FrancophonIA/ELRC3.0 huggingface dataset:
English: After 6 months of weekly treatment with Somatropin Biopartners, there was a statistically significant reduction of 1.6 kg in fat mass in the Somatropin Biopartners group compared to the placebo group.
Maltese: Wara 6 xhur ta' kura ta' kull ġimgħa b'Somatropin Biopartners, kien hemm tnaqqis statistikament sinifikanti ta' 1.6 kg fil-massa ta' xaħam fil-grupp ta' Somatropin Biopartners meta mqabbel mal-grupp tal-plaċebo.
English: Store in a refrigerator (2 - 8°C).
Maltese: Aħżen fi friġġ (2 -8°C).
English: Thyroid function
Maltese: Funzjoni tat-tirojde
English: None
Maltese: IU.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: Neoplasm progression (1 case of neoplasm progression in a female patient with a history of neurofibromatosis and radiation treatment), acrochordon, craniopharyngioma
Maltese: Komuni: Progressjoni ta' neoplażmu (1 każ ta' progressjoni ta' neoplażmu f'pazjent nisa bi storja medika ta' newrofibromatożi u kura bir-radjazzjoni), acrochordon, kranjofarinġjoma
English: - 0.7 mL in a 1 mL graduated syringe for Somatropin Biopartners 10 mg - 1.2 mL in a 2 mL graduated syringe for Somatropin Biopartners 20 mg
Maltese: - 0.7 mL f'siringa ggradwata ta' 1 mL għal Somatropin Biopartners 10 mg - 1.2 mL f'siringa ggradwata ta' 2 mL għal Somatropin Biopartners 20 mg
English: - 0.4 mL in a 1 mL graduated syringe for Somatropin Biopartners 2 mg - 0.6 mL in a 1 mL graduated syringe for Somatropin Biopartners 4 mg - 0.9 mL in a 1 mL graduated syringe for Somatropin Biopartners 7 mg
Maltese: - 0.4 mL f'siringa ggradwata ta' 1 mL għal Somatropin Biopartners 2 mg - 0.6 mL f'siringa ggradwata ta' 1 mL għal Somatropin Biopartners 4 mg - 0.9 mL f'siringa ggradwata ta' 1 mL għal Somatropin Biopartners 7 mg
English: IGF-I SDS in the range of +1 to +2
Maltese: SDS fil-medda ta' +1 sa +2
English: Common: Swelling face, acne, allergic dermatitis, hyperhidrosis, urticaria, rash Musculoskeletal and connective tissue disorders
Maltese: Nefħa tal-wiċċ, akne, dermatite allerġika, iperidrożi, urtikarja, raxx
English: The amino acid sequence of the active substance is identical to that of hGH of pituitary origin.
Maltese: Is-sekwenza ta' amino acids tas-sustanza attiva hi identika għal dik tal-hGH ta' oriġini pitwitarja.
English: Infections and infestations Common: Herpes simplex
Maltese: Herpes simplex
English: The apparent terminal half-life was about 16.8 h in adults, presumably reflecting slow absorption from the site of injection.
Maltese: Il-half-life terminali apparenti kienet ta' madwar 16.8 sigħat fl-adulti, u preżumibilment, tirrifletti l-assorbiment bil-mod mis-sit tal-injezzjoni.
English: General disorders and administration site conditions Very common: injection site swelling (30.8%)
Maltese: Komuni ħafna: nefħa fis-sit tal-injezzjoni (30.8%)
English: - Somatropin Biopartners 7 mg: One vial of powder delivers 7 mg somatropin, corresponding to 21 IU.
Maltese: - Somatropin Biopartners 7 mg: Kunjett wieħed bit-trab iforni 7 mg ta' somatropin, li jikkorrispondi għal 21 IU.
English: It is unlikely that the antibody responses to treatment with Somatropin Biopartners are of clinical relevance.
Maltese: Mhux probabbli li l-risponsi tal-antikorpi għall-kura b'Somatropin Biopartners huma ta' rilevanza klinika.
