natgillin/translations-raw huggingface dataset:
Metabolisme Calciumfolinat er en racemat hvor L- formen (L- formyltetrahydrofolat, L- 5- formyl- THF) er den aktive enantiomer.
Metabolism Calcium folinate is a racemate where the L-form (L-5-formyl-tetrahydrofolate, L-5-formyl-THF), is the active enantiomer.
Hovedmetabolitten af folininsyre er 5- methyltetrahydrofolinsyre (5- methyl- THF) som hovedsalig produceres i leveren og intestinale mucosa.
The major metabolic product of folinic acid is 5-methyl-tetrahydrofolic acid (5-methyl-THF) which is predominantly produced in the liver and intestinal mucosa.
Distribution Distributionsvolumet for folininsyre er ikke kendt.
Distribution The distribution volume of folinic acid is not known.
Maksimal serumkoncentration af udgangsstoffet (D/ L- 5- formyl- tetrahydrofolinsyre, folininsyre) opnås 10 minutter efter i. v. administration.
Peak serum levels of the parent substance (D/ L-5-formyl-tetrahydrofolic acid, folinic acid) are reached 10 minutes after i. v. administration.
AUC for L- 5- formyl- THF og 5- methyl- THF var 28, 4 ± 5, 3 mg. min/ l og 129 ± 112 mg. min/ l efter en dose på 25 mg.
AUC for L-5-formyl-THF and 5-methyl-THF were 28.4±3.5 mg. min/ l and 129±112 mg. min/ l after a dose of 25 mg.
Den inaktive D- isomer er tilstede i højere koncentrationer end L- 5 - formyltetrahydrofolat.
The inactive D-isomer is present in higher concentration than L-5-formyl- tetrahydrofolate.
Elinimation Elimineringshalveringstiden er henholdsvis 32- 35 minutter for den aktive L- form og 352- 485 min. for den inaktive D- form.
Elimination The elimination half-life is 32 - 35 minutes for the active L-form and 352 - 485 minutes for the inactive D-form, respectively.
6 timer (ved intravenøs og intramuskulær administration).
The total terminal half-life of the active metabolites is about 6 hours (after intravenous and intramuscular administration).
Udskillelse 80- 90% udskilles via urinen (inaktive 5 - og 10- formyltetrahydrofolatmetabolitter), mens 5- 8% udskilles via fæces.
Excretion 80-90% with the urine (5- and 10-formyl-tetrahydrofolates inactive metabolites), 5-8% with the faeces.
Der findes ingen relevante prækliniske data med hensyn til klinisk sikkerhed, udover det som er nævnt i andre dele af produktresuméet.
5.3 Preclinical safety data EMEA/ CPMP/ 3736/ 03 18/ 21  EMEA 2003 There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.
(Implementeres nationalt)
(To be implemented nationally)
Der er rapporteret uforligelighed mellem injicerbare former af calciumfolinat og injicerbare former af droperiol, fluoruracil, foscarnet og methotrexat.
Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet and methotrexate.
Droperidol 1.
Droperidol 1.
Droperidol 1, 25 mg/ 0, 5 ml sammen med calciumfolinat 5 mg/ 0, 5 ml, umiddelbar udfældning ved direkte blanding i sprøjten i 5 minutter ved 25°C efterfulgt af 8 minutters centrifugering.
Droperidol 1.25 mg/ 0.5 ml with calcium folinate 5 mg/ 0.5 ml, immediate precipitation in direct admixture in syringe for 5 minutes at 25° C followed by 8 minutes of centrifugation.
Droperidol 2, 5 mg/ 0, 5 ml med calciumfolinat 10 mg/ 0, 5 ml, umiddelbar udfældning når lægemidlerne injiceres lige efter hinanden i et Y- stykke uden at skylle sidearmen imellem injektionerne.
Droperidol 2.5 mg/ 0.5 ml with calcium folinate 10 mg/ 0.5 ml, immediate precipitation when the drugs were injected sequentially into a Y-site without flushing the Y-side arm between injections.
