natgillin/translations-raw huggingface dataset:
Some signs of enlarged tonsils include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear.
Nekateri znaki povečanja tonzil so: smrčanje, težave pri dihanju ali požiranju, apneja v spanju (začasno prenehanje dihanja med spanjem) ali tekočina v srednjem ušesu ter tudi infekcije ušesa.
Call the doctor should these symptoms bother you/your child.
Če se ti simptomi pojavijo pri vas/ vašem otroku, se posvetujte z zdravnikom.
An infection of the tonsils has also been observed.
Opažena je bila tudi okužba tonzil.
The doctor should regularly examine your/your child’s tonsils.
Zdravnik mora stanje tonzil redno nadzirati.
Swelling inside the nose, enlarged thymus and lymph nodes have been seen with INCRELEX treatment.
Pri zdravljenju z zdravilom INCRELEX so bile opažene tudi otekline v nosu, povečan timus in limfne žleze.
Hypoacusis (hearing loss) Tell the doctor if you/your child develop hearing problems.
Če se pri vas/ vašem otroku pojavijo težave s sluhom, obvestite zdravnika.
The common side effects (likely to occur in fewer than 1 out of 10 patients) which occurred in clinical trials are listed below.
Pogosti neželeni učinki (v povprečju se pojavijo pri manj kot 1 izmed 10 bolnikov), ki so se pojavili pri kliničnih preskusih, so navedeni spodaj.
Heart abnormalities:
Nepravilnosti srca:
In some patients treated with INCRELEX, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle.
Pri nekaterih bolnikih, zdravljenih z zdravilom INCRELEX, je pregled srca z ultrazvokom (ehokardiogram) razkril povečanje srčne mišice.
Your doctor may perform an echocardiogram before, during and after INCRELEX treatment.
Vaš zdravnik lahko ehokardiogram izvede pred, med in po zdravljenju z zdravilom INCRELEX.
Also, a racing pulse and heart valve abnormalities have been reported with INCRELEX treatment.
Pri zdravljenju z zdravilom INCRELEX sta bila opažena tudi povečanje srčnega utripa in nepravilnosti zaklopke.
Intracranial hypertension (increased pressure in the brain):
Intrakranialna hipertenzija (povišan tlak v možganih):
INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain.
Zdravilo INCRELEX lahko, tako kot rastni hormon, povzroči prehodno zvišanje tlaka v glavi.
The symptoms of intracranial hypertension can include headache and nausea with vomiting.
Simptomi intrakranialne hipertenzije lahko vključujejo glavobol in siljenje na bruhanje z bruhanjem.
Tell the doctor if you/your child has headache with vomiting.
Če se pri vas/ vašem otroku pojavi glavobol z bruhanjem, to povejte zdravniku.
Vision disturbances have also been reported.
Opažene so bile tudi motnje vida.
Slipped capital femoral epiphysis:
Zdrs epifize glavice stegnenice:
This is a situation where the top of the upper leg (femur) slips apart.
To je stanje, ko vrh stegnenice zdrsne narazen.
Get medical attention for you/your child immediately if you/your child develops a limp or has hip or knee pain.
Če začnete/ vaš otrok začne šepati ali začutite/ začuti bolečino v kolku ali kolenu, poiščite zdravniško pomoč.
Worsened scoliosis (caused by rapid growth):
Poslabšanje skolioze (zaradi hitre rasti):
If you/your child has scoliosis, you/your child will need to be checked often for an increase in the curve of the spine.
Če imate/ ima vaš otrok skoliozo, bo treba pogosto preverjati morebitno preveliko ukrivljenost hrbtenice.
Pain and stiffness in muscles or joints, as well as jaw malformations, have also been seen with INCRELEX treatment.
Pri zdravljenju z zdravilom INCRELEX so bile opažene tudi bolečine in otrdelost mišic ali sklepov ter nepravilnosti čeljusti.
Infections of the mouth, throat and the upper airways have been observed in children with Increlex treatment.
Pri zdravljenju otrok z zdravilom INCRELEX so bile opažene okužbe ust, grla in zgornjih dihal.
Such infections may be associated with fever.
Tovrstne okužbe so lahko povezane z vročino.
27 Kidney disorders:
27 Bolezni ledvic:
Kidney stones have been reported, as well as associated pain and kidney swelling.
Opaženi so bili ledvični kamni ter z njimi povezane bolečine ter otekanje ledvic.
Reproductive system:
Reproduktivni sistem:
Breast enlargement, as well as cysts in the ovaries, have been observed.
