natgillin/translations-raw huggingface dataset:
Sammenligning mellem overlevelseskurverne for de to behandlingsformer ved hjælp af log rank test viste en statistisk signifikant forskel mellem kurverne for de to grupper i ITT- populationen (p=0, 0014), hvilket viser en signifikant forsinkelse i progressionen til cancer.
Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014), indicating a significant delay in the progression to cancer.
Natriumporfimers farmakokinetik er blevet undersøgt hos 12 patienter med endobronchial cancer og 23 raske forsøgspersoner (11 mænd og 12 kvinder), som fik indgivet 2 mg/ kg natriumporfimer ved langsom intravenøs injektion.
11 The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/ kg porfimer sodium through slow intravenous injection.
Hos patienterne var den gennemsnitlige højeste plasmakoncentration (Cmax) 79, 6 μg/ ml (CV 61%, område 39- 222); mens Cmax hos de frivillige forsøgspersoner var 40 μg/ ml og AUCinf var 2. 400 μg/ h/ ml.
In patients, the mean peak plasma concentration (Cmax) was 79.6 μ g/ ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μ g/ ml and AUCinf was 2400 μ g/ h/ ml.
Fordeling In vitro- binding af natriumporfimer til humant serumprotein er omkring 90% og uafhængig af koncentrationen mellem 20 og 100 μg/ ml.
Distribution In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μ g/ ml.
Elimination Natriumporfimer cleares langsomt fra kroppen med en gennemsnitlig CLT på 0, 859 ml/ h/ kg (CV 53%) hos patienter.
Elimination Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/ h/ kg (CV 53%) in patients.
Serumhenfaldet var bi- eksponentielt med en langsom fordelingsfase og en meget lang eliminationsfase, der startede 24 timer efter injektion.
The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
Den gennemsnitlige halveringstid (t½) var 21, 5 dage (CV 26%, område 264- 672) hos patienter og 17 dage hos frivillige forsøgspersoner.
The mean elimination half-life (t1/ 2) was 21.5 days (CV 26%, range 264-672) in patients and 17 days in volunteers.
4. 2, 4. 3 og 4. 4).
Special populations The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated (see sections 4.2, 4.3 and 4.4).
11 Kønnet har ingen indvirkning på farmakokinetiske parametre undtagen tmax, som var cirka 1, 5 timer for kvinder og 0, 17 timer for mænd.
Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
På tidspunktet for den tilsigtede fotoaktivering 40- 50 timer efter injektion var de farmakokinetiske profiler for natriumporfimer hos mænd og kvinder meget ens.
At the time of intended photoactivation 40-50 hours after injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar.
Med lysaktivering var natriumporfimer mutagent i visse in- vitro test.
With light activation, porfimer sodium was mutagenic in some in-vitro tests.
I disse studier forekom foetotoksicitet, men ikke teratogenicitet, hos rotter og kaniner kun ved evaluerede intravenøse doser (større end eller lig med 4 mg/ kg) og ved større hyppighed (dagligt) i sammenligning med klinisk anvendelse.
In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/ kg) and at greater frequency (daily) compared in the clinical use.
Prækliniske studier viser, at udskillelsen af natriumporfimer- bestanddele primært foregår via fæces.
Preclinical studies indicate that the excretion of porfimer sodium components occurs primarily via the faecal route.
Saltsyre (til pH- justering) Natriumhydroxyd (til pH- justering)
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Efter rekonstitution: anvendes straks (inden for 3 timer) Efter rekonstitution skal PhotoBarr anvendes straks (inden for 3 timer) og beskyttes mod lys.
After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected from light.
Hvis det ikke anvendes straks, er ibrugtagningens opbevaringstid og - forhold inden anvendelsen brugerens ansvar.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.
12 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
Instruktioner til rekonstitution PhotoBarr 15 mg hætteglas skal rekonstitueres med 6, 6 ml 5% glukose injektionsvæske, opløsning, hvilket giver en endelig natriumporfimerkoncentration på 2, 5 mg/ ml i injektionsvæsken, opløsning.