Fluoruracil Calciumfolinat må ikke blandes i den samme infusion som 5- fluoruracil, da der kan dannes et præcipitat.
Fluorouracil Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
Fluoruracil 50 mg/ ml med calciumfolinat 20 mg/ ml sammen med eller foruden dextrose 5% i vand, har vist sig at være uforligeligt, blandet i forskellige mængder og opbevaret i beholdere af polyvinylklorid ved 4°C, 23°C eller 32°C.
Fluorouracil 50 mg/ ml with calcium folinate 20 mg/ ml, with or without dextrose 5% in water, has been shown to be incompatible when mixed in different amounts and stored at 4° C, 23° C, or 32° C in polyvinyl chloride containers.
Foskarnet Foscarnet 24 mg/ ml sammen med calciumfolinat 20 mg/ ml; dannelse af uklar, gullig opløsning er rapporteret.
Foscarnet Foscarnet 24 mg/ ml with calcium folinate 20 mg/ ml formation of a cloudy yellow solution reported.
6. 3 Opbevaring
Shelf life
Opbevares ved 2°C – 8°C (i køleskab).
Store at 2°C - 8°C (in a refrigerator).
Opbevares i den originale beholder beskyttet mod lys.
Store in original container to protect from light.
(Se bilag 1 - bestemmes nationalt)
(See Annex I – To be implemented nationally)
6. 6 Eventuelle instruktioner vedrørende anvendelse og håndtering samt bortskaffelse
6.6 Instructions for use and handling and disposal
Efter rekonstruktion og før administration, bør calciumfolinat inspiceres visuelt.
Prior to administration, calcium folinate should be inspected visually.
Opløsningen til injektion eller infusionen bør være en klar gullig opløsning.
The solution for injection or infusion should be a clear and yellowish solution.
Hvis opløsningen er uklar, eller der observeres partikler i den, skal opløsningen kasseres.
If cloudy in appearance or particles are observed, the solution should be discarded.
Calciumfolinat opløsning til injektion eller infusion er kun til engangsbrug.
Calcium folinate solution for injection or infusion is intended only EMEA/ CPMP/ 3736/ 03 19/ 21  EMEA 2003 for single use.
Enhver ubrugt opløsning bør destrueres i henhold til lokale gældende krav.
Any unused portion of the solution should be disposed of in accordance with the local requirements.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN EMEA/ CPMP/ 3736/ 03 19/ 20 EMEA 2003 (Se bilag 1 – implementeres nationalt)
(See Annex I – To be implemented nationally)
EMEA/ CPMP/ 3736/ 03 20/ 20 EMEA 2003
EMEA/ CPMP/ 3736/ 03 20/ 21  EMEA 2003 EMEA/ CPMP/ 3736/ 03 21/ 21  EMEA 2003
LISTE MED NAVNE, LÆGEMIDDELFORM, STYRKEN PÅ LÆGEMIDDELPRODUKTET, ADMINISTRATIONSVEJ, ANSØGERE / INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
(Påfundet) navn
(Invented) Name
1103 Budapest Gyömrői út 19- 21 Ungarn
Hungary
10 mg / 5 mg
10 mg/ 5 mg
tabletter oral anvendelse
oral use
tabletter
tablets
1103 Budapest Gyömrői út 19- 21 Ungarn.
Hungary.
1 Navn afventer godkendelse
1 Name approval pending
Lisonorm 10mg/ 5mg
Lisonorm 10mg/ 5mg
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
Lisonorm er en ny fastdosis kombination, der indeholder 10 mg lisinopril (en ACE- hæmmer) og 5 mg amlodipin (en calcium- antagonist), indiceret til patienter med et blodtryk, som er tilstrækkeligt reguleret med lisinopril og amlodipin indgivet samtidigt ved samme dosisniveau.
