natgillin/translations-raw huggingface dataset:
Common, may affect up to 1 in 10 people - virus infection known as Herpes simplex - skin tag (a form of harmless skin growth) - tiredness - weakness, feeling unwell - face swelling - thirst - pain, chest pain, pain at the injection site - pain in the back, arms, legs, shoulders, bones, joints - sleeplessness - decreased sensation, numbness and tingling in fingers and palm of the hand due to squeezed nerve at wrist (carpal tunnel syndrome) - dizziness, sleepiness - muscular or bone stiffness, weakness of the muscles, muscle pain, feeling of heaviness - inflammation of the tendons, joint swelling, joint inflammation - reddening of the eyes, reduced vision, vertigo (a feeling of dizziness or spinning) - increased or irregular heart rate - high blood pressure - nosebleed - nausea - increased level of bilirubin, a substance produced by the liver - inflammation of the gall bladder - acne, increased sweating, skin rash - allergic skin reactions such as redness, irritation, itching - blood in the urine - nipple pain - reduced function of the adrenal gland (which could show as tiredness) - reduced function of the thyroid gland - increased fat levels in the blood - weight gain - development of substances (antibodies) in the blood that bind to growth hormone - changes in blood test results such as a change in the number of white blood cells or increased levels of insulin, sugar, sodium or certain fatty substances in the blood - changes in liver test results - a type of benign brain tumour called craniopharyngioma
- visok krvni tlak - krvavitev iz nosu - slabost - zvišana raven bilirubina, snovi, ki nastaja v jetrih - vnetje žolčnika - akne, povečano potenje, kožni izpuščaj - alergijske kožne reakcije, kot so rdečina, draženje, srbenje - kri v urinu - boleče prsne bradavice - zmanjšano delovanje nadledvične žleze (kar se lahko kaže v obliki utrujenosti) - zmanjšano delovanje žleze ščitnice - zvišane ravni maščob v krvi - pridobivanje telesne mase - razvoj snovi (protiteles) v krvi, ki vežejo rastni hormon - spremenjeni rezultati krvnih preiskav, kot so spremenjeno število belih krvnih celic ali zvišane ravni insulina, sladkorja, natrija ali nekaterih maščobnih snovi v krvi - spremenjeni rezultati jetrnih preiskav - vrsta benignega možganskega tumorja, imenovanega kraniofaringiom
What Somatropin Biopartners looks like and contents of the pack
Izgled zdravila Somatropin Biopartners in vsebina pakiranja
To avoid this, always change the injection site between injections.
Da to preprečite, vsakič izberite drugo mesto injiciranja.
Solvent: medium chain triglycerides.
Vehikel: srednjevreižni trigliceridi
Common: Decreased or increased white blood cell count, increased glycosylated haemoglobin, decreased haemoglobin
Bolezni krvi in limfatičnega sistema pogosti: zmanjšano ali povečano število belih krvnih celic, povečana raven glikoziliranega hemoglobina, zmanjšana raven hemoglobina
Solvent: Medium chain triglycerides.
Vehikel: srednjeverižni trigliceridi
Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth; - if you are ill due to a serious heart or stomach operation;
Vaš zdravnik bo zdravljenje s tem zdravilom ustavil, če bodo obstajali dokazi rakave rasti.
Psychiatric disorders Common: Insomnia
Psihiatrične motnje pogosti: nespečnost
If you forget to use Somatropin Biopartners
Če ste pozabili vzeti zdravilo Somatropin Biopartners
Any child with the onset of a limp during growth hormone therapy should be evaluated.
Vsakega otroka, pri katerem se med zdravljenjem s somatropinom pojavi šepanje, je treba klinično pregledati.
Hepatobiliary disorders Common: Hyperbilirubinaemia, cholecystitis, liver test abnormal
Bolezni jeter, žolčnika in žolčevodov pogosti: hiperbilirubinemija, holecistitis, nenormalni rezultati jetrnih testov
Repeated adjustments in dose may be required, dependent on patients' IGF-I response.
