natgillin/translations-raw huggingface dataset:
In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
V kliničnem preskušanju III. faze (V87P13) so vključili 2.693 odraslih oseb, od katerih je 2.566 oseb s 3-tedenskim presledkom prejelo dva odmerka cepiva AFLUNOV (A/Vietnam/1194/2004).
Adults (18-59 years)a
Odrasli (18-59 let)
MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively.
Rezultati MN za homologni A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 57 % (50-64) do 79 % (68-87) in stopnjo serokonverzije v razponu od 55 % (48-62) do 58 % (47-69).
Adjuvant MF59C.1 containing: squalene
** izraženo v mikrogramih hemaglutinina Adjuvans MF59C.1 vsebuje: skvalen
AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3).
neomicin sulfata, formaldehida in cetiltrimetilamonijevega bromida, ki se uporabljajo v proizvodnem procesu (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
sevu A/turkey/Turkey/1/2005 (H5N1) podoben sev (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov hemaglutinina
• Fever and nausea
konvulzije in nevritis
Elderly (61-91 years)a
Starejši (61-91 let)
** geometric mean ratios of SRH
*** Razmerja geometričnih srednjih vrednosti (GMR) za SRH.
MicroNeutralisation (MN) results against homologous A/Vietnam/1194/2004) indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Rezultati mikronevtralizacije (MN) za homologni A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 67 % (60-74) do 85 % (78-90) in stopnjo serokonverzije v razponu od 65 % (58-72) do 83 % (77-89).
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows:
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 (A/Vietnam/1194/2004 in A/turkey/Turkey/1/2005) pri osebah, starih 61 let ali več (manjše število oseb je bilo starih nad 70 let, N = 123), izmerjeno s testom SRH in ocenjeno v treh kliničnih preskušanjih, so bili, kot sledi:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni (hemaglutinin in nevraminidaza)* virusa gripe seva:
Seroconversion rate (95%CI)°
Faktor serokonverzije (95-odstotni
Some heterologous immune response against A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2.1) and A/ Indonesia/5/2005 (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
*** GMR za SRH Podatki o navzkrižni odzivnosti pri odraslih Navzkrižni imunski odziv, ki ga je izzval A/Vietnam/1194/2004, na A/turkey/Turkey/1/2005 in A/Indonesia/5/2005 Nekaj heterolognega imunskega odziva proti sevu A/turkey/Turkey/1/2005 (NIBRG23; gruča 2.2.1) in A/Indonesia/5/2005 (gruča 2.1) so zaznali tako po drugem kot po tretjem cepljenju, kar kaže na križno reaktivnost cepiva gruče 1 proti sevom gruče 2.
Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions.
Stopnje serokonverzije proti homolognemu sevu A/turkey/Turkey/1/2005 so bili v razponu od 37,50 % do 43,10 % pri zdravih odraslih osebah ter od 19,18 % do 26,47 % pri odraslih osebah z zmanjšanim imunskim odzivom ali osnovnimi bolezenskimi stanji.
Elderly (61-84 years)a
Starejši (61-84 let)
SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, revealed seroprotection and seroconversion rates of 100% (74100) and an 18-fold increase in SRH area (GMR).
so pokazali stopnjo serozaščite in serokonverzije 100 % (74-100) ter 18-kratno povečanje površine
Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali nespecifičnim izpuščajem;
Study V87P3 21 days after 2nd dose N=30
Študija V87P3 21. dni po 2. odmerku N = 30
MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively.
A/turkey/Turkey/2005 v razponu od 10 % (2-27) do 39 % (32-46) in na stopnjo serokonverzije proti temu sevu med 10 % (2-27) in 36 % (29-43).
Visually inspect the suspension prior to administration.
Pred dajanjem cepivo vizualno preglejte.
Keep this vaccine out of the sight and reach of children.
Cepivo shranjujte nedosegljivo otrokom.
MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions.
Rezultati testov MN proti homolognemu sevu A/turkey/Turkey/1/2005 kažejo na stopnjo serokonverzije 66,67 % pri zdravih odraslih osebah ter od 33,57 % do 54,14 % pri odraslih osebah z zmanjšanim imunskim odzivom ali osnovnimi bolezenskimi stanji.