English: Powder and solvent for prolonged-release suspension for injection 20 mg powder in a vial and 1.5 mL solvent in a vial 1 vial of 20 mg powder
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod 20 mg ta' trab f'kunjett u 1.5 mL ta' solvent f'kunjett 1 kunjett b'20 mg ta' trab
English: Pack sizes:
Maltese: Komuni ħafna:
English: 4 vials of 20 mg powder
Maltese: 4 kunjetti b'20 mg ta' trab
English: Adults with childhood-onset of GHD
Maltese: Adulti b'GHD li tkun bdiet fit-tfulija
English: Somatropin Biopartners 20 mg should be reconstituted with 1.2 mL solvent.
Maltese: Somatropin Biopartners 20 mg għandu jiġi rrikostitwit b'1.2 mL ta' solvent.
English: Do not use any remaining solvent for a second preparation!
Maltese: M'għandek tuża l-ebda solvent li jkun fadal għat-tieni preparazzjoni!
English: General disorders and administration site conditions Very common: Oedema peripheral, oedema (local and generalised)* Common: Fatigue, pain, asthenia, face oedema, local swelling, oedema, thirst, malaise, chest pain, increased weight, injection site pain
Maltese: Komuni ħafna: Edema periferali, edema (lokali u ġeneralizzata)* Komuni: Għeja, uġigħ, astenja, edema fil-wiċċ, nefħa lokali, edema, għatx, telqa, uġigħ fis-sider, żieda fil-piż, uġigħ fis-sit tal-injezzjoni
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and agonists, ATC code: H01AC01
Maltese: Ormoni u analogi pitwitarji u ipotalamiċi, somatropin u agonisti ta' somatropin, Kodiċi ATC:
English: IGF-I SDS greater than +2
Maltese: SDS ikbar minn +2
English: Skin and subcutaneous tissue disorders Common: pigmentation disorder (1.1%)
Maltese: Komuni: disturb fil-pigmentazzjoni (1.1%)
English: 4 vials of 10 mg powder
Maltese: 4 kunjetti b'10 mg ta' trab
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: The somatropin in this medicinal product is synthesised in yeast (Saccharomyces cerevisiae).
Maltese: Is-somatropin f'dan il-prodott mediċinali hu sintetizzat fil-yeast (Saccharomyces cerevisiae).
English: - Somatropin Biopartners 4 mg: One vial of powder delivers 4 mg somatropin, corresponding to 12 IU.
Maltese: - Somatropin Biopartners 4 mg: Kunjett wieħed bit-trab iforni 4 mg ta' somatropin, li jikkorrispondi għal 12 IU.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: The adverse reactions most commonly reported were injection site related reactions, peripheral oedema, headache, myalgia, arthralgia, paraesthesia, hypothyroidism and decreased free thyroxine.
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati b'mod komuni kienu reazzjonijiet relatati mas-sit tal-injezzjoni, edema periferali, uġigħ ta' ras, mijalġja, artralġja, parastesija, ipotirojdiżmu u tnaqqis f'thyroxine ħielsa.
English: The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data):
Maltese: Komuni ħafna (>1/10); komuni (>1/100 sa <1/10); mhux komuni (>1/1,000 sa <1/100); rari (>1/10,000 sa <1/1,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli):
English: Common: Back pain, pain in extremities, arthralgia, shoulder pain, musculoskeletal stiffness, bone pain, muscular weakness, sensation of heaviness, tendonitis, joint swelling, arthritis, musculosceletal pain, myalgia*
Maltese: Komuni: Uġigħ fid-dahar, uġigħ fl-estremitajiet, artralġja, uġigħ fl-ispallejn, ebusija muskoluskeletrika, uġigħ fl-għadam, dgħufija fil-muskoli, sensazzjoni ta' toqol, tendonite, nefħa fil-ġogi, artrite, uġigħ muskoluskeletriku, mijalġja*
English: Injection site reactions
Maltese: Infezzjonijiet u infestazzjonijiet
English: In the children receiving Somatropin Biopartners a higher incidence of (non-serious) injection site reactions and a higher rate of formation of (non-neutralising) antibodies against somatropin as compared to children with daily administered recombinant growth hormone were observed (see also sections 4.4 and 4.8).
Maltese: Fit-tfal li jkunu qed jirċievu Somatropin Biopartners, ġew osservati inċidenza ogħla ta' reazzjonijiet fis-sit tal-injezzjoni (mhux serji) u rata ogħla ta' formazzjoni ta' antikorpi (mhux newtralizzanti) kontra somatropin meta mqabbla ma' tfal li ngħataw ormon tat-tkabbir rikombinanti kuljum (ara wkoll sezzjonijiet 4.4 u 4.8).