Opaženo je bilo povečanje dojk in ciste na jajčnikih.
Digestive system:
Prebavni sistem:
Stomach pain, difficulties swallowing, retching and vomiting have occurred with INCRELEX treatment.
Pri zdravljenju z zdravilom INCRELEX so bile opažene bolečine v trebušnem predelu, težave s požiranjem, spahovanje in bruhanje.
Weight gain has also been reported, as have increases in blood fat and in liver enzyme values.
Opaženo je bilo tudi povečanje telesne mase ter zvišana raven maščobe v krvi in vrednosti jetrnih encimov.
Skin and hair changes:
Spremembe na koži in laseh:
Skin thickening, moles, skin tags, and abnormal hair texture have been seen with INCRELEX treatment.
Pri zdravljenju z zdravilom INCRELEX so bili opaženi debeljenje kože, kožna znamenja, bradavice in nenormalna tekstura las.
Other reported adverse events include lack of energy, depression, nervousness, disorientation, chest discomfort, dizziness, trembling and restless legs.
Ostali opaženi neželeni učinki vključujejo pomanjkanje energije, depresijo, živčnost, zmedenost, neugodje v prsnem košu, omotičnost, tresenje in nemirne noge.
HOW TO STORE INCRELEX
SHRANJEVANJE ZDRAVILA INCRELEX
Do not use INCRELEX after the expiry date which is stated on the label after EXP.
Zdravila INCRELEX ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
What INCRELEX contains
Kaj vsebuje zdravilo INCRELEX
The active substance is mecasermin.
Zdravilna učinkovina je mekasermin.
The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate, and water for injections.
Pomožne snovi so: benzilalkohol, natrijev klorid, polisorbat 20, koncentrirana ocetna kislina (ledocet), natrijev acetat in voda za injekcije.
INCRELEX is a clear and colourless solution for injection supplied in a glass vial closed with a stopper and a seal.
Na voljo je v stekleni viali, ki je zaprta z zamaškom in zapečatena.
INCRELEX is supplied as a pack containing one glass vial.
Zdravilo INCRELEX je na voljo v škatli z eno stekleno vialo.
28 Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Imetnik dovoljenja za promet z zdravilom in izdelovalec
Tercica Europe Limited Riverside One Sir John Rogerson’s Quay Dublin 2 Republic of Ireland
Tercica Europe Limited Riverside One
Slovenija Pharmaswiss d.o.o Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 1 236 47 00
Dolenjska cesta 242c SI- 1000 Ljubljana Tel: + 386 1 236 47 00
France Ipsen Pharma 65 quai Georges Gorse F-92100 Boulogne-Billancourt Tel: +33 - 1 - 58 33 50 00
France Ipsen Pharma 65 quai Georges Gorse F- 92199 Boulogne- Billancourt Tel: +33 - 1 - 58 33 50 00
Slovenská republika Liek s.r.o.
Liek s. r. o.
This medicine has been authorised under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “ izjemnih okoliščinah ”.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ There are also links to other websites about rare diseases and treatments.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
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30 INSTRUCTIONS FOR USE
30 NAVODILA ZA UPORABO
INCRELEX should be administered using sterile disposable syringes and injection needles.
Pri injiciranju zdravila INCRELEX morate uporabljati sterilne injekcijske brizge in igle za enkratno uporabo.
Preparing the Dose:
Priprava odmerka:
Wash your hands before getting INCRELEX ready for your/your child’s injection.
Preden začnete s pripravo zdravila INCRELEX za injiciranje za vas/ vašega otroka, si umijte roke.
Throw them away properly.
Po uporabi ju ustrezno zavrzite.
Do not use after the expiry date or if it is cloudy or if you see particles.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti in če je raztopina motna ali vsebuje delce.
Wipe top with alcohol
Vrh obrišite z alkoholom
Inject air into vial
V vialo iztisnite zrak
Prepare for extraction
Priprava na odvzem odmerka iz viale
Tip in liquid
Konica v tekočini
Extract correct dose
Izvlecite ustrezen odmerek
Figure 6:
Slika 6:
Remove air bubbles and refill syringe
Odstranite zračne mehurčke in znova napolnite brizgo
Remove the needle from the vial.
Iglo izvlecite iz viale.
Ready to inject
Brizga pripravljena za injiciranje
Injecting the Dose:
Zdravilo INCRELEX injicirajte, kot vam je pokazal zdravnik.
Inject INCRELEX as instructed by the doctor.
