natgillin/translations-raw huggingface dataset:
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Francija Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Annopol 6B - 03-236 Warszawa, Poland
Annopol 6B - 03- 236 Warszawa, Poljska
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Valdoxan are provided with educational materials containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vse osebe, pooblaščene za predpisovanje/ uporabo zdravila Valdoxan, dobile izobraževalno gradivo z naslednjo vsebino.
Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, rue Garnier 92200 Neuilly- sur- Seine Francija
What Valdoxan is and what it is used for 2.
Kaj je zdravilo Valdoxan in za kaj ga uporabljamo 2.
Before you take Valdoxan 3.
Kaj morate vedeti, preden boste vzeli zdravilo Valdoxan 3.
How to take Valdoxan 4.
Kako jemati zdravilo Valdoxan 4.
Possible side effects 5 How to store Valdoxan 6.
Shranjevanje zdravila Valdoxan 6.
WHAT VALDOXAN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO VALDOXAN IN ZA KAJ GA UPORABLJAMO
Valdoxan belongs to a group of medicines called antidepressants and you have been given Valdoxan to treat your depression.
Zdravnik vam ga je predpisal za zdravljenje depresije.
BEFORE YOU TAKE VALDOXAN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO VALDOXAN
Do not take Valdoxan
Ne jemljite zdravila Valdoxan
- if you are allergic (hypersensitive) to agomelatine or any of the other ingredients of Valdoxan (see
- če ste alergični (preobčutljivi) na agomelatin ali katerokoli sestavino zdravila Valdoxan (glejte
‘ What Valdoxan contains ’ in section 6).
» Kaj vsebuje zdravilo Valdoxan « v poglavju 6),
ciprofloxacin (an antibiotic).
- če vaša jetra ne delujejo pravilno (jetrna okvara).
- if your liver does not work properly (hepatic impairment).
Bodite posebno pozorni pri jemanju zdravila Valdoxan V nekaterih primerih zdravilo Valdoxan ni ustrezno za vas:
Take special care with Valdoxan There could be some reasons why Valdoxan may not be suitable for you:
Če ste že doživeli manične simptome ali jih začnete opažati (obdobje pretirane vznesenosti in
- If you have already experienced or if you develop manic symptoms (a period of abnormally high
-
Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Pri nekaterih bolnikih se lahko vrednost jetrnih encimov med jemanjem zdravila Valdoxan zveča.
Based on the evaluation of these tests the doctor will decide whether you should continue using Valdoxan or not (see also under “ How to take Valdoxan ” in section 3).
Glede na rezultate preiskav se bo zdravnik odločil, če boste nadaljevali z jemanjem zdravila Valdoxan ali ne (glejte tudi » Kako jemati zdravilo Valdoxan « v poglavju 3).
safe for you to take Valdoxan.
Valdoxan varno.
Valdoxan is not intended for use in children and adolescents (under 18 years old).
Zdravilo Valdoxan ni namenjeno otrokom in mladostnikom, mlajšim od 18 let.
You should not take Valdoxan together with certain medicines (see also under “ Do not take Valdoxan ” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic).
Zdravila Valdoxan ne smete jemati sočasno z določenimi zdravili (glejte tudi » Ne jemljite zdravila Valdoxan « v poglavju 2): fluvoksaminom (še enim zdravilom za zdravljenje depresije), ciprofloksacinom (antibiotikom).
Taking Valdoxan with food and drink Valdoxan can be taken with or without food.
Jemanje zdravila Valdoxan skupaj s hrano in pijačo Zdravilo Valdoxan lahko jemljete s hrano ali brez nje.
Pregnancy Talk to your doctor if you become pregnant (or plan to become pregnant) while you are taking Valdoxan.
Nosečnost Če med zdravljenjem z zdravilom Valdoxan zanosite ali načrtujete nosečnost, povejte zdravniku.
Breast-feeding Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Valdoxan.
Če jemljete zdravilo Valdoxan, morate namreč prenehati z dojenjem.
20 This medicine contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Valdoxan To zdravilo vsebuje laktozo.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Valdoxan.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo zdravila Valdoxan posvetujte s svojim zdravnikom.
HOW TO TAKE VALDOXAN
KAKO JEMATI ZDRAVILO VALDOXAN
Always take Valdoxan exactly as your doctor has told you.