Glede na bolnikov odziv IGF-I bo morda treba odmerek ponovno prilagoditi.
Withdrawing the suspension
Izvlek suspenzije
Use a 1 mL graduated syringe with a 19G or wider needle for withdrawing the solvent from its vial.
Uporabite 1 ml graduirano injekcijsko brizgo z iglo velikosti 19 G ali večjo, da izvlečete vehikel iz viale.
For other doses vials with 4 or 7 mg somatropin are available.
Za druge odmerke so na voljo viale s 4 ali 7 mg somatropina.
Common: Impaired fasting glucose, hyperlipidaemia, increased blood insulin, increased blood cholesterol, decreased blood sodium, increased blood triglycerides, increased blood glucose, increased or decreased HDL, increased LDL
Presnovne in prehranske motnje zelo pogosti: blaga hiperglikemija* pogosti: vpliv na glukozo na tešče, hiperlipidemija, povečanje ravni insulina v krvi, povečanje ravni holesterola v krvi, zmanjšanje ravni natrija v krvi, povečanje ravni trigliceridov v krvi, povečanje ravni glukoze v krvi, povečanje ali zmanjšanje ravni HDL, povečanje ravni LDL neznana: odpornost na insulin*
Ask your doctor for advice before stopping treatment.
Preden prenehate z zdravljenjem, se posvetujte s svojim zdravnikom.
For other doses vials with 2 or 7 mg somatropin are available.
Za druge odmerke so na voljo viale z 2 ali 7 mg somatropina.
Information about self-injection of Somatropin Biopartners
Informacije o samoinjiciranju zdravila Somatropin Biopartners
Non-clinical data revealed no specific hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
For other doses vials with 2 or 4 mg somatropin are available.
Za druge odmerke so na voljo viale z 2 ali 4 mg somatropina.
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala dostavi 2 mg somatropina* (kar ustreza 6 i.e.).
Apply gentle pressure by pushing the plunger up, until all bubbles are removed from the syringe and needle.
Na bat nežno pritiskajte, dokler ne odstranite vseh mehurčkov iz injekcijske brizge in igle.
Somatropin Biopartners is a powder and solvent for prolonged-release suspension for injection.
Zdravilo Somatropin Biopartners je prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
Somatropin Biopartners 20 mg should be reconstituted with 1.2 mL solvent.
Zdravilo Somatropin Biopartners 20 mg je treba rekonstituirati z 1,2 ml vehikla.
The 10-mg vial contains an overfill of somatropin powder to allow the withdrawal of up to 10 mg (0.5 mL suspension) of somatropin when reconstituted.
10-mg viala vsebuje presežek praška somatropina, kar omogoči odvzem do 10 mg (0,5 ml suspenzije) rekonstituiranega somatropina.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko
Powder: sodium hyaluronate, egg phospholipids, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous.
Prašek: natrijev hialuronat, jajčni fosfolipidi, brezvodni natrijev dihidrogenfosfat, brezvodni dinatrijev fosfat.
1 vial of powder and 1 vial of solvent.
1 viala praška in 1 viala vehikla.
After reconstitution, 1 mL of suspension contains 20 mg (20 mg/mL).
Po rekonstituciji 1 ml suspenzije vsebuje 20 mg (20 mg/ml)
Pack size of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Velikost pakiranja 1 viala s praškom in 1 viala z vehiklom ter 4 viale s praškom in 4 viale z
For children heavier than 20 kg, Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection is available.
Za otroke s telesno maso več kot 20 kg je na voljo zdravilo Somatropin Biopartners 20 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
Gastrointestinal disorders Common: vomitting (1.1%), abdominal pain (1.1%)
Bolezni prebavil pogosti: bruhanje (1,1 %), bolečine v trebuhu (1,1 %)
This medicine is used to treat failure to grow normally (growth deficiency) in children and adolescents aged 2 to 18 years with insufficient secretion of growth hormone.