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182
Študija V87P11 A/turkey/Turkey/1/2005 21 dni po 2. odmerku N = 182
Study V87P13 21 days after 2nd dose N=197
Študija V87P13 21. dni po 2. odmerku N = 197
Elderly (61-79 years)a
Starejši (61-79 let)
MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
94-100), stopnjo serokonverzije v razponu od 97 % (95-odstotni IZ: 91-99) do 99 % (95-odstotni IZ: 96-100) in GMR v razponu od 29 (95-odstotni IZ: 25-35) do 50 (95-odstotni IZ: 44-58).
Reporting of suspected adverse reactions
vsi drugi neželeni učinki Poročanje o domnevnih neželenih učinkih
These side effects may occur with AFLUNOV.
Ti neželeni učinki se lahko pojavijo s cepivom AFLUNOV.
Like all medicines, AFLUNOV can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa cepiva ima lahko tudi cepivo AFLUNOV neželene učinke, ki pa se ne pojavijo pri vseh ljudeh.
• Hardening of the skin at the injection site
• bolečina na mestu injiciranja, • otrdelost kože na mestu injiciranja,
There is no information on administration of AFLUNOV with noninfluenza vaccines.
Ni podatkov o dajanju cepiva AFLUNOV s cepivi, ki niso namenjena proti gripi.
- Keep this leaflet.
ga zavrzite.
assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4).
V obeh študijah (V87_25 in V87_26) nižje ravni protiteles (izmerjene s testi HI, SRH in MN) in znižane stopnje serozaščite pri odraslih in starejših osebah (starih ≥ 61 let) z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom kažejo na to, da cepivo AFLUNOV pri teh osebah morda ne vzpostavi enake stopnje zaščite proti sevu A/H5N1 kot pri zdravih odraslih osebah (glejte poglavje 4.4).
How AFLUNOV is given
Kako se daje cepivo AFLUNOV
Baseline Serostatus
OVOJNINA ZA BRIZGE
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004, izmerjeno s testi SRH, so bili kot sledi:
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows:
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004 in na H5N1 A/turkey/Turkey/1/2005 pri odraslih, izmerjeno s testom SRH, so bili, kot sledi:
Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Geometrijska sredina površine*, stopnja serozaščite*, stopnja serokonverzije* in faktor serokonverzije** za protitelo proti HA na H5N1 A/turkey/Turkey/1/2005, izmerjeni s testi SRH 21 dni po 2. odmerku, so bili naslednji:
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na sev H5N1 A/turkey/Turkey/1/2005 po 2. odmerku pri odraslih, starih od 18 do 60 let, izmerjeno s testoma SRH in HI, so bili, kot sledi:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Talk to your doctor or nurse before having this vaccine
Pred cepljenjem s tem cepivom se posvetujte z zdravnikom ali medicinsko sestro.
Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population.
Pri teh bolnikih so zelo pogosto poročali o siljenju na bruhanje, bolečinah v sklepih, driski in izgubi apetita.
Adults from 18 onwards:
Odrasli, stari 18 let ali več:
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na H5N1 A/Indonesia/5/2005 in A/Vietnam/1194/2004 po 2. odmerku pri odraslih (18-60 let) in starejših (≥ 61 let), izmerjeno s testoma SRH in HI, so bili, kot sledi:
Influenza like illness
trepetanje gripi podobna bolezen anafilaksa
Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
S 3-tedenskim presledkom so 156 zdravih odraslih oseb cepili z dvema odmerkoma cepiva AFLUNOV.
Study V87P2 Adults booster after 2nd dose
Študija V87P2 odrasli obnovitev po 2. odmerku
• Nausea
• krči,
°° GMRs of HI
** GMR za SRH
Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of AFLUNOV, a protective immune response may not be elicited in all vaccinees.
Na podlagi humoralnih imunskih odzivov na cepilni sev A/turkey/Turkey/1/2005 po dveh odmerkih cepiva
Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd
Ime in naslov izdelovalcev biološke učinkovine
Study V87P1 Elderly booster after 2nd dose
Študija V87P1 starejše osebe obnovitev po 2. odmerku
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Študija V87P11 A/turkey/Turkey/1/2005 21. dni po 2. odmerku N = 132
• Injection site redness
• pordečeno mesto injiciranja,
Study V87P1 Adults booster after 2nd dose
Študija V87P1 odrasli obnovitev po 2. odmerku
A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
faze (V87P1) s cepivom AFLUNOV (A/Vietnam/1194/2004).