Pri jemanju zdravila Valdoxan natančno upoštevajte zdravnikova navodila.
Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
20 Pri večini bolnikov zdravilo Valdoxan začne zmanjševati simptome depresije v dveh tednih po začetku zdravljenja.
If you take more Valdoxan than you should If you have taken more Valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Valdoxan, kot bi smeli Če ste vzeli večji odmerek zdravila Valdoxan, kot bi smeli, ali če je na primer zdravilo nehote vzel otrok, takoj obvestite svojega zdravnika.
The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach and drowsiness.
Izkušnje s prevelikim odmerjanjem zdravila Valdoxan so omejene, poročali pa so o simptomih, kot so bolečine v zgornjem delu želodca in zaspanost.
If you forget to take Valdoxan Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Valdoxan Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Like all medicines, Valdoxan can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Valdoxan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
21 The frequency of possible side effects listed below is defined using the following system: • very common (affects more than 1 user in 10) • common (affects 1 to 10 users in 100) • uncommon (affects 1 to 10 users in 1,000) • rare (affects 1 to 10 users in 10,000) • very rare (affects less than 1 user in 10,000) • not known (frequency cannot be estimated from the available data)
Pogostnost morebitnih neželenih učinkov, ki so navedeni spodaj, je definirana na naslednji način:
- Uncommon side effects: pins and needles in the fingers and toes (paraesthesia), blurred vision and
Občasni neželeni učinki: mravljinčenje in zbadanje v prstih na rokah ter nogah (parestezije),
HOW TO STORE VALDOXAN
SHRANJEVANJE ZDRAVILA VALDOXAN
Do not use Valdoxan after the expiry date which is stated on the carton and blister.
Zdravila Valdoxan ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
What Valdoxan contains
Kaj vsebuje zdravilo Valdoxan
What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets are oblong, orange-yellow with a blue imprint of ‘ company logo ’ on one side.
filmska obloga: hipromeloza, glicerol, makrogol, magnezijev stearat, rumeni železov oksid (E172), titanov dioksid (E171);
Valdoxan 25 mg film-coated tablets are available in calendar blisters.
Izgled zdravila Valdoxan in vsebina pakiranja Valdoxan 25 mg filmsko obložene tablete so podolgovate, oranžnorumene z modrim odtisom (logotip podjetja) na eni strani.
Packs contain 7, 14, 28, 42, 56, 84 or 98 tablets.
Valdoxan 25 mg filmsko obložene tablete so na voljo v koledarskih pretisnih omotih po 7, 14, 28, 42, 56, 84 ali 98 filmsko obloženih tablet.
Marketing Authorisation Holder Les Laboratoires Servier 22, rue Garnier 92200 Neuilly sur Seine - France
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 22, rue Garnier 92200 Neuilly- sur- Seine Francija
and
22 in
Anpharm Przedsiebiorstwo Farmaceutyczne S. A.
Anpharm Przedsiebiorstwo Farmaceutyczne S. A. ul.
Valtropin is a white powder in a vial and solvent in a pre-filled syringe, which is prepared as a solution for injection.
Zdravilo Valtropin je bel prašek v viali in vehikel v napolnjeni brizgi, ki se zmešata v raztopino za injiciranje.
Valtropin contains the active substance somatropin.
Valtropin vsebuje zdravilno učinkovino somatropin.
Valtropin is a ‘ biosimilar product’: this means that Valtropin is similar to a biological medicine already authorised in the EU which contains the same active substance (also known as the ‘ reference medicine’).
Zdravilo Valtropin je “ biogenerično zdravilo ”: to pomeni, da je podobno biološkim zdravilom, ki so že odobrena v Evropski uniji in vsebujejo enako zdravilno učinkovino (t. i. » referenčna zdravila «).
Valtropin has been compared to and matches the reference medicine (Humatrope) in terms of quality (how it is made), safety (for example the side effects that can occur when receiving treatment are similar), and effectiveness.
Zdravilo Valtropin so primerjali z referenčnimi zdravili (Humatrope) in sicer z vidika kakovosti (načina izdelave), varnosti (npr. podobnih neželenih stranskih učinkov zdravljenja) in učinkovitosti.
Valtropin is used to treat adults in the following situation: • adult patients with pronounced growth hormone deficiency (this can have started in adulthood or childhood, and needs to be confirmed by testing before treatment) (replacement therapy).