Instructions for reconstitution PhotoBarr 15 mg vial should be reconstituted with 6.6 ml of 5% glucose solution for injection resulting in a final porfimer sodium concentration of 2.5 mg/ ml in the solution for injection.
Der skal rekonstitueres et tilstrækkeligt antal hætteglas til at forsyne patienten med en dosis på 2 mg/ kg.
Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/ kg.
7, 5 kg yderligere legemsvægt.
A PhotoBarr 15 mg vial will be needed for every additional 7.5 kg body weight.
Spildt produkt og bortskaffelse Spildt PhotoBarr skal tørres op med en fugtig klud.
Spills and disposal Spills of PhotoBarr should be wiped up with a damp cloth.
Utilsigtet eksponering PhotoBarr er hverken et primært øjenirriterende middel eller et primært hudirriterende middel.
Accidental exposure PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Da PhotoBarr kan inducere lysfølsomhed, kan det dog irritere øjne og/ eller hud i nærvær af stærkt lys.
However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/ or skin irritant in the presence of bright light.
Det er vigtigt at undgå kontakt med øjne og hud under klargøringen og/ eller administrationen.
It is important to avoid contact with the eyes and skin during preparation and/ or administration.
Som ved enhver terapeutisk overdosering skal utilsigtet overeksponerede personer beskyttes mod stærkt lys.
As with therapeutic overdose, any accidentally overexposed person must be protected from bright light .’
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25. marts 2004 Dato for seneste fornyelse:
25 March 2004 Date of latest renewal:
Hvert hætteglas indeholder 75 mg natriumporfimer.
Each vial contains 75 mg porfimer sodium
Fotodynamisk terapi (PDT) med PhotoBarr er indiceret til fjernelse af højt differentieret dysplasi (HGD) hos patienter med Barretts øsofagus (BO)
- ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
5. 1).
This has to be balanced against the increased rate of stricture formation (see section 4.8 and section 5.1).
Progression til cancer var relateret til antallet af administrerede PDT- kure.
15 Progression to cancer was related to the number of PDT courses administered.
Patienter, der fik én PDT - kur havde en større risiko for progression til cancer end patienter, som fik to eller tre PDT- kure (50% mod henholdsvis 39% og.
Patients who received one course of PDT had a greater risk of progression to cancer than patients who received two or three courses of PDT (50% vs.
11%).
39% and 11% respectively)
6. 6.
Method of administration For instructions on reconstitution prior to administration, see section 6.6
14 Læger skal uddannes i brugen af PDT.
Physicians should be trained in the use of PDT.
Patienterne kan modtage en ny laserlysbestråling 96- 120 timer efter administration..
Patients may receive a second laser light application 96-120 hours after administration.
PhotoBarr skal administreres som en enkelt, langsom, intravenøs injektion over 3 til 5 minutter i en dosis på 2 mg/ kg legemsvægt.
PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes at 2 mg/ kg body weight.
Behandlet Barretts mucosa længde (cm)
Treated Barrett's Mucosa Length (cm)
Fiberoptik- diffusor størrelse (cm)
Fibre Optic Diffuser Size (cm)
Ballonvindue størrelse (cm)
Balloon Window Size (cm)
Lysdosis (J/ cm) = effekt- output fra diffusor (W) x behandlingstid (sek) diffusorlængde (cm)
The light dose (J/ cm)= power output from diffuser (W) x treatment time (sec) Diffuser length (cm)
Nødvendige fiberoptik effekt- output og behandlingstider til levering af 130 J/ cm af diffusorlængde ved hjælp af centreringsballonen
Fibre optic power outputs and treatment times required to deliver 130 J/ cm of diffuser length using the centring balloon
Ballonvindue længde (cm)
Required power
Diffusor - længde (cm)
length (cm)
Lysintensitet (mW/ cm)
intensity
Nødvendigt effekt- output fra diffusora (W)
output from a
Behand - lingstid (sek)
diffuser (W)
Behand - lingstid (min: sek)
(min: sec)
15 a Målt ved at nedsænke diffusoren i kuvetten i effektmåleren og langsomt øge lasereffekten.