Adults (19- 60 years)a
Odrasli (19-60 let)
Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
V87_26, z odraslimi (18-60 let) in starejšimi osebami (≥ 61 let), ki so bile zdrave ali pa so imele osnovna bolezenska stanja ali oslabljen imunski odziv.
Nervous system disorders
Bolezni živčevja glavobol konvulzije
Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue
rdečina na mestu injiciranja, utrujenost ekhimoza na mestu injiciranja, zvišana telesna temperatura, splošno slabo počutje,
Medical conditions
UPORABO ZDRAVILA
Seroprotection rate (95%CI) ° Seroconversion rate (95%CI) ° Seroconversion factor (95%CI) °°
(95-odstotni IZ)° Stopnja serokonverzije (95-odstotni IZ)° Faktor serokonverzije (95-odstotni IZ)°°
(A/Vietnam/1194/2004) dose, all vaccine schedule groups after 3 weeks from the 2nd vaccination achieved high levels of antibodies as evaluated with SRH.
starih 18 do 60 let, kjer je drugi odmerek sledil 1, 2, 3 ali 6 tednov po prvem odmerku cepiva AFLUNOV (A/Vietnam/1194/2004), so vsi režimi cepljenja po 3. tednih po 2. cepljenju dosegli visoke ravni protiteles, ocenjene s SRH.
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Oslabelost mišic, bolečine v okončinah
Immunocompromised
Z oslabljenim imunskim odzivom
Non-clinical data obtained with AFLUNOV and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
MF59C.1, na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalnega prenašanja,
Adults (20- 60 years)a
Odrasli (20-60 le t)*
Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Prebavne težave, kot so navzea, bruhanje, bolečine v trebuhu in driska
MARKETING AUTHORISATION HOLDER
Spremljanje v obdobju trženja
How to store AFLUNOV
Shranjevanje cepiva AFLUNOV
Anti-HA antibody Study V87P12 21 days after 2nd dose N=60
Študija V87P12 21. dni po 2. odmerku N = 60
The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV.
imenovanim Focetria H1N1v, ki je podobno cepivu AFLUNOV.
Suspension for injection in pre-filled syringe.
suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno-bela tekočina
Other rare side effects observed after routine use:
Drugi redki neželeni učinki, ki so jih opazili po rutinski uporabi: Spodaj našteti neželeni učinki so se pojavili v dneh ali tednih po cepljenju z drugim cepivom,
a actual age range of population enrolled * Seroprotection: SRH area≥25 mm2
* izmerjeno s testom SRH; serozaščita: površina SRH ≥ 25 mm2; serokonverzija: površina SRH
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
• če ste imeli kakršno koli alergijsko reakcijo, ki ni bila nenadna, življenje ogrožajoča, na katero koli sestavino cepiva, na jajčne in piščančje beljakovine, na ovalbumin, formaldehid,
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)***
(95-% IZ)* Stopnja serokonverzije (95-% IZ)* Faktor serokonverzije (95-% IZ)**
The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:
Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom AFLUNOV v kliničnih študijah: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov):
Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Ime in naslov izdelovalca, odgovornega za sproščanje serij
There are no data with AFLUNOV using the subcutaneous route of administration.
Podatkov o subkutani poti uporabe cepiva AFLUNOV ni.
MedDRA System Organ class Very common
Organski sistem po MedDRA
Clinical trials with AFLUNOV have been conducted with either the former A/Vietnam/1194/2004 (H5N1) (clade 1) or the current A/turkey/Turkey/1/2005 (H5NI) vaccine strain (clade 2.2.1).
A/Vietnam/1194/2004 (H5N1) ali sedanjim sevom A/turkey/Turkey/1/2005 (H5N1) (gruča 2.2.1).
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 66
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 128
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 69
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=149
Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 149
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Imetnik dovoljenja za promet z zdravilom in izdelovalec: Imetnik dovoljenja za promet z zdravilom
• Injection site swelling
• oteklo mesto injiciranja,
Posology
sistemom
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a
Študija V87P1 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 84
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Študija V87P13 A/Vietnam/1194/2004 21. dni po 2. odmerku N = 143
* measured by SRH assay seroprotection: SRH area ≥25 mm2, seroconversion: SRH area ≥25 mm2 for subjects with a baseline SRH area ≤4 mm2 or a minimum 50% increase in SRH area for subjects with >4 mm2.