English: Common: Vertigo
Maltese: Komuni: Dardir
English: Some patients may develop antibodies to rhGH.
Maltese: Xi pazjenti jistgħu jiżviluppaw antikorpi għal rhGH.
English: The somatropin in this medicinal product is a polypeptide hormone of recombinant DNA origin.
Maltese: Is-somatropin f'dan il-prodott mediċinali hu ormon polypeptide ta' oriġini ta' DNA rikombinanti.
English: Somatropin Biopartners 2 mg powder and solvent for prolonged-release suspension for injection Somatropin Biopartners 4 mg powder and solvent for prolonged-release suspension for injection Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection
Maltese: Somatropin Biopartners 2 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Somatropin Biopartners 4 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Somatropin Biopartners 7 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: One powder vial delivers 7 mg of somatropin (21 IU).
Maltese: Kunjett wieħed bit-trab iforni 7 mg ta' somatropin (21 IU).
English: Safety and efficacy in adults with GHD was assessed in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study.
Maltese: III, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, bi grupp parallel u multiċentriku.
English: 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
Maltese: EU/1/13/849/006 1 kunjett bit-trab u 1 kunjett bis-solvent EU/1/13/849/007 4 kunjetti bit-trab u 4 kunjetti bis-solvent
English: 4 vials of powder and 4 vials of solvent.
Maltese: 4 kujetti bit-trab u 4 kunjetti bis-solvent.
English: - oestrogen taken orally or other sex hormones - medicines to treat epilepsy - cyclosporine: a medicine to suppress the immune system
Maltese: - estroġenu li jittieħed mill-ħalq jew ormoni oħrajn tas-sess - mediċini għall-kura tal-epilessija - cyclosporine: mediċina li trażżan is-sistema immuni
English: Antibodies
Maltese: Antikorpi
English: 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
Maltese: EU/1/13/849/004 1 kunjett bit-trab u 1 kunjett bis-solvent EU/1/13/849/005 4 kunjetti bit-trab u 4 kunjetti bis-solvent
English: No accumulation of hGH following multiple dosing of this medicinal product has been observed.
Maltese: Ma ġiet osservata l-ebda akkumulazzjoni ta' hGH wara dożi multipli ta' dan il-prodott mediċinali.
English: Non-clinical pharmacokinetic and pharmacodynamic studies in dogs and juvenile monkeys showed that Somatropin Biopartners released recombinant hGH in a prolonged manner and increased serum IGF-I for an extended period up to 5-6 days.
Maltese: Studji mhux kliniċi farmakokinetiċi u farmakodinamiċi li saru fuq klieb u xadini ġuvenili wrew li Somatropin Biopartners reħa hGH rikombinanti b'mod fit-tul, u żieda is-serum IGF-I għal perjodu estiż ta' sa 5-6 ijiem.
English: 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.
Maltese: Id-dożaġġ ta' somatropin għandu jitnaqqas f'każijiet ta' edema persistenti jew parastesija severa, sabiex jiġi evitat l-iżvilupp tas-sindrome tal-carpal tunnel.
English: The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 6-month controlled clinical study with 151 adult patients with GHD of adult or childhood-onset and in a 6-month extension study.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati waqt il-kura b'Somatropin Biopartners fi studju kliniku kkontrollat li dam 6 xhur, li fih ħadu sehem 151 pazjenti adulti b'GHD li bdiet meta l-individwu kien adult jew fit-tfulija u fi studju ta' estensjoni ta' 6 xhur.
English: From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions to the embryo or foetus.
Maltese: Minn studji ta' tossiċità riproduttiva mwettqa bi prodotti somatropin oħrajn, m'hemm l-ebda evidenza ta' riskju miżjud ta' reazzjonijiet avversi għall-embriju jew il-fetu.
English: Musculoskeletal and connective tissue disorders Common: arthralgia (1.1%), pain in extremities (5.1%)
Maltese: Komuni: artralġja (1.1%), uġigħ fl-estremitajiet (5.1%)
English: The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
Maltese: Il-profil tas-sigurtà ta' Somatropin Biopartners ġeneralment hu konsistenti mal-profil ta' sigurtà magħrufa sew ta' kuri ta' kuljum bl-ormon tat-tkabbir.
