natgillin/translations-raw huggingface dataset:
Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Zdravilo Preotact se uporablja za zdravljenje osteoporoze pri ženskah po menopavzi s povečanim tveganjem za zlome.
Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
Bolnice, ki so prejemale zdravilo Preotact, so imele po 18 mesecih za 61% manjše relativno tveganje novega vretenčnega zloma v primerjavi z bolnicami, ki so prejemale placebo.
• You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
• Pripravljeno zdravilo v napolnjenem injekcijskem peresniku je uporabno največ 28 dni, če ga shranjujete v hladilniku.
• mannitol,
• manitol
• Screw the needle off.
• Odvijte iglo.
In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
V drugem letu študije so ženske, ki so prvotno prejemale zdravilo Preotact, naključno razporedili v skupini, ki sta prejemali bodisi alendronat bodisi placebo,
After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Po pripravi en odmerek z 71,4 mikrolitri vsebuje 100 mikrogramov obščitničnega hormona.
The pre-filled pen before mixing:
Napolnjen injekcijski peresnik pred mešanjem:
Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Pri bolnicah, katerih serumske ravni kalcija so po 6 mesecih v normalnem območju, spremljanje po 6. mesecu ni priporočljivo.
Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium.
Pri bolnicah, pri katerih uvedemo zdravljenje z zdravilom Preotact, moramo spremljati morebitne zvišane ravni kalcija v serumu in/ali urinu v 1., 3. in 6. mesecu.
• if you shall have or previously have had radiation therapy to the skeleton;
• če se boste ali ste se kdaj zdravili z obsevanjem okostja;
What Preotact looks like and contents of the pack
Izgled zdravila Preotact in vsebina pakiranja
Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Po zdravljenju z zdravilom Preotact lahko bolnice zdravimo z difosfonatom, da še povečamo mineralno gostoto kosti (glejte poglavje 5.1).
This includes any possible side effects not listed in this leaflet..
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
Klorovodikova kislina, razredčena (za uravnavanje pH)
• nausea.
• slabost.
• decreased muscle strength, muscle cramps, dizziness,
• zmanjšana mišična moč, mišični krči, omotica,
When you are not using it, put the pre-filled pen back into the refrigerator.
Ko napolnjenega injekcijskega persnika ne uporabljate, ga shranite v hladilniku.
• have a high level of calcium in your urine;
• imate visoko raven kalcija v urinu,
After mixing
Po mešanju:
Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Zato zdravila Preotact ne smemo uporabljati pri bolnicah s hudo okvaro ledvic (glejte poglavje 4.3).
EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
ZDRAVILA Navedba smiselno ni potrebna.
In the Preotact clinical program, accidental overdose has been reported.
V kliničnem programu zdravila Preotact so poročali o nenamernem prevelikem odmerjanju.
From the knowledge of the mechanism of action, combined use of Preotact and cardiac glucosides may predispose patients to digitalis toxicity if hypercalcemia develops (see section 4.4).
Na podlagi poznavanja mehanizma delovanja lahko sklepamo, da kombinacija zdravila Preotact in srčnih glukozidov lahko vpliva na predispozicijo za toksičnost digitalisa, če se pojavi hiperkalciemija
- If you have any further questions, ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Podobno se je volumetrični trabekularni BMD celotnega kolka povečal za 9% v prvi omenjeni skupini, za 6% v drugi omenjeni skupini in za 2% v zadnji omenjeni skupini.
The content of the cartridge is reconstituted in the pen.
Vsebina vložka se pripravi v peresniku.
Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
predstavlja le 5-30% krožečih oblik molekule, 70-95% ostalih oblik pa so fragmenti s karboksi-koncem.
• Put the outer needle cover on.
• Nataknite zunanji pokrovček igle.
Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Obščitnični hormon se presnovi v jetrih, v manjšem obsegu tudi v ledvicah.
Do not shake the pre-filled pen
Ne pretresajte napolnjenega injekcijskega peresnika
Press the blue injection button until it is fully depressed -then count slowly to 10 and remove the needle from your skin.
Pritisnite na modri injekcijski gumb do konca, da se zaskoči - potem počasi štejte do
No studies have been conducted in patients with severe hepatic impairment.
Študij pri bolnikih s hudo okvaro jeter niso opravili.
Common (may affect up to 1 in 10 people):
Občasni (lahko se pojavijo pri 1 od 10 bolnikov):
• You can store the unmixed pre-filled pen at temperatures between 2-25°C.
• Napolnjen injekcijski peresnik z nezmešanim zdravilom lahko shranjujete pri temperaturah od 2 °C25 °C.
• Press the yellow release button to release the blue injection button.
• Pritisnite na rumeni sprožilni gumb, da s tem sprostite modri injekcijski gumb.