Lisonorm is a new fixed-dose combination containing 10mg lisinopril (an ACE inhibitor) and 5mg amlodipine (a calcium antagonist), indicated for patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
I henhold til myndighedskravene (CHMP/ EWP/ 191583/ 2005) skal der foreligge en formel dokumentation for bioækvivalens, bevis for en bred terapeutisk erfaring og et tilstrækkeligt dokumenteret benefit/ risk- forhold for nye fastdosiskombinationsprodukter, som påberåber sig substitutionsindikation.
In line with the regulatory requirements (CHMP/ EWP/ 191583/ 2005), a formal proof of bioequivalence, evidence of a wide therapeutic experience, and an adequately established benefit/ risk ratio should be demonstrated for new fixed dose combination products claiming substitution indication.
67289) tillod ikke en fuldstændig vurdering af benefit/ risk - forholdet.
For Lisonorm (new lisinopril 10mg/ amlodipine 5mg combination), a positive benefit/ risk ratio had not been established given that the initial bioequivalence study submitted was not conducted with the appropriate control, and that preliminary results of a new bioequivalence study (No.67289) did not allow a full assessment of the benefit risk ratio.
67289) med henblik på at undersøge bioækvivalensen af LISONORM FORTE (fast kombination af amlodipin 10 mg og lisinopril 20 mg), samtidig administration af NORVASC 10 mg (indeholdende amlodipin 10 mg) og PRINIVIL 20 mg (indeholdende lisinopril 20 mg) og LISONORM (fast kombination af amlodipin 5 mg og lisinopril 10 mg) under fastende betingelser.
Therefore, the Applicant acknowledged the limitations arising from the product selection in the initial pivotal BE study and performed a study (Protocol No 67289) to investigate bioequivalence of LISONORM FORTE (fixed-combination of amlodipine 10 mg and lisinopril 20 mg), co-administration of NORVASC 10 mg (containing amlodipine 10 mg) and PRINIVIL 20 mg (containing lisinopril 20 mg), and LISONORM (fixed-combination of amlodipine 5 mg and lisinopril 10 mg) under fasting conditions.
De farmakokinetiske parametre blev beregnet for amlodipin og lisinopril ved hjælp af Bioequiv 3. 5 softwaren under anvendelse af en modeluafhængig metode.
Pharmacokinetic parameters were calculated for amlodipine and lisinopril by the means of Bioequiv 3.5 software using a model independent approach.
Ansøgeren fremlagde disse farmakokinetiske resultater for amlodipin og lisinopril sammen med semi- logaritmiske gennemsnitstidskurver for plasmakoncentrationen.
The Applicant provided these pharmacokinetic results for amlodipine and lisinopril along with semi-logarithmic mean plasma concentration-time curves.
Også de geometriske gennemsnitsforhold, 90% konfidensintervaller og tilsvarende intra- individuelle CV’ er for Cmax, AUC0- t og AUC0- ∞ for amlodipin og lisinopril blev fremlagt.
The geometric mean ratios, 90% confidence intervals and corresponding intra-individual CVs for Cmax, AUC0-t and AUC0-∞ for amlodipine and lisinopril were also presented.
Alt i alt anså CHMP, at ansøgeren havde fremlagt tilstrækkeligt svar ved at dokumentere resultaterne af en yderligere undersøgelse, BES Nr. 67289, og havde fremlagt formel dokumentation for bioækvivalens.
Overall, the CHMP considered that the applicant had responded adequately by providing the results of an additional study, BES No.67289, and had demonstrated formal proof of bioequivalence.
LC- MS/ MS- metoder blev valideret for analyse af begge præparater, og prøvestabiliteten blev dokumenteret over prøveopbevaringsperioden.
LC-MS/ MS methods were validated for analysis of both compounds, and the stability of the samples was documented over the period of sample storage.
De 90% konfidensintervaller beregnet for AUC( 0- t), AUC( 0- inf) og Cmax lå inden for området 0, 8- 1, 25 for begge komponenter (lisinopril og amlodipin).
The 90% confidence intervals calculated for AUC(0-t), AUC(0-inf) and Cmax were within the range of 0.8-1.25 for both components (lisinopril and amlodipine).