English: - Somatropin Biopartners 20 mg: One vial of powder delivers 20 mg somatropin, corresponding to 60 IU.
Maltese: - Somatropin Biopartners 20 mg: Kunjett wieħed bit-trab iforni 20 mg ta' somatropin, li jikkorrispondi għal 60
English: IGF-I SDS in the range of -1 to +1 and more than 1 SDS increase from Baseline Maintain
Maltese: SDS fil-medda ta' -1 sa +1 u iktar minn żieda ta' 1 SDS mil-Linja Bażi
English: - Somatropin Biopartners 10 mg: One vial of powder delivers 10 mg somatropin, corresponding to 30 IU.
Maltese: - Somatropin Biopartners 10 mg: Kunjett wieħed bit-trab iforni 10 mg ta' somatropin li jikkorrispondu għal 30 IU.
English: For children and adolescents (2 to 18 years)
Maltese: Għal tfal u adolexxenti (sentejn sa 18-il sena)
English: Somatropin Biopartners 4 mg should be reconstituted with 0.6 mL solvent.
Maltese: Somatropin Biopartners 4 mg għandu jiġi rikostitwit b'0.6 mL ta' solvent.
English: Somatropin Biopartners 7 mg should be reconstituted with 0.9 mL solvent.
Maltese: Somatropin Biopartners 7 mg għandu jiġi rikostitwit b'0.9 mL ta' solvent.
English: Not known: Insulin resistance*
Maltese: Reżistenza għall-insulina*
English: Gastrointestinal disorders Common: vomitting (1.1%), abdominal pain (1.1%)
Maltese: Komuni: rimettar (1.1%), uġigħ addominali (1.1%)
English: After reconstitution, 1 mL of suspension contains 20 mg (20 mg/mL).
Maltese: Wara r-rikostituzzjoni, 1 mL ta' suspensjoni ikun fih 20 mg (20 mg/mL).
English: This pivotal phase III study comprised 151 adult patients with GHD of adult- or childhood-onset and lasted 6 months.
Maltese: III kien jinkludi 151 pazjent adult b'GHD li bdiet meta kienu adulti jew fit-tfulija, u dam 6 xhur.
English: After preparation, 1 mL of suspension contains 20 mg somatropin (20 mg/mL).
Maltese: Wara r-rikostituzzjoni, 1 mL ta' suspensjoni jkun fih 20 mg ta' somatropin (20 mg/mL).
English: INFORMATION IN BRAILLE Somatropin Biopartners 7 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Somatropin Biopartners 7 mg
English: Common: Tachycardia, heart rate abnormal/irregular Vascular disorders
Maltese: Komuni: Takikardija, rata anormali/irregolari tat-taħbit l-qalb
English: One powder vial delivers 10 mg of somatropin (30 IU).
Maltese: Kunjett wieħed bit-trab iforni 10 mg ta' somatropin (30 IU).
English: One powder vial delivers 4 mg of somatropin (12 IU).
Maltese: Kunjett wieħed bit-trab iforni 4 mg ta' somatropin (12 IU).
English: INFORMATION IN BRAILLE Somatropin Biopartners 4 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Somatropin Biopartners 4 mg
English: Patient bodyweight (kg)
Maltese: Piż tal-ġisem tal-pazjent (kg)
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Maltese: Pazjenti li jkollhom id-dijabete, intolleranza għal glucose, jew fatturi ta' riskju addizzjonali għad-dijabete, għandhom jiġu mmonitorjati mill-qrib matul it-terapija b'somatropin.
English: Somatropin Biopartners contains human growth hormone, also called somatropin.
Maltese: Somatropin Biopartners fih l-ormon tat-tkabbir uman, imsejjaħ ukoll somatropin.
English: After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin.
Maltese: Wara li t-trab jitħallat b'mod uniformi mas-solvent ipprovdut, din il-mediċina tiġi injettata taħt il-ġilda.
English: If you are heavier than 40 kg, two vials must be used.
Maltese: Jekk tiżen iktar minn 40 kg, għandhom jintużaw żewġ kunjetti.
English: Large doses of somatropin may impair glucose tolerance.
Maltese: Dożi kbar ta' somatropin jistgħu jindebbolixxu t-tolleranza għall-glucose.
English: Few patients discontinued treatment due to injections site reactions, see section 4.8.