Valtorpin se uporablja za zdravljenje otrok v naslednjih primerih: • otrok, z motnjami v rasti zaradi pomanjkanja rastnega hormona (nadomestna terapija), • otrok, ki so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene predvsem dekleta), ki ga je potrdila kromosomska analiza (DNA analiza), • otrok pred puberteto z zastojem v rasti zaradi dolgotrajne bolezni ledvic (kronično ledvično obolenje), Valtropin se uporablja za zdravljenje odraslih v naslednjih primerih: • odraslih bolnikov z dokazanim pomanjkanjem rastnega hormona (pričetek tega obolenja je možen v odrasli dobi ali v otroštvu, mora pa biti potrjeno s testi pred pričetkom zdravljenja) (nadomestna terapija).
Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Zdravljenje z Valtropinom mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami rasti.
Valtropin is given by subcutaneous injection (under the skin), once a day.
Valtropin se daje enkrat dnevno s subkutano injekcijo (pod kožo).
The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
Bolnik ali negovalec lahko zdravilo Valtropin vbrizgata sama pod pogojem, da ju medicinska sestra ali zdravnik za to ustrezno usposobita.
The doctor calculates the dose for each patient individually depending on the body weight and condition, and it may need to be adjusted over time, depending on change in body weight and response.
Mesto injiciranja mora biti vedno drugačno, da se na ta način izognemo kožnim spremembam (lipoatrofiji).
The site of injection must be varied to avoid changes to the skin (lipo-atrophy).
Vehikel (topilo), ki je vsebovan v zdravilu Valtropin, vsebuje metakresol.
The solvent supplied with Valtropin contains metacresol; patients who are allergic (hypersensitive) to metacresol should prepare the solution using water for injections.
Bolniki, ki so alergični na (preobčutljivi za) metakresol, morajo pripraviti raztopino s pomočjo vode za injekcije.
(44-20) 74 18 86 13 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does Valtropin work?
(44- 20) 74 18 86 13 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Valtropin deluje?
Growth hormone is a substance secreted by the pituitary gland (a gland located at the base of the brain).
Rastni hormon je snov, ki jo izloča žleza hipofiza (žleza, ki se nahaja na možganskem dnu).
The active ingredient in Valtropin, somatropin, is identical to the human growth hormone.
Zdravilna učinkovina zdravila Valtropin, somatropin, je identična človeškemu rastnemu hormonu.
It is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce it.
Proizvaja se po metodi, imenovani “ tehnologija rekombinantne DNA ”: hormon tvori kvasovka, ki je prejela gen (DNA), ki ji omogoča tvorbo hormona.
Valtropin was studied to show that it is comparable with the reference medicine, Humatrope.
Zdravilo Valtropin so preučevali, da bi dokazali, da je podobno referenčnemu zdravilu Humatrope.
The study lasted 12 months, and measured the children ’ s height at the beginning and the end of the study, and the speed of growth during the study.
V raziskavi, ki je trajala 12 mesecev, so merili višino otrok na začetku in koncu raziskave ter hitrost rasti med samo raziskavo.
What benefit has Valtropin shown during the studies?
Kakšne koristi je zdravilo Valtropin izkazalo med raziskavami?
After 12 months, treatment with Valtropin and Humatrope gave similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Po 12 mesecih je zdravljenje z zdravilom Valtropin in zdravilom Humatrop izkazalo podobna povečanja telesne višine in hitrosti rasti (hitrost +11, 4 in +10, 5 cm na leto).
The effectiveness of Valtropin has been shown to be equivalent to that of Humatrope.
Pokazano je bilo, da je učinkovitost zdravila Valtropin enakovredna učinkovitosti zdravila Humatrope.
The side effects seen with Valtropin were similar in type and severity as those seen with the reference medicine Humatrope.
Neželeni stranski učinki, ki so bili opaženi pri uporabi zdravila Valtropin, so bili tako po vrsti kot resnosti podobni učinkom, opaženim pri uporabi referenčnega zdravila Humatrope.
The most common side effects (seen in between 1 patient and 10 patients per 100) are: in children, mild oedema (accumulation of fluid); transient local skin reactions, low thyroid hormone levels; in adults, headache, oedema, numbness, tingling, joint pain and disorders and muscle pain.