5 Med hensyn til sikkerhed var der 3 frafaldne undersøgelsespersoner.
With regards to safety, there were 3 drop-out subjects.
Der blev indberettet i alt 96 post - dosis bivirkninger af 35 af de 48 undersøgelsespersoner, der fik mindst en dosis af undersøgelseslægemidlet.
As expected in this type of
Som forventet ved denne type lægemiddel var hovedpine den almindeligst rapporterede bivirkning.
5 medicinal product, headache was the most commonly reported adverse event.
Derudover var der en høj forekomst af forlænget QT- interval, som observeredes hos 16, 7% af undersøgelsespersonerne (n=8).
Additionally, there was a high incidence of QT prolongation observed in 16.7% subjects (n=8).
Forekomsten af forlængelse af QT - interval var tilsvarende ved alle 3 forskellige behandlingsmuligheder, og der var ingen statistisk signifikante forskelle mellem prædosis og postdosis QTc- værdier.
The appearance of QT prolongation was similar in all 3 different treatment options, and there were no statistically significant differences between pre- dose and post-dose QTc values.
- Ansøgeren har fremlagt resultaterne af en bioækvivalensundersøgelse, nr.
- the Applicant has submitted a bioequivalence study, No.
67289, som viser, at
67289, which shows that the test product induces
undersøgelseslægemidlet giver PK- profiler for amlodipin og lisinopril i fastdosiskombination, som er sammenlignelige med værdierne for referencelægemidlerne (monokomponenter).
comparable PK profiles for amlodipine and lisinopril in the fixed dose combination to those of the reference products (monocomponents).
- Undersøgelseslægemidlets sikkerhedsprofil udviser ikke nogen forskelle med hensyn til bivirkninger
- the safety profile of the test product shows no differences with respect to adverse events associated with the
i forbindelse med administration af amlodipin og lisinopril sammenlignet med hver af referencebehandlingerne.
administration of amlodipine and lisinopril compared to either reference treatments.
7 PRODUKTRESUME
7 ANNEX III
Lisonorm og relaterede navne (se bilag I) 10/ 5 mg tabletter [Se Bilag I – Skal udfærdiges nationalt]
Lisonorm and associated names (see Annex I) 10/ 5 mg tablets [See Annex I - To be completed nationally]
Hvid eller off- white, rund, flad tablet med affaset kant og delekærv på den ene side med indgraveringen “ A+L ” på den anden side.
White or off-white, round, flat, bevel-edged tablet with a score line on one side and with an engraving „ A+L” on the reverse side.
Patienter med nyreinsufficiens For at finde den optimale startdosis og vedligeholdelsesdosis til patienter med nyreinsufficiens, skal patienterne titreres individuelt med de enkelte indholdsstoffer i lisinopril og amlodipin.
Patients with renal impairment To find the optimal starting dose and maintenance dose of patients with renal impairment, the patients should be individually titrated using the individual components of lisinopril and amlodipine.
Lisonorm er kun indiceret til patienter, hvor den optimale vedligeholdelsesdosis af lisinopril og amlodipin er blevet titreret til henholdsvis 10 mg og 5 mg.
Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively.
Nyrefunktionen samt serum- kalium og - natriumniveauerne skal monitoreres under behandling med Lisonorm.
Renal function, serum potassium and sodium levels should be monitored during therapy with Lisonorm.
Patienter med leverinsufficiens Udskillelsen af amlodipin kan være forlænget hos patienter med nedsat leverfunktion.
Patients with hepatic impairment The elimination of amlodipine may be prolonged in patients with impaired liver function.
Børn og unge Lisonorm bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og effekt.
Children and adolescents Lisonorm is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Ældre (> 65 år) Ved kliniske undersøgelser var der ingen aldersrelaterede ændringer i effekt - eller sikkerhedsprofilen for amlodipin eller lisinopril.