As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Korte fiberoptik- diffusorer (< 2, 5 cm) skal bruges til at forbehandle noduli med 50 J/ cm diffusorlængde inden regulær ballonbehandling i den første laserlyssession eller til genbehandling af "oversprings" områder efter den første lyssession.
Short fibre optic diffusers (< 2.5 cm) are to be used to pretreat nodules with 50 J/ cm diffuser length prior to regular balloon treatment in the first laser light session or for the retreatment of "skip" areas after the first light session.
Til denne behandling bruges fiberoptik- diffusoren uden en ballon, og der skal anvendes en lysintensitet på 400 mW/ cm.
For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/ cm should be used.
Nødvendigt effekt - output fra diffusora (W)
output from diffusera (W)
Behandlingstid (sek)
(min: sec)
Behandlingstid (min: sek)
a
a Målt ved at nedsænke diffusoren i kuvetten i effektmåleren og langsomt øge lasereffekten.
As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Noduli skal forbehandles ved en lysdosis på 50 J/ cm af diffusorlængde med en kort (< 2, 5 cm) fiberoptik - diffusor placeret direkte mod noduli fulgt af anvendelse af standardballon som ovenfor beskrevet.
Nodules are to be pre-treated at a light doses of 50 J/ cm of diffuser length with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard balloon application as described above.
Ikke anvendelig
Light delivery devices NA
16 Patienterne kan modtage en ny PDT- kur efter mindst 90 dages forløb efter den initiale behandling; der bør gives indtil tre PDT- kure (med et mellemrum på mindst 90 dage mellem hver injektion) til et tidligere behandlet segment, der stadig frembyder HGD eller til et nyt segment, hvis det initiale Barretts segment var > 7 cm langt.
Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to three courses of PDT (each injection separated by a minimum of 90 days) should be given to a previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment was > 7 cm in length.
Særlig omhu med at sikre præcis dosering af PhotoBarr og/ eller lysdosis er afgørende, eftersom fejlberegning af enten medicinsk produkt eller lysdosis kan føre til en mindre effektiv behandling eller have en skadelig effekt på patienten.
Special care to ensure accurate PhotoBarr dosing and/ or light dose is crucial, since miscalculation of either medicinal product or light dose may lead to a less effective treatment or cause detrimental effect to the patient.
Særlige populationer Børn og unge PhotoBarr bør ikke anvendes til børn eller unge under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric patients PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety and efficacy.
Ældre patienter (> 65 år) Dosisændring baseret på alder er ikke nødvendig.
Elderly patients(≥ 65 years old) Dose modification based upon age is not required.
Nedsat nyrefunktion Indflydelsen af nyrepåvirkning på eksposition for natriumporfimer er ikke evalueret (se pkt.
Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated.
Overfølsomhed over for det aktive stof, andre porfyriner eller over for et eller flere af hjælpestofferne.
- Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
Porfyri.
- Porphyria.
Svær nyre - og/ eller leverfunktionsnedsættelse.
- Severe renal and/ or hepatic impairment.
Øsofagus - eller ventrikelvaricer eller patienter med øsofagusulcera > 1 cm i diameter.
- Oesophageal or gastric varices or patients with oesophageal ulcers > 1 cm in diameter.
Tracheo- øsofageal eller broncho- øsofageal fistel.
- Tracheo-oesophageal or broncho-oesophageal fistula.
Mistænkt erosion af større blodkar på grund af risikoen for massiv, potentielt fatal blødning.
- Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Fotodynamisk terapi med PhotoBarr er udelukkende undersøgt på patienter, som ikke lider af alvorlige medicinske tilstande såsom kongestiv hjerteinsufficiens i fremskredent stadium eller alvorlige lungetilstande, der kunne vanskeliggøre patientudvælgelsen til kirurgiske procedurer.
Photodynamic therapy with PhotoBarr has exclusively been studied in patients not suffering from severe medical conditions, such as
Patienter over 75 år har muligvis en højere risiko for respirationsrelaterede bivirkninger som pleuraekssudat og dyspnø.
Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea
17 Lunge - og hjertesygdomme Patienter med pulmonal eller kardial medicinsk sygdom eller en anamnese med en sådan sygdom skal behandles med forsigtighed.
Pulmonary or cardiac disorders Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with caution.
Lysfølsomhed Alle patienter, der modtager PhotoBarr, vil blive lysfølsomme og skal tage forholdsregler til at undgå at udsætte hud og øjne for direkte sollys eller stærkt indendørs lys (fra undersøgelseslamper inklusive tandlægelamper, operationslamper, uafskærmede lyspærer tæt ved, neonlys osv.) i mindst 90 dage efter behandling, da visse patienter kan forblive lysfølsomme i indtil 90 dage eller mere.
Photosensitivity All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at least 90 days after treatment as some patients may remain photosensitive for up to 90 days or more.
Nedsat leverfunktion Der er ingen tilgængelige farmakokinetiske data og sikkerhedsdata for patienter med leverfunktionsnedsættelse.
Hepatic Impairment No pharmacokinetic and safety data in patients with hepatic impairment are available.
Profylaktisk brug af kortikosteroider for at reducere strikturdannelse bør undgås under PDT, da denne anvendelse har vist sig ikke at reducere, og kan forværre, strikturdannelse.
19 Prophylactic use of corticosteroids to reduce stricture formation should be avoided during PDT as its use has shown not to reduce, and may worsen, stricture formation.
18 Hvis PDT skal anvendes før eller efter radioterapi, skal der være tilstrækkelig tid mellem terapierne til at sikre, at inflammationsreaktionen, der er fremkaldt af den første behandling, er svundet, inden den nye behandling påbegyndes.
If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
Forbindelser, der undertrykker aktive oxygenspecies eller bortskaffer radikaler såsom dimethylsulfoxid, β- caroten, ætanol, formiat og mannitol ville forventes at mindske PDT- aktivitet.
Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulphoxide, b- carotene, ethanol, formate and mannitol would be expected to decrease PDT activity.
Lægemidler, der reducerer koagulation, vasokonstriktion eller blodpladeaggregation, f. eks thromboxan A2 inhibitorer, kan mindske effektiviteten af PDT.
Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e. g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
5. 3).
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal 20 development (see section 5.3).
19 Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Til PDT - proceduren kan sedation være nødvendig, hvorfor der skal udvises forsigtighed.
For the PDT procedure, sedation may be required and consequently caution should be taken.
Disse manifestationer kan muligvis skyldes en pseudoporfyri- tilstand (forbigående medicininduceret kutan porfyri).
These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria).
Hyppigheder er defineret som: meget almindelig (> 1/ 10); almindelig (> 1/ 100 < 1/ 10); ikke almindelig (> 1/ 1. 000 < 1/ 100).
Frequencies are defined as: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100).
Oversigt over bivirkninger med natriumporfimer hos patienter med HGD og BO
Summary of adverse reactions with porfimer sodium in patients with HGD and BO
Infektioner og parasitære sygdomme Ikke almindelig:
Neoplasms benign,
Leukocytose Metabolisme og ernæring Meget almindelig:
Blood and the lymphatic system disorders Uncommon:
Dehydrering Almindelig:
21 Metabolism and nutrition disorders Very common:
Øjenirritation, øjenødem Øre - og labyrint Ikke almindelig:
Ear and labyrinth disorders Uncommon:
Hypertension, hæmorrhagi, hedestigninger, hypotension, orthostatisk hypotension Luftveje, thorax og mediastinum Almindelig:
Vascular disorders Uncommon:
Pleuraekssudat, faryngitis, atelektase, dyspnø
Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension
Kvælningsfornemmelse, funktionsdyspnø, hæmoptyse, hypoxi, tæt næse, aspirationspneumoni, produktiv hoste, respirationsdepression, respirationsvejskongestion, hvæsen Mave- tarm- kanalen Meget almindelig:
Pleural effusion, pharyngitis, atelectasis, dyspnoea Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory tract congestion, wheezing
Pyreksi Almindelig:
Gynaecomastia
Kulderystelser, træthed
22
Varmefølelse, erythem på injektionsstedet, somnolens, utilpashed, perifert ødem, smerter, fingertryksødem, temperaturintolerans, svaghed Undersøgelser Almindelig:
Congenital and familial and genetic disorders Uncommon:
Nedsat vægt, forhøjet legemstemperatur
Pigmented naevus
Nedsat blodalbumin, forhøjet blodklorid, forhøjet blodurea, nedsat hæmatokrit, nedsat hæmoglobin, nedsat oxygenmætning, nedsat totalprotein Traumer, forgiftninger og behandlingskomplikationer Almindelig:
Rigors, fatigue Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Smerter efter proceduren, afskrabning
Uncommon:
21
Weight decreased, body temperature increased Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, protein total decreased
En 51- årig adipøs mand blev behandlet med PhotoBarr PDT for HGD i BO, off- label.