Najpogostejši neželeni učinki (opaženi pri 1 do 10 izmed 100 bolnikov) so: pri otrocih blag edem (kopičenje tekočine), prehodne lokalne kožne reakcije, nizke ravni tiroidnega hormona; pri odraslih glavobol, edemi, odrevenelost, mravljinčenje, bolečine v sklepih in mišicah.
In addition, as with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Valtropin).
Poleg tega se lahko pri nekaterih bolnikih, kot pri vseh zdravilih, ki vsebujejo beljakovino, pojavijo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Valtropin).
For the full list of all side effects reported with Valtropin, see the Package Leaflet.
Celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Valtropin, najdete v Navodilih za uporabo.
Valtropin should not be used when the patient suffers from an active tumour, or a life-threatening illness.
Zdravila Valtropin ne smejo uporabljati bolniki, ki imajo aktiven tumor ali smrtno nevarno bolezen.
Valtropin should not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Zdravila Valtropin se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami (stanjem večjih kosti po končani rasti).
For the full list of restrictions, see the Package Leaflet.
Celovit seznam omejitev lahko najdete v Navodilih za uporabo.
Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be adjusted or started.
Med zdravljenjem je treba nadzorovati ravni sladkorja v krvi, včasih pa utegne biti potrebno prilagoditi ali uvesti zdravljenje z insulinom.
The Committee for Medicinal Products for Human Use (CHMP) considered that, in accordance with European Union requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Valtropin podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Humatrop.
Therefore, the CHMP’ s view was that, as for Humatrope, the benefit outweighs the identified risks.
Zaradi tega je CHMP menil, da so koristi zdravila Valtropin, tako kot pri zdravilu Humatrop, večje od z njim povezanih tveganj.
Which measures are being taken to ensure the safe use of Valtropin?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Valtropin?
The measures taken to ensure the safe use of Valtropin are linked to the reasons why the medicine is used.
Ukrepi, sprejeti za zagotovitev varne uporabe zdravila Valtropin, so povezani z razlogi za uporabo zdravila.
The company that makes Valtropin has planned to study in more detail the side effects of the medicine (possibility of developing diabetes, decreased thyroid activity, and any effects of the development of antibodies).
Podjetje, ki proizvaja zdravilo Valtropin načrtuje podrobnejšo raziskavo stranskih učinkov zdravila (možnost razvoja sladkorne bolezni, zmanjšana aktivnost ščitnice in vpliv pojava protiteles na učinkovitost zdravila).
Other information about Valtropin:
Druge informacije o zdravilu Valtropin:
The full EPAR for Valtropin is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Valtropin je na voljo tukaj.
Powder and solvent for solution for injection (multi-use)
Prašek in vehikel za
powder: vial (glass); solvent: pre-filled syringe (glass)
Prašek: viala (steklo)
5 mg; solvent:
5 mg
1 vial + 1 pre- filled syringe
1 viala + 1 napolnjena
Valtropin 5 mg/ 1.5 ml powder and solvent for solution for injection
Valtropin 5 mg/ 1, 5 ml prašek in vehikel za raztopino za injiciranje
One vial of powder contains 5 mg somatropin (corresponding to 15 IU).
Ena viala praška vsebuje 5 mg somatropina (kar ustreza 15 i. e.).
After reconstitution with 1.5 ml solvent, 1 ml contains: somatropin* 3.33 mg (corresponding to 10 IU) * produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
3, 33 mg somatropina * (kar ustreza 10 i. e.). * Izdelanega v celicah Saccharomyces cerevisiae z metodo rekombinantne DNA.
1.5 ml of solvent contains 4.5 mg metacresol.
1, 5 ml vehikla vsebuje 4, 5 mg metakrezola.
After reconstitution with the solvent provided Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/ kg.
Po rekonstituciji s priloženim vehiklom ima zdravilo Valtropin pH približno 7, 5, njegova osmolarnost pa je približno 320 mOsm/ kg.
- Long-term treatment of children with growth failure due to an inadequate secretion of normal
- Dolgoročno zdravljenje otrok z zaostankom v rasti zaradi nezadostnega izločanja normalnega
endogenous growth hormone.
endogenega rastnega hormona.
- Treatment of short stature in children with Turner syndrome, confirmed by chromosome
- Zdravljenje nižje rasti pri otrocih s Turnerjevim sindromom, potrjenim s kromosomsko analizo.