≥ 25 mm2 za osebe s površino SRH ≤ 4 mm2 ob izhodišču ali z vsaj 50 % povečanjem površine
Immune system disorders
Limfadenopatija Bolezni imunskega sistema
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b
Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 210
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=197
Študija V87P13 A/Vietnam/1194/2004 21. dan po 2. odmerku N = 197
Cardiac disorders Palpitation, tachycardia.
Palpitacije, tahikardija Bolezni dihal Kašelj
• Vomiting
• mravljinčenje,
Immunocompromised N=139
sistemom N = 139
They should not be used during pregnancy and breastfeeding.
Ne smejo se uporabljati med nosečnostjo in dojenjem.
This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njihovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
Castor oil medicines should only be used in adults, and should not be taken for longer than one week without medical supervision.
Zdravila, ki vsebujejo ricinusovo olje, se smejo uporabljati samo pri odraslih in se brez zdravniškega nadzora ne smejo uporabljati več kot en teden.
This means that the oil is extracted from the seeds by crushing and pressing them without heating.
To pomeni, da se olje ekstrahira iz semen tako, da se semena brez segrevanja zdrobijo in stisnejo.
Castor oil EMA/108531/2016
Ricinusovo olje EMA/108531/2016
This summary is not intended to provide practical advice on how to use medicines containing castor oil.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo ricinusovo olje.
Castor oil is the common name for the oil obtained from the seeds of the plant Ricinus communis L. The HMPC conclusions only cover castor oil preparations which are obtained by ‘cold expression' of the seeds.
Ricinusovo olje je splošno ime za olje, pridobljeno iz semen rastline Ricinus communis L. Zaključki odbora HMPC zajemajo samo pripravke z ricinusovim oljem, ki se pridobivajo s „hladnim iztiskanjem“ semen.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of castor oil.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo ricinusovega olja.
Herbal medicines containing these castor oil preparations are usually available in solid or liquid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo te pripravke z ricinusovim oljem, so navadno na voljo v trdni ali tekoči obliki za jemanje skozi usta.
What is castor oil?
Kaj je ricinusovo olje?
Castor oil medicines should not be taken in case of obstruction or narrowing of the gut, atony (loss of normal movement in the gut muscle), appendicitis (inflammation of the appendix, a small organ connected to the bowel), inflammatory diseases of the colon (the lower part of the bowel), unexplained abdominal pain and severe dehydration.
Zdravila, ki vsebujejo ricinusovo olje, se ne smejo uporabljati pri črevesni zapori ali zožitvi, atoniji (izgubi normalnega gibanja črevesnih mišic), apendicitisu (vnetju slepiča, majhnega organa, povezanega s črevesjem), vnetni bolezni debelega črevesa (spodnjega dela črevesa), nepojasnjeni bolečini v trebuhu in hudi dehidraciji.
Further information on the risks associated with castor oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo ricinusovo olje, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
How does castor oil work as a medicine?
Kako ricinusovo olje deluje kot zdravilo?
In its assessment, the HMPC considered two clinical studies which showed a laxative effect for castor oil medicines in constipated patients.
V svoji oceni je odbor HMPC upošteval dve klinični študiji, ki sta pokazali, da imajo zdravila, ki vsebujejo ricinusovo olje, pri bolnikih z zaprtjem odvajalni učinek.
In one of the studies the effects of castor oil capsules were similar to those of senna capsules (another herbal preparation commonly used to treat constipation).
V eni od študij so bili učinki ricinusovega olja podobni učinkom kapsul sene (drugega pripravka rastlinskega izvora, ki se pogosto uporablja za zdravljenje zaprtosti).
This increases the water content of stools, making them softer and easier to pass.
S tem se poveča vsebnost vode v blatu, zato blato postane mehkejše in se lažje odvaja.
The HMPC conclusions on the use of these castor oil medicines as laxatives are based on their ‘wellestablished use'.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo ricinusovo olje, kot odvajal temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“.
These include nausea, vomiting abdominal (belly) pain and severe diarrhoea.
Ti vključujejo slabost, bruhanje, bolečine v trebuhu in hudo drisko.
Castor oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Pripravki z ricinusovim oljem so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.