A 51 year-old obese man was treated with PhotoBarr PDT for HGD in BO, off label.
Den anbefalede dosis på to 2 mg/ kg i stedet for den anbefalede enkeltdosis blev givet to gange med to dages mellemrum (10 patienter) og tre gange inden for to uger (1 patient), uden at der blev rapporteret nogen betydende bivirkninger.
The recommended 2 mg/ kg dose, instead of the recommended single administration, was given twice two days apart (10 patients) and three times within two weeks (1 patient) without any notable adverse reactions being reported.
Virkningsmekanisme Natriumporfimer er en blanding af porfyrinenheder, der er bundet sammen i kæder af to til otte enheder.
Mechanism of action Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
De cytotoksiske virkninger af natriumporfimer er lys - og oxygenafhængige.
The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
Clearance fra forskellige væv foregår i løbet af 40- 72 timer, men tumorer, hud og organer i det retikuloendoteliale system (inklusive lever og milt) tilbageholder natriumporfimer i længere tid.
Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Cellebeskadigelsen forårsaget
Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
22 af natriumporfimer PDT er en følge af formeringen af frie radikal- reaktioner.
Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Klinisk virkning I et kontrolleret klinisk forsøg blev en PhotoBarr PDT + OM (omeprazol) patientgruppe (n=183) sammenlignet med en gruppe patienter, der kun fik OM (n=70).
Clinical efficacy In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183) was compared to a group of patients receiving OM only (n=70).
Patienter, der indgik i denne undersøgelse, skulle have biopsi- verificeret HGD i Barretts øsofagus (BO).
Eligible patients for this study were to have biopsy-proven HGD in Barrett’ s oesophagus (BO).
Patienter randomiseret til behandling med PDT fik PhotoBarr i en dosis på 2 mg/ kg legemsvægt ved langsom intravenøs injektion over 3 til 5 minutter.
Patients randomised to treatment with PDT received PhotoBarr at a dose of 2 mg/ kg body weight through slow intravenous injection over 3 to 5 minutes.
Ved slutningen af den minimale opfølgning på to år var 13% i PhotoBarr PDT + OM- gruppen progredieret til cancer sammenlignet med 28% i OM alene gruppen i behandlingsintensions( ITT) - populationen.
24 By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population.
Sammenligning mellem overlevelseskurverne for de to behandlingsformer ved hjælp af log rank test viste en statistisk signifikant forskel mellem kurverne for de to grupper i ITT- populationen (p=0, 0014), hvilket viser en signifikant forsinkelse i progressionen til cancer.
Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014) indicating a significant delay in the progression to cancer.
Natriumporfimers farmakokinetik er blevet undersøgt hos 12 patienter med endobronchial cancer og hos 23 raske forsøgspersoner (11 mænd og 12 kvinder), som fik indgivet 2 mg/ kg natriumporfimer ved langsom intravenøs injektion.
The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/ kg porfimer sodium through slow intravenous injection.
23 Hos patienterne var den gennemsnitlige højeste plasmakoncentration (Cmax) 79, 6 μg/ ml (C. V.
In patients, the mean peak plasma concentration (Cmax) was 79.6 μ g/ ml (C. V.