1.
Buttock
Zadnjica
Use alcohol or soap and water to clean the skin where you are going to inject you/your child.
Mesto injiciranja pred injiciranjem očistite z alkoholom ali milom in vodo.
Lightly pinch the skin and inject as instructed
Kožo rahlo stisnite v gubo in injicirajte kot vam je pokazal zdravnik
Pull the needle straight out and gently press on the spot where you injected you/your child with gauze or a cotton ball for a few seconds.
Iglo izvlecite naravnost in na mesto injiciranja za nekaj sekund rahlo pritisnite z gazo ali kosom vate.
Press (don’t rub) with gauze or cotton
Pritisnite (ne drgnite) z gazo ali vato
Such containers should be sealed and disposed of properly.
Takšne posode morate dobro zapreti in nato ustrezno zavreči.
Pharmaceutical Form
Farmacevska oblika
Kit for implant
peri- osalna
peri-osseous use
Komplet za implantacijo
1 vial + 1 vial + 1 matrix + 2 syringes + 2 needles
1 viala + 1 viala + 1 matriks + 2 brizgi + 2 igli
What is InductOs?
Kaj je zdravilo InductOs?
InductOs is a kit for implant.
Zdravilo InductOs je komplet za vsaditev.
The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Komplet tvorijo prašek, ki vsebuje zdravilno učinkovino dibotermin alfa, vehikel in matriks (kolagenska gobica).
What is InductOs used for?
Za kaj se zdravilo InductOs uporablja?
InductOs is used to help new bone develop.
Zdravilo InductOs se uporablja za spodbujanje razvoja nove kosti.
It can be used in the following situations: • lower back spine fusion surgery.
Uporablja se lahko v naslednjih primerih: • pri operacijah za fuzijo (spajanje) v ledvenem delu hrbtenice.
This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Gre za kirurški poseg, ki se uporablja za lajšanje bolečine v hrbtu zaradi poškodovane medvretenčne ploščice, pri katerem se odstrani medvretenčna ploščica med dvema vretencema (kostema hrbtenice), vretenci pa se nato spojita.
InductOs is used together with a special metal cage that corrects the position of the spine.
Zdravilo InductOs se uporablja skupaj s posebnim kovinskim vstavkom, ki popravi položaj hrbtenice.
In this type of surgery, InductOs can be used instead of a bone graft (bone that is taken from another part of the same patient’ s body or from a bone donor) in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation. • surgery to heal fractures (breaks) of the tibia (shin bone).
Pri tej vrsti operacij se lahko zdravilo InductOs uporablja namesto kostnega presadka (kosti, odvzete iz drugega dela telesa istega bolnika ali iz kosti darovalca) pri odraslih, ki so bili vsaj 6 mesecev zdravljeni zaradi bolečin v hrbtu, katerih izvor je poškodovana medvretenčna ploščica, vendar niso bili operirani; • pri operacijah za zdravljenje zlomov golenice.
InductOs is used in addition to standard treatment and care.
Zdravilo InductOs se uporablja kot dodatek k standardnemu zdravljenju in oskrbi.
It is only used when the nail to fix the bone does not need ‘ reaming’ (drilling to make room for nail placement).
Uporablja se samo, kadar vijak za pritrditev kosti ne potrebuje vrtanja (luknjanja za pridobitev prostora za namestitev vijaka).
How is InductOs used?
Kako se zdravilo InductOs uporablja?
InductOs should be used by a qualified surgeon.
Zdravilo InductOs lahko uporablja le ustrezno usposobljen kirurg.
InductOs is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Zdravilo InductOs se pred uporabo pripravi v obliki raztopine ter nanese na matriks, nakar je treba počakati najmanj 15 minut (vendar ne več kot dve uri).
The matrix is then cut, if needed, to the correct size before use.
Pred vsaditvijo je mogoče matriks po potrebi odrezati na ustrezno velikost.
For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with two metal cages filled with InductOs.
Pri fuziji v ledvenem delu hrbtenice se odstrani poškodovana medvretenčna ploščica med vretenci ter nadomesti z dvema kovinskima vstavkoma, napolnjenima z zdravilom InductOs.
The metal cages fix the position of the vertebrae, and InductOs encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Kovinska vstavka fiksirata položaj hrbtenice, zdravilo InductOs pa spodbudi rast kosti med vretencema, tako da se trajno spojita v pravilnem položaju.
For a fractured tibia, InductOs is placed around the broken bone to aid healing.