- Replacement therapy in adults with pronounced growth hormone deficiency of either childhood-
- Nadomestno zdravljenje pri odraslih z izrazitim pomanjkanjem rastnega hormona, ki se začne v
or adult-onset aetiology.
otroštvu ali odrasli dobi.
Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin.
Bolniki s hudim pomanjkanjem rastnega hormona v odrasli dobi so opredeljeni kot bolniki z znano patologijo osi hipotalamus– hipofiza in z vsaj enim dodatno znanim pomanjkanjem hipofiznega hormona, ki ni prolaktin.
In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test.
Pri bolnikih z izoliranim pomanjkanjem rastnega hormona od otroštva dalje (brez dokazov bolezni osi hipotalamus– hipofiza ali obsevanja glave) je treba priporočiti dva dinamična testa, razen pri tistih z nizkimi koncentracijami insulinu podobnega rastnega dejavnika 1 (IGF- 1, Insulin- Like Growth Factor- 1) (< 2 standardna odklona (SDS, Standard Deviation Score)), pri katerih zadošča en test.
Therapy with Valtropin should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency.
Zdravljenje z zdravilom Valtropin morajo začeti in spremljati zdravniki, ki imajo ustrezne izkušnje pri diagnosticiranju in zdravljenju bolnikov s terapevtskimi indikacijami za uporabo.
2 The dosage and administration schedule should be individualised for each patient.
2 Odmerjanje in urnik dajanja je treba prilagoditi posameznemu bolniku.
Dosage in paediatric patients
Odmerjanje pri pediatričnih bolnikih
Growth hormone deficiency in children The recommended dosage is 0.025 - 0.035 mg/ kg body weight per day, given as a subcutaneous injection.
Pomanjkanje rastnega hormona pri otrocih Priporočeno odmerjanje je 0, 025 - 0, 035 mg/ kg telesne teže na dan s subkutano injekcijo.
Children with Turner syndrome The recommended dosage is 0.045 - 0.050 mg/ kg body weight per day, given as a subcutaneous injection.
Otroci s Turnerjevim sindromom Priporočeno odmerjanje je 0, 045 - 0, 050 mg/ kg telesne teže na dan s subkutano injekcijo.
Pre-pubertal children with chronic renal insufficiency The recommended dosage is 0.045 - 0.050 mg/ kg body weight per day, given as a subcutaneous injection.
Otroci pred puberteto s kronično ledvično insuficienco Priporočeno odmerjanje je 0, 045 - 0, 050 mg/ kg telesne teže na dan s subkutano injekcijo.
Growth hormone deficiency in adults The recommended starting dose is 0.15 - 0.30 mg/ day, given as a subcutaneous injection.
Pomanjkanje rastnega hormona pri odraslih Priporočeno začetno odmerek je 0, 15 - 0, 30 mg na dan s subkutano injekcijo.
This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-1 concentrations.
Ta odmerek se postopno viša glede na zahteve posameznega bolnika, ki temeljijo na kliničnem odzivu in koncentraciji IGF- 1 v serumu.
IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
Koncentracije IGF- 1 je treba vzdrževati pod zgornjo mejo za starost značilnega normalnega razpona.
The minimum effective dose should be used, and dose requirements may decline with increasing age.
Potreba po odmerku se lahko s starostjo manjša.
The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.
Tako se lahko izognemo nastanku sindroma karpalnega kanala.
For further information on reconstitution and administration see section 6.6.
4. 3 Kontraindikacije
- Hypersensitivity to the active substance or to any of the excipients (e. g. metacresol) (see
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (npr. metakrezol) (glejte
section 4.4).
poglavje 4. 4).
- Any evidence of activity of a tumour.
- Kakršnikoli dokazi aktivnosti tumorja.
Intracranial lesions must be inactive and anti-tumour
Intrakranialne lezije morajo biti neaktivne in
therapy complete prior to the institution of growth hormone therapy.
protitumorsko zdravljenje končano še pred uvedbo zdravljenja z rastnim hormonom.
Valtropin should be discontinued if there is evidence of tumour growth.
Če obstajajo dokazi tumorske rasti, je treba zdravljenje z zdravilom Valtropin prekiniti.
- Patients with acute critical illness due to complications following open heart or abdominal
- Bolniki z akutno kritično boleznijo zaradi zapletov po operaciji na odprtem srcu ali operaciji