To zdravilo se uporablja pri otrocih in mladostnikih, starih od 2 do 8 let, ki zaradi nezadostnega izločanja ratsnega hormona ne rastejo ustrezno (pomanjkanje rastnega hormona).
This is because the doctor will stop the treatment should a tumour occur.
Če se pojavi tumor, bo zdravnik zdravljenje ustavil.
Somatropin Biopartners is not recommended during pregnancy.
Zdravila Somatropin Biopartners ne uporabljajte pri nosečnicah.
Reproductive system and breast disorders Common: Nipple pain Uncommon: Gynaecomastia*
Motnje reprodukcije in dojk pogosti: boleče bradavice občasni:ginekomastija*
Any suspension remaining after the injection should
Zavrzite suspenzijo, ki bi morebiti ostala po injiciranju.
For children up to 20 kg Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection is available.
Za otroke s telesno maso do 20 kg je na voljo zdravilo Somatropin Biopartners 10 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
One powder vial delivers 7 mg of somatropin (21 IU).
Ena viala s praškom dostavi 7 mg somatropina (21 i.e.).
4 vials of powder and 4 vials of solvent.
4 viale praška in 4 viale vehikla.
To remove any bubbles, gently tap the syringe.
Da odstranite mehurčke, nežno potrkajte po injekcijski brizgi.
- Somatropin Biopartners 7 mg: One vial of powder delivers 7 mg somatropin, corresponding to 21 IU.
- Somatropin Biopartners 7 mg: Ena viala s praškom dostavi 7 mg somatropina, kar ustreza 21 i.e..
After preparation, 1 mL of suspension contains 20 mg somatropin (20 mg/mL).
Po rekonstituciji 1 ml suspenzije vsebuje 20 mg somatropina (20 mg/ml).
No clinical studies have been conducted with Somatropin Biopartners in breast-feeding women.
Kliničnih študij z zdravilom Somatropin Biopartners niso opravili.
After reconstitution, 0.5 mL of suspension contains 10 mg (20 mg/mL).
Po rekonstituciji 0,5 ml suspenzije vsebuje 10 mg (20 mg/ml)
One powder vial delivers 20 mg of somatropin (60 IU).
Ena viala s praškom dostavi 20 mg somatropina (60 i.e.).
There is no relevant use of Somatropin Biopartners 7 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Zdravilo Somatropin Biopartners 7 mg ni primerno za uporabo pri pediatrični populaciji za indikacijo dolgoročnega zdravljenja zaostanka v rasti zaradi nezadostnega izločanja endogenega rastnega hormona.
Common: Haematuria, increased blood uric acid, increased blood creatinine Reproductive system and breast disorders
Bolezni sečil pogosti: hematurija, povečana raven sečne kisline v krvi, povečana raven kreatinina v krvi
There is no relevant use of Somatropin Biopartners 4 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Zdravilo Somatropin Biopartners 4 mg ni primerno za uporabo pri pediatrični populaciji za indikacijo dolgoročnega zdravljenja zaostanka v rasti zaradi nezadostnega izločanja endogenega rastnega hormona.
After reconstitution, 0.7 mL of suspension contains 7 mg (10 mg/mL).
Po rekonstituciji 0,7 ml suspenzije vsebuje 7 mg (10 mg/ml).
What Somatropin Biopartners contains
Kaj vsebuje zdravilo Somatropin Biopartners
One powder vial delivers 10 mg of somatropin (30 IU).
Ena viala s praškom dostavi 10 mg somatropina (30 i.e.).
There is no relevant use of Somatropin Biopartners 2 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Zdravilo Somatropin Biopartners 2 mg ni primerno za uporabo pri pediatrični populaciji za indikacijo dolgoročnega zdravljenja zaostanka v rasti zaradi nezadostnega izločanja endogenega rastnega hormona.
Excipients
Protitelesa
One powder vial delivers 2 mg of somatropin (6 IU).