Maltese: Ftit pazjenti waqqfu l-kura minħabba reazzjonijiet fis-sit tal-injezzjoni, ara sezzjoni 4.8.
English: Do not use Somatropin Biopartners
Maltese: Tużax Somatropin Biopartners
English: Somatropin Biopartners 10 mg should be reconstituted with 0.7 mL solvent.
Maltese: Somatropin Biopartners 10 mg għandu jiġi rrikostitwit b'0.7 mL ta' solvent.
English: Tel: +49 (0) 7121 948 7756 Fax:+49 (0) 7121 346 255 e-mail: info@biopartners.de
Maltese: Fax:+49 (0) 7121 346 255 e-mail: info@biopartners.de
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In a randomized, parallel-group, multicentre Phase III study, 178 children between 3 and 12 years of age with organic and/or idiopathic GHD were randomised to receive either weekly administered Somatropin Biopartners (0.5 mg/kg/week) or daily administered recombinant hGH (0.03 mg/kg/day) for 12 months.
Maltese: III, 178 tifel/tifla li kellhom bejn 3 u 12-il sena b'GHD organika u/jew idjopatika, intgħażlu b'mod każwali biex jirċievu jew Somatropin Biopartners darba fil-ġimgħa (0.5 mg/kg/ġimgħa) jew hGH rikombinanti (0.03 mg/kg/jum) għal 12-il xahar.
English: - Somatropin Biopartners 2 mg: One vial of powder delivers 2 mg somatropin, corresponding to 6 IU.
Maltese: - Somatropin Biopartners 2 mg: Kunjett wieħed bit-trab iforni 2 mg ta' somatropin, li jikkorrispondi għal 6
English: None or -0.5 mg (all patients)
Maltese: Xejn jew -0.5 mg (il-pazjenti kollha)
English: One powder vial delivers 2 mg of somatropin (6 IU).
Maltese: Kunjett wieħed bit-trab iforni 2 mg ta' somatropin (6 IU).
English: After preparation, 0.5 mL of suspension contains 10 mg somatropin (20 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.5 mL ta' suspensjoni jkun fih 10 mg ta' somatropin (20 mg/mL).
English: Scoliosis
Maltese: Raġel
English: After preparation, 0.7 mL of suspension contains 7 mg somatropin (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.7 mL ta' suspensjoni jkun fih 7 mg ta' somatropin (10 mg/mL).
English: Following repeated weekly subcutaneous administration of a mean dose of 4.4 mg prolonged release somatropin to adults with GHD the Cmax and tmax of plasma hGH were about 4.5 ng/mL and 15 h respectively.
Maltese: Wara għoti ripetut kull ġimgħa taħt il-ġilda ta' doża medja ta' 4.4 mg ta' somatropin li jerħi l-mediċina bil-mod lil adulti b'GHD, is-Cmax u t-tmax tal-hGH fil-plażma kienu ta' madwar 4.5 ng/mL u 15-il siegħa rispettivament.
English: Somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Maltese: L-għoti ta' somatropin jista' jżid it-tneħħija ta' komposti li hu magħruf li jiġu metabolizzati mill-isoenzimi ta' ċitokrom P450.
English: Rare, may affect up to 1 in 100 people - abnormal sensation such as prickling, tingling and itchiness - high blood pressure
Maltese: Rari, jistgħu jaffettwaw sa 1 minn kull 100 persuna - sensazzjoni mhux normali bħal tingiż, tnemnim u ħakk - pressjoni tad-demm għolja
English: 1 vial of powder and 1 vial of solvent.
Maltese: 1 kujett bit-trab u 1 kunjett bis-solvent.
English: In patients with hypopituitarism receiving thyroxin replacement therapy, hyperpituitarism may develop.
Maltese: F'pazjenti li jkollhom ipopitwitariżmu u li jkunu qed jirċievu terapija ta' sostituzzjoni b'thyroxin, jista' jiżviluppa iperpitwitariżmu.
English: After reconstitution, 0.7 mL of suspension contains 7 mg (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.7 mL ta' suspensjoni ikun fih 7 mg (10 mg/mL).
English: The treatment goal should be IGF-I concentrations within -0.5 and +1.5 SDS of the age corrected mean.
Maltese: SDS tkun fil-medda fil-mira ta' -0.5 sa +1.5.