Elderly (> 65 years)
For at finde frem til den optimale vedligeholdelsesdosis for ældre
10 In clinical studies, there was no age-related change in the efficacy or safety profile of amlodipine or lisinopril.
9 patienter, bør de titreres individuelt med en fri kombination af lisinopril og amlodipin.
To find the optimal maintenance dose for elderly patients they should be individually titrated using the free combination of lisinopril and amlodipine.
Lisonorm er kun indiceret til patienter hvor den optimale vedligeholdelsesdosis af lisinopril og amlodipin er blevet titreret til henholdsvis 10 mg og 5 mg.
Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively (see section 4.4).
• Overfølsomhed over for lisinopril eller noget andet angiotensinkonverterende enzym (ACE) - hæmmer. • Overfølsomhed over for amlodipin eller andre dihydropyridin- derivater. • Overfølsomhed over for ét eller flere af hjælpestofferne. • Alvorlig hypotension. • Angioødem med relation til tidligere ACE- hæmmerterapi i anamnesen. • Hereditært eller idiopatisk angioødem (se punkt 4. 4). • Hæmodynamisk signifikant obstruktion i udløbskanalen fra venstre ventrikel (aortastenose, hypertrofisk kardiomyopati), mitralstenose eller kardiogent chok. • Hjertestop efter akut myokardieinfarkt (i de første 28 dage). • Ustabil angina pectoris (med undtagelse af Prinzmetals angina). • Graviditet og amning (se punkt 4. 6).
• Hypersensitivity to lisinopril or to any other angiotensin converting enzyme (ACE) inhibitor. • Hypersensitivity to amlodipine or to any other dihydropyridine derivatives. • Hypersensitivity to any of the excipients. • Severe hypotension. • A history of angioedema relating to previous ACE inhibitor therapy. • Hereditary or idiopathic angioedema (see section 4.4). • Haemodynamically significant obstruction in the outflow tract of the left ventricle (aortic stenosis, hypertrophic cardiomyopathy), mitral stenosis or cardiogenic shock. • Heart failure after acute myocardial infarction (during the first 28 days). • Unstable angina pectoris (excluding Prinzmetal’ s angina). • Pregnancy and lactation (see section 4.6).
Symptomatisk hypotension Substantielt blodtryksfald og derfor symptomatisk hypotension kan forekomme hos patienter med volumen - og/ eller natriummangel som følge af behandling med diuretikum, væsketab af anden oprindelse, såsom for kraftig diaforese, længere tids opkastning og/ eller diarré (se punkt 4. 2).
Symptomatic hypotension Substantial decrease in blood pressure and hence symptomatic hypotension can occur in patients with volume and/ or sodium depletion resulting from diuretic therapy, fluid loss of other origin such as excessive diaphoresis, prolonged vomiting and/ or diarrhoea (see section 4.2).
Natrium - og/ eller volumenmangel skal helst korrigeres, før behandling med Lisonorm påbegyndes.
Preferably, sodium and/ or volume depletion should be corrected before treatment with Lisonorm is started.
Aorta - og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved alle vasodilatorer skal Lisonorm administreres med forsigtighed til patienter med obstruktion i udstrømningskanalen fra venstre ventrikel samt med mitralklapstenose.
Aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy As with all vasodilators, Lisonorm should be administered with caution to patients with obstruction in the outflow tract of the left ventricle and with stenosis of mitral valve.
Nedsat nyrefunktion Visse hypertensive patienter uden nogen åbenbar præeksisterende vaskulær nyrelidelse har udviklet forhøjet blodurea og serumkreatinin, i reglen mindre og forbigående, specielt når der er indgivet angiotensinkonverterende enzymhæmmere samtidigt med et diuretikum.
Renal function impairment Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when angiotensin converting enzyme inhibitors has been given concomitantly with a diuretic.
Hos visse patienter med bilateral nyrearteriestenose eller med stenose i arterien til en enkelt nyre, der er blevet behandlet med ACE- hæmmere, er der observeret forhøjet blodurea og serumkreatinin, i reglen ved seponering af behandlingen.
