS is in the target range of -0.5 to +1.5.
Na začetku je treba pri bolnikih oceniti ravni IGF-I v 3- do 4-tedenskih intervalih, dokler ni SDS IGF-I v ciljnem razponu od -0,5 do +1,5.
Side effects were generally transient and mild to moderate.
Neželeni učinki so bili na splošno prehodni in blagi do zmerni.
Conversion from patient body weight to dose, number of vials, total injection volume and number of injections in paediatric patients
Pretvorba s telesne mase bolnika v odmerek, število vial, skupni volumen injiciranja in število injekcij pri pediatričnih bolnikih
If the symptom reappears after the dose increase, then the dose should be maintained at the previous lower dose.
Če se simptomi po povečanju odmerka ponovno pojavijo, je treba ohraniti prejšnji nižji odmerek.
Few patients discontinued treatment due to injections site reactions.
Nekaj bolnikov je zdravljenje prekinilo zaradi reakcij na mestu injiciranja.
Inject the medicine as instructed by your doctor who will also tell you what dose to use and how to inject this dose with the vials you have been prescribed.
Zdravilo si injicirajte po navodilih zdravnika, ki vam bo povedal tudi, kolikšen odmerek morate uporabiti in kako si morate ta odmerek injicirati z vialami, ki so vam bile predpisane.
At present, there is insufficient evidence to guide clinical decision-making in patients with resolved intracranial hypertension.
Trenutno ni dovolj dokazov za vodenje kliničnega odločanja pri bolnikih z odpravljeno intrakranialno hipertenzijo.
Few patients discontinued treatment due to injections site reactions, see section 4.8.
Nekaj bolnikov je zdravljenje prekinilo zaradi reakcij na mestu injiciranja, glejte poglavje 4.8.
When it stimulates the growth of cells in the long bones of the legs and spine, it causes an increase in height.
S spodbujanjem rasti celic v dolgih kosteh nog in v hrbtenici povzroči povečanje telesne višine.