Ena viala s praškom dostavi 2 mg somatropina (6 i.e.).
- Somatropin Biopartners 2 mg: One vial of powder delivers 2 mg somatropin, corresponding to 6 IU.
- Somatropin Biopartners 2 mg: Ena viala s praškom dostavi 2 mg somatropina, kar ustreza 6 i.e..
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/006 1 vial of powder and 1 vial of solvent EU/1/13/849/007 4 vials of powder and 4 vials of solvent
EU/1/13/849/006 1 viala s praškom in 1 viala z vehiklom EU/1/13/849/007 4 viale s praškom in 4 viale z vehiklom
The syringe should be held upright and gentle pressure applied to the plunger until a small drop of suspension appears at the end of the needle.
Injekcijsko brizgo držite navpik in z nežnim pritiskanjem na bat iztisnite majhno kapljico na koncu igle.
- Somatropin Biopartners 4 mg: One vial of powder delivers 4 mg somatropin, corresponding to 12 IU.
- Somatropin Biopartners 4 mg: Ena viala s praškom dostavi 4 mg somatropina, kar ustreza 12 i.e..
After reconstitution, 0.4 mL of suspension contains 4 mg (10 mg/mL).
Po rekonstituciji 0,4 ml suspenzije vsebuje 4 mg (10 g/ml).
After reconstitution, 0.2 mL of suspension contains 2 mg (10 mg/mL).
Po rekonstituciji 0,2 ml suspenzije vsebuje 2 mg (10 g/ml).
After preparation, 0.5 mL of suspension contains 10 mg somatropin (20 mg/mL).
Po rekonstituciji 0,5 ml suspenzije vsebuje 10 mg somatropina (20 mg/ml).
- Somatropin Biopartners 10 mg: One vial of powder delivers 10 mg somatropin, corresponding to 30 IU.
- Somatropin Biopartners 10 mg: Ena viala s praškom dostavi 10 mg somatropina, kar ustreza 30 i.e..
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/004 1 vial of powder and 1 vial of solvent EU/1/13/849/005 4 vials of powder and 4 vials of solvent
EU/1/13/849/004 1 viala s praškom in 1 viala z vehiklom EU/1/13/849/005 4 viale s praškom in 4 viale z vehiklom
Powder and solvent for prolonged-release suspension for injection 1 vial of 10 mg powder
Vehikel: srednjeverižni trigliceridi prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem 1 viala z 10 mg praška
After preparation, 0.7 mL of suspension contains 7 mg somatropin (10 mg/mL).
Po rekonstituciji 0,7 ml suspenzije vsebuje 7 mg somatropina (10 mg/ml).
Apply gentle pressure to the plunger to get rid of the bubbles.
Na bat nežno pritiskajte, da mehurčke iztisnete.
The vial contains an overfill of somatropin powder to allow the withdrawal of up to 4 mg (0.4 mL suspension) of somatropin when reconstituted.
Viala vsebuje presežek praška somatropina, kar omogoči odvzem do 4 mg (0,4 ml suspezije) rekonstituiranega somatropina.
The vial contains an overfill of somatropin powder to allow the withdrawal of up to 7 mg (0.7 mL suspension) of somatropin when reconstituted.
Viala vsebuje presežek praška somatropina, kar omogoči odvzem do 7 mg (0,7 ml suspezije) rekonstituiranega somatropina.
The vial contains an overfill of somatropin powder to allow the withdrawal of up to 2 mg (0.2 mL suspension) of somatropin when reconstituted.
Viala vsebuje presežek praška somatropina, kar omogoči odvzem do 2 mg (0,2 ml suspezije) rekonstituiranega somatropina.
One powder vial delivers 4 mg of somatropin (12 IU).
Ena viala s praškom dostavi 4 mg somatropina (12 i.e.).
Somatropin Biopartners 4 mg should be reconstituted with 0.6 mL solvent.