The other ingredients are: The powder contains:
-Druge sestavine zdravila (pomožne snovi) so:
Your doctor will perform blood and/or urine tests to measure the level of calcium in your blood and/or urine at month 1, 3 and 6 after starting your treatment with Preotact.
Vaš zdravnik bo po enem mesecu, treh in šestih mesecih od začetka zdravljenja z zdravilom Preotact opravili preiskave krvi in/ali urina za merjenje ravni kalcija v krvi in/ali urinu.
Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
4.1 Terapevtske indikacije Zdravilo Preotact je indicirano za zdravljenje osteoporoze pri ženskah po menopavzi, ki imajo povečano tveganje za zlome (glejte poglavje 5.1).
A total of 2532 patients (1286 Preotact and 1246 placebo), aged 45-94 years (8.1% 45-54 years and 11.4% > 75 years), were randomised to receive 100 micrograms/day or placebo with daily calcium (700 mg) and vitamin D (400 IU) supplementation.
45 do 94 let (8,1% starih od 45 do 54 let in 11,4% starejših od 75 let), je bilo naključno razporejenih v skupino, ki je prejemala 100 µg/dan, ali v skupino, ki je prejemala placebo.
Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Objemna zaporka (ki vsebuje zamašek iz gume): aluminij.
Marketing Authorisation Holder NPS Pharma Holdings Limited Grand Canal House 1 Grand Canal Street Upper Dublin 4
Imetnik dovoljenja za promet z zdravilom NPS Pharma Holdings Limited Grand Canal House
• if you suffer from severe liver disease;
• če imate hude težave z jetri.
Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
60-90 % krožečih oblik molekule.
• Never store your pre-filled pen with the needle attached.
• Napolnjenega injekcijskega peresnika nikoli ne shranjujte z nameščeno iglo.
• Screw the pre-filled pen together until the clear front part and the pen body meet.
• Privijte napolnjen injekcijski peresnik do konca, dokler se prozorni sprednji del ne spoji s telesom peresnika.
• Put the pre-filled pen back into the refrigerator immediately after you have used it.
• Napolnjen injekcijski peresnik po uporabi nemudoma znova shranite v hladilniku.
No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Pri bolnicah z blago do zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/min) ni treba prilagajati odmerka.
• Keep Preotact protected from light
• Zdravilo Preotact shranjujte zaščiteno pred svetlobo.
Keep this medicine out of sight and reach of children.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
• citric acid monohydrate,
• citronsko kislino monohidrat
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone
IME ZDRAVILA IN POT(I) UPORABE Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje obščitnični hormon subkutana uporaba
The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Fragmenti, ki izhajajo iz karboksi-konca, pa se sproščajo nazaj v kri in se očistijo v ledvicah.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Če bolnice s prehrano ne zaužijejo zadosti kalcija in vitamina D, morajo prejemati dodatke teh snovi.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
In response to subcutaneous doses of Preotact (100 micrograms parathyroid hormone), serum total calcium levels increase gradually and reach peak concentration (mean increase in 129 patients, 0.15 mmol/l) at approximately 6 to 8 hours after dosing.
Kot odziv na podkožno injicirane odmerke zdravila Preotact (100 µg obščitničnega hormona), se postopno višajo serumske koncentracije celokupnega kalcija in dosežejo najvišjo koncentracijo (povprečno zvišanje pri 129
Infections and infestations Uncommon
Infekcijske in parazitske bolezni
Pre-filled pen (before reconstitution): Do not store above 25°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Napolnjen injekcijski peresnik (pred pripravo): Shranjujte pri temperaturi do 25 °C.
Press the yellow release button to release the blue injection button.
Pritisnite rumeni sprožilni gumb, s čimer sprostite modri injekcijski gumb.
The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent.
Prva komora vsebuje 1,61 mg obščitničničnega hormona v obliki praška in druga komora vsebuje1,13 ml vehikla.
• with unexplained elevations of bone-specific alkaline phosphatase
• z zvišanimi ravnmi za kosti značilne alkalne fosfataze brez ugotovljenega vzroka
The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
V spodnji preglednici je pregled neželenih učinkov, kjer je bila pojavnost v skupini bolnic, ki so prejemale obščitnični hormon za 0,5% višja kot v skupini bolnic, ki so prejemale placebo.
• increased level of alkaline phosphatase in the blood ,
• zvišana raven alkalne fosfataze v krvi,
Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na napolnjenem injekcijskem peresniku in na škatlici poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
• hydrochloric acid,
• klorovodikovo kislino
Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
Šlo je za dveletno, randomizirano, s placebom nadzorovano, multicentrično, dvojno slepo preskušanje zdravila Preotact in alendronata za zdravljenje pomenopavzne osteoporoze v monoterapiji ali v kombinaciji.
Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Držite prozorni sprednji del napolnjenega injekcijskega peresnika in do konca privijte iglo na prozorni sprednji del napolnjenega injkecijskega peresnika.
• Release residual air (prime the pen)
• Sprostite odvečen zrak (pripravite peresnik)
There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
V študiji pri 6 moških in 6 ženskah z zmerno okvaro jeter so odkrili manjše (približno 20%) zvišanje za povprečno osnovnico popravljene izpostavitve (AUC) obščitničnemu hormonu v primerjavi z ujemajočo se skupino 12 preiskovancev z normalno jetrno funkcijo.
Keep the product protected from light.
Zdravilo shranjujte zaščiteno pred svetlobo.
The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact.
Pri bolnicah, zdravljenih z zdravilom Preotact, se je BMD ledvenega predela hrbtenice povečal za 6,8%, BMD femoralnega vratu pa za 2,2% nad izhodiščnimi vrednostmi.
4.9 Overdose
4.9 Preveliko odmerjanje Znaki in simptomi
After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in Escherichia coli by recombinant DNA technology For a full list of excipients, see section 6.1.
Po rekonstituciji en odmerek z 71,4 mikrolitri vsebuje 100 mikrogramov obščitničnega hormona, ki je pridobljen v Escherichia coli s tehnologijo rekombinantne DNA.
• Do not store the pre-filled pen with the needle on.
• Ne shranjujte napolnjenega injekcijskega peresnika z nataknjeno iglo.
Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001).
Pri merjenju ciljev študije so opazili statistično značilno povečanje BMD kolka, in sicer v skupini bolnic, ki so prejemale zdravilo Preotact: skupno 1,0%, v femoralnem vratu 1,8%, v trohantru 1,0%, v primerjavi s skupino bolnic, ki so prejemale placebo: skupno -1,1%, v femoralnem vratu -0,7%, v trohantru -0,6% (p<0,001).
No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
Pri bolnicah z blago do zmerno okvaro jeter (skupno število točk po lestvici Child-Pugh od 7 do 9) ni treba prilagajati odmerka.
Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen Parathyroid hormone
Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku obščitnični hormon
Do not use Preotact • if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed
• če ste alergični na obščitnični hormon ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Elevated serum calcium was observed during Preotact treatment.
Med zdravljenjem z zdravilom Preotact so opazili zvišane serumske ravni kalcija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega hormona, kar ustreza 14 odmerkom.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months.
Volumetrični trabekularni BMD v ledvenem predelu hrbtenice se je od izhodiščnih vrednosti v 12 mesecih povečal za 26% v skupini, ki je prejemala zdravilo Preotact, za 13% v skupini, ki je prejemala zdravilo Preotact in alendronat, in za 11% v skupini, ki je prejemala alendronat.
• You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C.
• Napolnjen injekcijski peresnik z zmešanim zdravilom lahko shranjujete do 7 dni pri sobni temperaturi od 2 °C- 25 °C.
Pre-filled pen(after reconstitution): Store in a refrigerator (2-8°C).
Napolnjen injekcijski peresnik (po pripravi): Shranjujte v hladilniku (2 °C - 8 °C).
Preotact is a powder and solvent for solution for injection in a pre-filled pen.
Zdravilo Preotact je prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled pen
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
• Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4).
(glejte sliki 3 in 4).
• constipation, diarrhoea,
• zaprtost, driska,
Reconstituted solution: Store in a refrigerator (2-8°C).
Pripravljena raztopina: Shranjujte v hladilniku (2 °C - 8 °C).
Every day you have to check that the medicine is clear, add a new needle, take the injection in your abdomen and then throw away the needle before storing your pre-filled pen in the refrigerator (2-8°C).
Vsak dan morate preveriti, če je zdravilo bistro, dodati novo iglo, se zbosti v trebuh in nato zavreči iglo,
• increased level of calcium in the blood,
• zvišana raven kalcija v krvi,
The pre-filled pen after mixing:
Napolnjen injekcijski peresnik po mešanju:
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
Povečki BMD celotnega kolka so bili 1,9% v prvi omenjeni skupini,
Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse.
S prsti stisnite kožno gubo na trebuhu in naredite vbod z injekcijsko iglo pod kotom 90°,
Langebjerg 1, 4000 Roskilde
Nycomed Danmark ApS Langebjerg 1, 4000 Roskilde Danska
• stomach upset, vomiting,
• razdražen želodec, bruhanje, • utrujenost.
• sodium chloride,
• natrijev klorid
Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Obščitnični hormon se v jetrih učinkovito odstranjuje iz krvi s procesi, ki jih posredujejo receptorji,
Preotact is available in packs of 2 pre-filled pens.
Zdravilo je na voljo v pakiranju z 2 napolnjenima injekcijskima peresnikoma.
Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Ko je raztopina v vložku pripravljena, lahko zdravilo shranjujete pri temperaturi do 25 °C do 7 dni v 28-dnevnem obdobju uporabnosti.
Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding.
Če ste noseči ali če dojite, ne uporabljajte zdravila Preotact.
There are no data available from the use of parathyroid hormone in women of childbearing potential, during pregnancy and breast feeding.
4.6 Plodnost, nosečnost in dojenje Ni podatkov o uporabi obščitničnega hormona pri ženskah v rodni dobi, med nosečnostjo in med dojenjem.
Each cartridge inside the prefilled pen contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses).
En vložek znotraj napolnjenega injekcijskega peresnika vsebuje po 1,61 mg obščitničnega hormona in 1,13 ml vehikla (14 odmerkov).
Injection site irritation
Eritem na mestu injiciranja Utrujenost
Clinical efficacy
KLINIČNI PODATKI
The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone.
študiji so vključili 2642 pomenopavznih žensk z osteoporozo, od katerih jih je 1341 prejemalo obščitnični hormon.
There is no data available in patients with severe hepatic impairment.
O odmerjanju pri bolnicah s hudo okvaro jeter ni podatkov.
• increased level of calcium in the urine,
• zvišana raven kalcija v urinu,
• suffer from kidney stones;
• imate ledvične kamne,
Measuring of the calcium levels in the blood and/or urine Your doctor will check your response to the treatment at regular intervals.
Vaš zdravnik bo v rednih časovnih presledkih preverjal odziv na zdravljenje.
Preotact is available in a pack with 2 pre-filled pens.
Zdravilo je na voljo v pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika.
The medicinal product is supplied in a pre-filled pen containing a dual-chamber cartridge.
Zdravilo je na voljo v napolnjenem injekcijskem peresniku, ki vsebuje en vložek z dvema komoroma.
Preotact should be used with caution in patients with active or previous urolithiasis.
Zdravilo Preotact moramo pri bolnicah z aktivno urolitiazo ali anamnezo te bolezni uporabljati previdno.
Dysgeusia
Dizgevzija Parozmija
Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega hormona, kar ustreza 14 odmerkom.
Injection site erythema
Draženje na mestu injiciranja
LIST OF EXCIPIENTS
Števec odmerkov
Pull the cap straight off from the front end of the pre-filled pen.
Povlecite in odstranite pokrov s sprednjega dela napolnjenega injekcijskega peresnika.
The volume of distribution at steady-state following intravenous administration is approximately 5.4 l. Interindividual variability in the volume of distribution of parathyroid hormone is about 40%.
Interindividualna variabilnost volumna porazdelitve obščitničnega hormona je približno 40%.
Parosmia
SERIJE
• increased level of uric acid in the blood,
• zvišana raven sečne kisline v krvi,
Wash your hands with soap and water before you handle the pre-filled pen.
Pred rokovanjem z napolnjenim injekcijskim peresnikom si umijte roke z vodo in milom.
In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p<0.001).
6,5% v primerjavi z -0,3% pri bolnicah, ki so prejemale placebo (p<0,001).
• You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C)
• Pripravljen napolnjen injekcijski peresnik lahko shranjujete izven hladilnika (pri temperaturi do 25 °C) največ do 7 dni v 28-dnevnem obdobju uporabnosti.
Keep the pre-filled pen in the outer carton in order to protect from light.
Za zagotovitev zaščite pred svetlobo shranjujte napolnjen injekcijski peresnik v zunanji škatli.
What you need to know before you use Preotact
Kaj morate vedeti, preden boste uporabili zdravilo Preotact Ne uporabljajte zdravila Preotact:
Hepatic impairment
Pogosti Glavobol Omotica
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
1,61 mg obščitničnega hormona in 1,13 ml vehikla (14 odmerkov)
Asthenia
Zdravilo
Vomiting
Vehikel
Posology The recommended dose is 100 micrograms of parathyroid hormone administered once-daily
Priporočeni odmerek je 100 µg obščitničnega hormona enkrat dnevno.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not shake the reconstituted solution Read the package leaflet before use Subcutaneous use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljene raztopine ne stresajte.
Talk to your doctor or pharmacist before using Preotact if you:
Pred začetkom uporabe zdravila Preotact se posvetujte s svojim zdravnikom ali s farmacevtom, če
Check with your doctor or pharmacist if you are not sure.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
2 pre-filled pens per pack.
škatla z 2 napolnjenima injekcijskima peresnikoma
Name and address of the manufacturer responsible for batch release Nycomed Danmark ApS
Ime in naslov izdelovalca, odgovornega za sproščanje serije
• abdominal pain,
• bolečine v trebuhu,
• with severe hepatic impairment
• s hudimi okvarami ledvic • s hudimi okvarami jeter