Pri zlomu golenice se zdravilo InductOs namesti okrog zlomljene kosti, da bi tako spodbudili celjenje.
Reproduction is authorised provided the source is acknowledged. dissolves away.
Reproduction is authorised provided the source is acknowledged Kako zdravilo InductOs deluje?
Dibotermin alfa is produced by a method known as ‘ recombinant DNA technology’: it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Učinkovina je kopija proteina, imenovanega kostni morfogenetski protein 2 (BMP- 2), ki se naravno tvori v telesu in pomaga pri tvorbi novega kostnega tkiva.
The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Dibotermin alfa se proizvaja po metodi, imenovani „ tehnologija rekombinantne DNK “: tvorijo ga celice, ki so prejele gen (DNK), s katerim lahko tvorijo dibotermin alfa.
How has InductOs been studied?
Kako je bilo zdravilo InductOs raziskano?
InductOs has been studied in 279 patients having lower back spine fusion.
Zdravilo InductOs so preučevali pri 279 bolnikih, pri katerih je bila izvedena fuzija v ledvenem delu hrbtenice.
Spinal fusion using InductOs was compared with fusion using a bone graft removed from the hip during surgery.
Fuzijo hrbtenice ob uporabi zdravila InductOs so primerjali s fuzijo ob uporabi kostnega presadka, odvzetega iz kolka med operacijo.
The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Glavno merilo učinkovitosti je bila fuzija vretenc, potrjena z rentgenskim slikanjem, ter izboljšanje z vidika bolečine in invalidnosti po poročanju bolnika, merjeno dve leti po operaciji.
InductOs has been studied in 450 patients with a fractured tibia.
Zdravilo InductOs so preučevali pri 450 bolnikih z zlomom golenice.
The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Zdravilo InductOs so primerjali s standardno oskrbo, glavno merilo učinkovitosti pa je bilo število bolnikov, ki v letu po operaciji niso potrebovali nadaljnjega zdravljenja zloma golenice (kot npr. kostnega presadka ali menjave vijaka, uporabljenega za fiksiranje kosti).
What benefit has InductOs shown during the studies?
Kakšne koristi je zdravilo InductOs izkazalo med študijami?
In spinal fusion, InductOs was as effective as bone grafts.
Pri fuziji hrbtenice je bilo zdravilo InductOs enako učinkovito kot kostni presadek.
After two years, 57% of the patients treated with InductOs (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Po dveh letih se je na zdravljenje odzvalo 57% (69 od 122) bolnikov, zdravljenih z zdravilom InductOs, v primerjavi z 59% (78 od 133) bolnikov, ki so bili zdravljeni s kostnim presadkom.
In patients with a fractured tibia, using InductOs in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Pri bolnikih z zlomom golenice je bila uporaba zdravila InductOs poleg standardne oskrbe z vidika zmanjševanja tveganja za neuspeh zdravljenja učinkovitejša od zgolj standardne oskrbe.
Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving InductOs.
46% bolnikov iz skupine s standardno oskrbo je v okviru prvega leta potrebovalo nadaljnje posege za ozdravitev zloma, medtem ko je bilo v skupini, ki je prejela tudi zdravilo InductOs, takih bolnikov 26%.
What is the risk associated with InductOs?
Kakšna tveganja so povezana z zdravilom InductOs?
When used in spinal fusion surgery, the most common side effects with InductOs (seen in more than 1 patient in 10) are accidental injury, neuralgia (nerve pain), back pain and bone disorders (such as delayed healing), but these were seen as frequently in patients receiving standard care.
Pri uporabi zdravila InductOs za fuzijo hrbtenice so bili njegovi najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) naključne poškodbe, nevralgija (bolečina živčnega izvora), bolečina v hrbtu in kostna obolenja (npr. upočasnjeno celjenje), vendar pa so bili ti učinki enako pogosti tudi pri bolnikih, ki so prejemali standardno oskrbo.
When used in tibia fracture surgery, the most common side effect with InductOs (seen in more than 1 patient in 10) is infection.
Pri uporabi pri operaciji zloma golenice je bil najpogostejši neželeni učinek zdravila InductOs (opažen pri več kot 1 bolniku od 10) okužba.
Infection is more common with InductOs than with standard care when the patient’ s bones are fixed together using reamed nails.
Okužba je pogostejša z zdravilom InductOs kot pri standardni oskrbi, ko so bolnikove kosti spojene z vijaki.
For the full list of all side effects reported with InductOs, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila InductOs, glejte navodilo za uporabo.