Zdravilo Somatropin Biopartners 4 mg je treba rekonstituirati z 0,6 ml vehikla.
INFORMATION IN BRAILLE Somatropin Biopartners 7 mg
PODATKI V BRAILLOVI PISAVI Somatropin Biopartners 7 mg
Caution should be exercised when this medicinal product is administered to breast-feeding women.
Pri dajanju tega zdravila je potrebna previdnost.
The weekly dose of 0.5 mg of somatropin per kilogram of body weight should not be exceeded due to limited experience with higher doses in children.
Zaradi omejenih izkušenj pri z dajanjem višjih odmerkov otrokom ne presezite tedenskega odmerka 0,5 mg somatropina na kilogram telesne mase.
After reconstitution, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Po rekonstituciji 0,2 ml suspenzije vsebuje 2 mg somatropina (10 mg/ml).
After preparation, 0.4 mL of suspension contains 4 mg somatropin (10 mg/mL).
Po rekonstituciji 0,4 ml suspenzije vsebuje 4 mg somatropina (10 mg/ml).
To remove small air bubbles the syringe should be tapped gently.
Da odstranite zračne mehurčke, nežno potrkajte po injekcijski brizgi.
- Somatropin Biopartners 20 mg: One vial of powder delivers 20 mg somatropin, corresponding to 60 IU.
- Somatropin Biopartners 10 mg: Ena viala s praškom dostavi 20 mg somatropina, kar ustreza 60 i.e..
- Somatropin Biopartners 20 mg: 20 mg (60 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
- Somatropin Biopartners 20 mg: 20 mg (60 i.e.) somatropina v obliki praška v stekleni viali, zaprti z gumijastim zamaškom (butil) in zeleno prekrivno zaporko (aluminij in plastika) in 1,5 ml vehikla (srednjeverižni trigliceridi) v stekleni viali z gumijastim zamaškom (butil).
Somatropin Biopartners 2 mg should be reconstituted with 0.4 mL solvent.
Zdravilo Somatropin Biopartners 2 mg je treba rekonstituirati z 0,4 ml vehikla.
It is recommended to monitor thyroid function following an overdose.
Po prevelikem odmerjanju se priporoča spremljanje delovanja ščitnice.
INFORMATION IN BRAILLE Somatropin Biopartners 4 mg
PODATKI V BRAILLOVI PISAVI Somatropin Biopartners 4 mg
Somatropin Biopartners 10 mg should be reconstituted with 0.7 mL solvent.
Zdravilo Somatropin Biopartners 10 mg je treba rekonstituirati z 0,7 ml vehikla.
Somatropin Biopartners 7 mg should be reconstituted with 0.9 mL solvent.
Zdravilo Somatropin Biopartners 7 mg je treba rekonstituirati z 0,9 ml vehikla.
Ear and labyrinth disorders Common: Vertigo
Ušesne bolezni, vključno z motnjami labirinta pogosti: vrtoglavica
- Somatropin Biopartners 2 mg: 2 mg (6 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in a glass vial with a rubber stopper (butyl).
- Somatropin Biopartners 2 mg: 2 mg (6 i.e.) somatropina v obliki praška v stekleni viali, zaprti z gumijastim zamaškom (butil) in rumeno prekrivno zaporko (aluminij in plastika) in 1,5 ml vehikla (srednjeverižni trigliceridi) v stekleni viali z gumijastim zamaškom (butil).
- Somatropin Biopartners 10 mg: 10 mg (30 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
- Somatropin Biopartners 10 mg: 10 mg (30 i.e.) somatropina v obliki praška v stekleni viali, zaprti z gumijastim zamaškom (butil) in svetlozeleno prekrivno zaporko (aluminij in plastika) in 1,5 ml vehikla (srednjeverižni trigliceridi) v stekleni viali z gumijastim zamaškom (butil).
Hold the fold between the thumb and the forefinger during the entire injection.
Gubo ves čas injiciranja držite s palcem in kazalcem.