English: Hold the syringe upright.
Maltese: Prekawzjonijiet oħra
English: After preparation, 0.4 mL of suspension contains 4 mg somatropin (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.4 mL ta' suspensjoni jkun fih 4 mg ta' somatropin (10 mg/mL).
English: Female (on oral oestrogen)
Maltese: Mara (mhux fuq estroġenu orali) Mara (fuq estroġenu orali)
English: Because human growth hormone (hGH) may induce a state of insulin resistance and hyperglycaemia, patients treated with this medicinal product should be monitored for evidence of glucose intolerance.
Maltese: Minħabba li l-ormon tat-tkabbir uman (hGH) jista' jinduċi stat ta' reżistenza għall-insulina u ipergliċemija, pazjenti kkurati dan il-prodott mediċinali għandhom jiġu ssorveljati għal evidenza ta' intolleranza għal glucose.
English: After reconstitution, 0.4 mL of suspension contains 4 mg (10 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.4 mL ta' suspensjoni ikun fih 4 mg (10 mg/mL).
English: Pack size: 4 vials of powder and 4 vials of solvent.
Maltese: Daqs tal-pakkett: 4 kunjetti ta' trab u 4 kunjetti ta' solvent.
English: Vascular disorders Rare: hypertension*
Maltese: Mhux komuni: Ġinekomastija*
English: Clinical trials included approximately 530 patients treated with Somatropin Biopartners.
Maltese: Il-provi kliniċi kienu jinkludu madwar 530 pazjent ikkurati b'Somatropin Biopartners.
English: Following repeated weekly subcutaneous administration of a mean dose of 0.5 mg/kg prolonged release somatropin to prepubertal children with GHD the Cmax and tmax of plasma hGH were about 60.7 ng/mL and 12.0 h respectively.
Maltese: Wara għoti ripetut kull ġimgħa taħt il-ġilda ta' doża medja ta' 0.5 mg/kg ta' somatropin li jerħi l-mediċina bil-mod lil tfal qabel l-età tal-pubertà b'GHD, is-Cmax u t-tmax tal-hGH fil-plażma hGH kienu ta' madwar 60.7 ng/mL u 12-il siegħa rispettivament.
English: For dosage instruction, see table below.
Maltese: Segwi l-istruzzjonijiet b'attenzjoni pass pass.
English: Common, may affect up to 1 in 10 people - tiredness or weight gain due to underactive thyroid gland - reduced function of the adrenal gland (which may show as tiredness) - mild blood sugar increase - headache, lethargy (lack of energy), dizziness - vomiting, stomach ache - discoloration of the skin - pain in joints, arms or legs - pain, discoloration, swelling, hardening, reddening or feeling of warmth at the injection site - tissue swelling - fever - changes in blood levels of certain hormones
Maltese: Komuni, jistgħu jaffettwaw sa 1 minn kull 10 persuni - għeja jew żieda fil-piż minħabba glandola tat-tirojde mhux attiva biżżejjed - tnaqqis fil-funzjoni tal-glandola adrenali (li tista' tidher bħala għeja) - żieda ħafifa fil-livell taz-zokkor fid-demm - uġigħ ta' ras, letarġija (nuqqas ta' enerġija), sturdament - rimettar, uġigħ fl-istonku - tibdil fil-kulur tal-ġilda - uġigħ fil-ġogi, fid-dirgħajn jew fir-riġlejn - uġigħ, tibdil fil-kulur, nefħa, ebusija, ħmura jew tħoss is-sħana fis-sit tal-injezzjoni - nefħa tat-tessut - deni - tibdil fil-livelli fid-demm ta' ċerti ormoni
English: After reconstitution, 0.5 mL of suspension contains 10 mg (20 mg/mL).
Maltese: Wara r-rikostituzzjoni, 0.5 mL ta' suspensjoni jkun fih 10 mg (20 mg/mL).
English: - 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).
Maltese: - Somatropin Biopartners 7 mg: 7 mg (21 IU) ta' somatropin bħala trab f'kunjett tal-ħġieġ magħluq b'tapp tal-lastku (butyl) u għatu blu ċar tat-tip flip-off (aluminju u plastik) u 1.5 mL ta' solvent (medium chain triglycerides) f'kunjett tal-ħġieġ b'tapp tal-lastku (butyl).