In some patients with bilateral renal artery stenosis or with a stenosis of the artery to a solitary kidney, who have been treated with angiotensin converting enzyme inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.
Dosisreduktion og/ eller seponering af diuretikummet kan også være påkrævet.
Dose reduction and/ or discontinuation of the diuretic may also be required.
Angioødem Angioødem i ansigt, ekstremiteter, læber, tunge, glottis og/ eller larynx er blevet indberettet hos patienter behandlet med ACE- hæmmere, herunder lisinopril.
11 Angioedema of the face, extremities, lips, tongue, glottis and/ or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including lisinopril.
Alligevel kan antihistaminer være nyttige til lindring af symptomerne.
Where swelling is confined to the face, lips and extremities, it usually resolves spontaneously; nevertheless, antihistamines may be useful in relieving symptoms.
Passende foranstaltninger omfatter subkutan administration af 0, 3- 0, 5 mg adrenalin, epinephrin eller langsom intravenøs administration af 0, 1 mg adrenalin efterfulgt af glucocorticoider og antihistaminer med samtidig monitorering af de vitale funktioner.
Appropriate measures include the subcutaneous administration of 0.3-0.5 mg adrenaline epinephrine or the slow intravenous administration of 0.1 mg adrenaline, followed by glucocorticoids and antihistamines, with simultaneous monitoring of vital functions.
ACE- hæmmere forårsager hyppigere angioødem hos farvede patienter end hos ikke- farvede patienter.
Angiotensin converting enzyme inhibitors cause a higher rate of angioedema in black patients than in non- black patients.
Intestinalt ødem er indberettet i sjældne tilfælde hos patienter behandlet med ACE- hæmmere.
Intestinal oedema has been reported rarely in patients treated with ACE inhibitors.
I visse tilfælde var der intet forudgående facialt angioødem, og C- 1 esteraseniveauerne var normale.
These patients presented with abdominal pain (with or without nausea and vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal.
Angioødemet blev diagnosticeret via procedurer, der omfattede CT- scanning eller ultralyd eller ved kirurgisk indgreb, og symptomerne ophørte efter, at ACE- hæmmeren var seponeret.
The angioedema was diagnosed by procedures including CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor.
Intestinalt angioødem bør medtages i den differentielle diagnosticering af patienter på ACE- hæmmere, der møder med abdominale smerter.
Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Anafylaktoide reaktioner hos hæmodialyserede patienter Anafylaktisk chok er indberettet hos patienter dialyseret med polyakrylnitril (f. eks.
Anaphylactoid reactions in haemodialysis patients Anaphylactic shock has been reported in patients dialysed with polyacrylonitrile (e. g.
AN 69) membran og samtidig behandling med en ACE- hæmmer, derfor bør denne kombination undgås.
AN 69) membrane and treated concomitantly with an ACE inhibitor, therefore, this combination must be avoided.
Anafylaktoide reaktioner under lav- densitets lipoprotein - (LDL) aferese Det er sket i sjældne tilfælde, at patienter, der fik ACE- hæmmere under lav- densitets lipoprotein - (LDL) aferese med dextransulfat har oplevet livstruende anafylaktoide reaktioner.
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis Rarely, patients receiving ACE inhibitors during low-density lipoproteins (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions.
Disse reaktioner blev undgået ved en temporær seponering af ACE- hæmmer- behandlingen forud for hver aferese.
These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Desensibilisering over for bi - / hvepsegift Sommetider har patienter, der fik ACE- hæmmere under desensibilisering med Hymenoptera- gifte (f. eks. hvepse eller bier), oplevet anafylaktoide reaktioner.
Bee/ wasp venom desensitization Occasionally, patients receiving ACE inhibitors during desensitization with Hymenoptera (e. g. wasp, bee) venom have experienced anaphylactoid reactions.
Disse livstruende reaktioner kan undgås ved midlertidig seponering af ACE- hæmmer- behandlingen.
These life-threatening reactions can be avoided by temporary withdrawal of ACE inhibitor therapy.