INFORMATION IN BRAILLE Somatropin Biopartners 20 mg
ZUNANJA OVOJNINA SOMATROPIN BIOPARTNERS 20 MG
- Somatropin Biopartners 7 mg: 7 mg (21 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-blue flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Somatropin Biopartners 7 mg: 7 mg (21 i.e.) somatropina v obliki praška v stekleni viali, zaprti z gumijastim zamaškom (butil) in svetlomodro prekrivno zaporko (aluminij in plastika) in 1,5 ml vehikla (srednjeverižni trigliceridi) v stekleni viali z gumijastim zamaškom (butil).
Pack size: 4 vials of powder and 4 vials of solvent.
Velikost pakiranja: 4 viale s praškom in 4 viale z vehiklom.
- Somatropin Biopartners 4 mg: 4 mg (12 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
- Somatropin Biopartners 4 mg: 4 mg (12 i.e.) somatropina v obliki praška v stekleni viali, zaprti z gumijastim zamaškom (butil) in rožnato prekrivno zaporko (aluminij in plastika) in 1,5 ml vehikla (srednjeverižni trigliceridi) v stekleni viali z gumijastim zamaškom (butil) Velikost pakiranja 4 viale praška in 4 viale vehikla.
Powder and solvent for prolonged-release suspension for injection 4 vials of 7 mg powder
Vehikel: srednjeverižni trigliceridi prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem 4 viale s 7 mg praška
Each vial of powder delivers 20 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Ena viala praška dostavi 20 mg somatropina; ena viala vehikla vsebuje 1,5 ml tekočine.
NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection
IME ZDRAVILA Somatropin Biopartners 7 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
The vial should be turned upside down, with the syringe in and the tip of the needle should be placed in the solvent.
Vialo nato obrnite navzdol z vstavljeno injekcijsko brizgo, pri tem naj bo konica igle v vehiklu.
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous.
Prašek: natrijev hialuronat jajčni fosfolipidi brezvodni natrijev dihidrogenfosfat brezvodni dinatrijev fosfat
Renal/hepatic impairment
Okvarjeno delovanje ledvic/jeter
NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 4 mg powder and solvent for prolonged-release suspension for injection
IME ZDRAVILA Somatropin Biopartners 4 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Each vial of powder delivers 7 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Ena viala praška dostavi 7 mg somatropina; ena viala vehikla vsebuje 1,5 ml tekočine.
Powder and solvent for prolonged-release suspension for injection.
prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem Bel do belkast prašek.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/002 4 vials of powder and 4 vials of solvent
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/849/002 4 viale s praškom in 4 viale z vehiklom 13.
NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 2 mg powder and solvent for prolonged-release suspension for injection
IME ZDRAVILA Somatropin Biopartners 2 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/003 4 vials of powder and 4 vials of solvent
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/849/003 4 viale s praškom in 4 viale z vehiklom 13.
Powder and solvent for prolonged-release suspension for injection 4 vials of 2 mg powder
Vehikel: srednjeverižni trigliceridi prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem 4 viale z 2 mg praška
Powder and solvent for prolonged-release suspension for injection 4 vials of 4 mg powder
Vehikel: srednjeverižni trigliceridi prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem 4 viale z 4 mg praška
Egg phospholipids
PODATKI NA ZUNANJI OVOJNINI
Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection
Somatropin Biopartners 20 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection
Somatropin Biopartners 10 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Somatropin Biopartners 4 mg powder for prolonged-release suspension for injection somatropin
Somatropin Biopartners 4 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem somatropin s.c. za odrasle
Treatment should be discontinued if there is evidence of tumour
Če obstajajo znaki rasti tumorja, je treba zdravljenje prekiniti.
Testing for antibodies to somatropin may be considered in patients with otherwise unexplained lack of growth response.
Pri bolnikih, pri katerih pomanjkanja rastnega odziva ni mogoče drugače razložiti, se lahko opravi test na protitelesa na somatropin.