InductOs should not be used in people who may be hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
Zdravila InductOs ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) dibotermin alfa ali katero koli drugo sestavino zdravila.
InductOs should also not be used in the following situations: • patients who are still growing; • patients diagnosed with or being treated for cancer; • patients with an active infection at the surgery site; • patients with an inadequate blood supply at the fracture site; • treating a fracture that is related to a disease such as Paget’ s disease or cancer.
Zdravilo InductOs se prav tako ne sme uporabljati v naslednjih primerih: • pri bolnikih, ki še rastejo; • pri bolnikih, pri katerih je bil diagnosticiran rak ali se zdravijo zaradi raka; • pri bolnikih z aktivno okužbo v operativnem območju; • pri bolnikih, ki na mestu zloma nimajo ustrezne prekrvavitve; • za zdravljenje zloma, ki je povezan z boleznijo, kot je Pagetova bolezen ali rak.
Why has InductOs been approved?
Zakaj je bilo zdravilo InductOs odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that InductOs’ s benefits are greater than its risks for single-level (L4 - S1) anterior lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila InductOs za enonivojsko (L4– S1) prednjo fuzijo ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek ter za zdravljenje akutnih zlomov golenice pri odraslih kot dodatek k standardni oskrbi večje od z njim povezanih tveganj.
The Committee recommended that InductOs be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo InductOs odobri dovoljenje za promet z zdravilom.
Other information about InductOs:
2/ 3 Druge informacije o zdravilu InductOs:
The European Commission granted a marketing authorisation valid throughout the European Union for InductOs to Wyeth Europa Ltd on 9 September 2002.
Evropska komisija je dovoljenje za promet z zdravilom InductOs, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Europa Ltd dne 9. septembra 2002.
The marketing authorisation was renewed on 9 September 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 9. septembra 2007.
The full EPAR for InductOs is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo InductOs je na voljo tukaj.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
InductOs 12 mg kit for implant
InductOs 12 mg komplet za implantacijo
One vial contains 12 mg dibotermin alfa*.
Ena viala vsebuje 12 mg dibotermina alfa *.
*dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Po rekonstituciji vsebuje 1, 5 mg/ ml dibotermina alfa. * dibotermin alfa (rekombinantni humani protein za morfogenezo kosti- 2; rhBMP- 2) je človeški protein, pridobljen iz rekombinantne vrste ovarijskih celic kitajskega hrčka (CHO – » Chinese Hamster Ovary «).
Kit for implant.
Komplet za implantacijo.
The kit consists of a white powder for solution, a clear colourless solvent and a white matrix.
Komplet vsebuje bel prašek za raztopino, bister brezbarvni vehikel in bel matriks.
InductOs is indicated for single-level (L4 – S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non- operative treatment for this condition.
Zdravilo InductOs je indicirano za enonivojsko (L4 – S1) prednjo fuzijo ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek pri odraslih z degenerativno boleznijo medvretenčnih ploščic, ki so bili zaradi te bolezni vsaj 6 mesecev konservativno zdravljeni.
See section 5.1.
Glejte poglavje 5. 1.
The directions for preparation for each kit should be followed exactly using the appropriate amount of InductOs for the intended indication.
Natančno upoštevajte navodila za pripravo vsakega kompleta in uporabite ustrezno količino zdravila InductOs za indikacijo, ki ji je zdravilo namenjeno.
InductOs is prepared immediately prior to use from a kit containing all necessary components.
Zdravilo InductOs se pripravlja neposredno pred uporabo iz kompleta, ki vsebuje vse potrebne komponente.
Once prepared, InductOs contains dibotermin alfa at a concentration of 1.5 mg/ ml (12 mg per vial).
Ko je zdravilo InductOs pripravljeno, vsebuje dibotermin alfa v koncentraciji 1, 5 mg/ ml (12 mg na vialo).
InductOs should not be used in concentrations higher than 1.5 mg/ ml (see section 4.9).
Zdravilo InductOs se ne sme uporabljati v koncentracijah, višjih od 1, 5 mg/ ml (glejte poglavje 4. 9).
There is very limited experience of the efficacy and safety of the medicinal product in the elderly (> 65 years of age).
Izkušenj glede učinkovitosti in varnosti tega zdravila pri starejših (> 65 let starosti) je malo.
2 Paediatric use is not recommended until further data become available.
Uporabe pri otrocih ne priporočamo, dokler ne bo na voljo več podatkov.
Product preparation
2 Priprava zdravila