natgillin/translations-raw huggingface dataset:
QTcF-øgning fra baseline på mere end 60 msek.
QTcF increase from baseline exceeding 60 msec was observed in <1% of patients while on the study medicinal product.
- pædiatriske patienter med Philadelphiakromosom-positiv CML, i kronisk fase, som er resistent eller intolerant over for tidligere behandling, herunder imatinib.
Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med nilotinib i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen.
Adult Philadelphia chromosome positive CML patients in chronic phase who have achieved a sustained deep molecular response (MR 4.5) on nilotinib following prior imatinib therapy Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Ændringen i baseline i tid for det gennemsnitlige QTcF-interval ved steady-state var 6 msek.
The change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had an absolute QTcF >500 msec while on the study medicinal product.
PVC/PVDC/Alu [i folder] 112 hårde kapsler
PVC/PVDC/Alu [in wallet] 112 hard capsules
Titandioxid (E 171) Jernoxid, rød (E 172) Jernoxid, gul (E 172)
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
I alt 305 (36,1 %) af alle patienter var ikke evaluerbare for MMR ved 48 måneder (98 i nilotinib-gruppen, der fik 300 mg 2 gange dagligt, 88 i nilotinib-gruppen, der fik 400 mg 2 gange dagligt, og 119 i imatinib-gruppen) på grund af manglende/ikke evaluerbare PCR-vurderinger (n=18), atypiske transkriptioner ved baseline (n=8) eller ophør før 48-måneder (n=279).
A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg twice daily group, 88 in the nilotinib 400 mg twice daily group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Muskuloskeletale smerter, lændesmerter
Musculoskeletal stiffness, joint swelling
KARTON MED DELPAKNINGER
INTERMEDIATE CARTON
laboratorieabnormaliteter), som rapporteres hos mindst 5 % af de voksne patienter i kliniske studier af Tasigna, som ligger til grund for de godkendte indikationer, er vist i tabel 3.
Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients in Tasigna clinical studies that serve as the basis for the approved indications are shown in Table 3.
nældefeber, svampeinfektion på fødderne - fortykkede hudpletter med rød/sølvfarvet hud (tegn på psoriasis) - øget hudoverfølsomhed - blødning, ømme eller hævede gummer - næseblod - tør mund, ondt i halsen, sår i munden - hyppig vandladning - hæmorroider, bylder i endetarmen - betændelse i tarmene (enterocolitis) - herpes virus infektion - følelse af spændte bryster, kraftige menstruationer, hævelse af brystvorterne - spiseforstyrrelse, vægttab - forstørrelse af bryster hos mænd - symptomer på restless legs syndrom (en uimodståelig trang til at bevæge en del af kroppen, som regel benene, ledsaget af ubehagelige følelser)
- increased skin sensitivity - bleeding, tender or enlarged gums - nose bleed - dry mouth, sore throat, mouth sores - frequent urine output - haemorrhoids, anal abscess - enterocolitis (inflammation of the bowel) - herpes virus infection - feeling of hardening in the breasts, heavy periods, nipple swelling - appetite disorder, weight decreased - breast enlargement in men - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Tasigna er indiceret til behandling af: - voksne og pædiatriske patienter med nydiagnosticeret Philadelphiakromosom-positiv kronisk myeloid leukæmi (CML) i kronisk fase.
Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.
Eksfoliativt udslæt, medikamentelt udsæt, smerte i huden, ekkymose, hævet ansigt
Exfoliative rash, drug eruption, skin pain, ecchymosis, swelling face
Febril neutropeni
Renal impairment
PVC/PVDC/Alu [i karton] 28 hårde kapsler
PVC/PVDC/Alu [in carton] 28 hard capsules
Øjenblødning, periorbitalt ødem, øjenkløe, konjunktivitis, tørre øjne (inklusive xeroftalmi)
Eye haemorrhage, periorbital oedema, eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Kronisk CML n=321
Chronic phase n=321
Ingen forsøgspersoner havde et QTcF >450 msek.
No subject had a QTcF >450 msec. Additionally, no clinically relevant arrhythmias were observed during the conduct of the trial.
Brystspændinger, menorrhagi, hævede brystvorter Almene symptomer og reaktioner på administrationsstedet Almindelig:
Breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Multipakning: 112 (4 foldere med 28) hårde kapsler.
Multipack: 112 (4 wallets of 28) hard capsules.
Pulmonal hypertension, pibende vejrtrækning, orofaryngeal smerte
Pulmonary hypertension, wheezing, oropharyngeal pain Gastrointestinal disorders
Hvis den tidligere dosis var 400 mg 1 gang dagligt hos voksne patienter, eller 230 mg/m
If the prior dose was 400 mg once daily in adult patients or 230 mg/m once daily in paediatric patients, treatment should be discontinued.
Tasigna bør anvendes med forsigtighed til patienter, som har QT-forlængelse eller har signifikant risiko for at udvikle det.
Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc, such as those: - with congenital long QT prolongation - with uncontrolled or significant cardiac disease including recent myocardial infarction,
Periorbitalt ødem, blefaritis, smerter i øjnene, korioretinopati, allergisk konjunktivitis, okulær overfladesygdom, sløret syn
Periorbital oedema, blepharitis, eye pain, chorioretinopathy, conjunctivitis allergic, ocular surface disease, vision blurred Ear and labyrinth disorders Common:
Tal med din læge, hvis du har spørgsmål til, hvor længe du skal tage Tasigna.
If you have questions about how long to take Tasigna, talk to your doctor.
PVC/PVDC/Alu [i folder] 28 hårde kapsler
PVC/PVDC/Alu [in wallet] 28 hard capsules
Hvis du har taget for meget Tasigna
If you take more Tasigna than you should
Baseret på Kaplan-Meier-estimater af varigheden af første MMR var andelen af patienter, der opretholdt responset i 72 måneder, blandt patienter, der opnåede MMR, 92,5 % (95 % CI: 88,6-96,4 %) i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 92,2 % (95 % CI: 88,5-95,9 %) i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 88,0 % (95 % CI: 83,0-93,1 %) i gruppen, der fik imatinib 400 mg 1 gang dagligt.
88.6-96.4%) in the nilotinib 300 mg twice daily group, 92.2% (95% CI: 88.5-95.9%) in the nilotinib 400 mg twice daily group and 88.0% (95% CI: 83.0-93.1%) in the imatinib 400 mg once daily group.
Hver hård kapsel indeholder 200 mg nilotinib (som hydrochloridmonohydrat).
Each hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
En hård kapsel indeholder 200 mg nilotinib (som hydrochloridmonohydrat).
One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Shellac (E 904) Vandfri alkohol Isopropylalkohol Butylalkohol
Shellac (E904) Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene glycol Strong ammonia solution Potassium hydroxide Red iron oxide (E172)
Knoglesmerter, rygsmerter, muskelsvaghed
Bone pain, back pain, muscular weakness
Unormal leverfunktion.
Hepatic function abnormal
svampeinfektion på fødderne - fortykkede hudpletter med rød/sølvfarvet hud (tegn på psoriasis) - blødning, ømme eller hævede gummer - vorter i munden - rødme og/eller hævelse af håndflader og fodsåler med risiko for afskalning af huden (også kaldet hand-foot-syndrom) - øget lysfølsomhed i huden over for lys -- hørebesvær, smerter i ørerne, støj (ringen) for ørene - betændelse i ledene - ufrivillig vandladning - betændelse i tarmene (enterocolitis) - hæmorroider, bylder i endetarmen - følelse af spændte bryster, kraftige menstruationer, hævelse af brystvorterne - symptomer på restless legs syndrom (en uimodståelig trang til at bevæge en del af kroppen, som regel benene, ledsaget af ubehagelige følelser)
The following other side effects have been reported with frequency not known (cannot be estimated from the available data): - allergy (hypersensitivity to Tasigna) - memory loss, disturbed mood - skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, fungal infection of the feet - thickened patches of red/silver skin (signs of psoriasis) - bleeding, tender or enlarged gums - oral warts - reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot syndrome) - increased sensitivity of the skin to light - difficulty hearing, ear pain, noises (ringing) in the ears - joint inflammation - urinary incontinence - enterocolitis (inflammation of the bowel) - haemorrhoids, anal abscess - feeling of hardening in the breasts, heavy periods, nipple swelling - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Hver hård kapsel indeholder 50 mg nilotinib (som hydrochloridmonohydrat).
Each hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
En hård kapsel indeholder 150 mg nilotinib (som hydrochloridmonohydrat).
One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Hver hård kapsel indeholder 150 mg nilotinib (som hydrochloridmonohydrat).
Each hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Desorientering, konfusion, amnesi, dysfori
Disorientation, confusional state, amnesia, dysphoria Nervous system disorders Common:
En hård kapsel indeholder 50 mg nilotinib (som hydrochloridmonohydrat).
One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Ikke almindelig:
Very common:
Amnesi, dysfori
Muscle spasms
Væskeretention og ødem
Fluid retention and oedema
Funktionsdyspnø, pleuritis, epistaxis, orofaryngeal smerte
Dyspnoea exertional, pleurisy, epistaxis, oropharyngeal pain Gastrointestinal disorders
Metabolisme og ernæring
Metabolism and nutrition disorders Very common:
Muskelspasme r
Printing ink
Den sædvanlige dosis er 600 mg dagligt.
Use in adults - The recommended dose is 600 mg per day.
12 0 Meget almindelig
2 Very common
Kapsel
Capsule shell
Mave-tarm-kanalen Kvalme
Gastrointestinal disorders Nausea
Gynækomasti, brystspændinger, menorrhagi, hævede brystvorter Almene symptomer og reaktioner på administrationsstedet Almindelig:
Gynaecomastia, breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Det betyder, at det er identisk med et "referencelægemiddel", der indeholder det samme aktive stof.
This means that it is similar to a ‘reference medicine' containing the same active substance.
Gennemgangen blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Gennemgangen af Flurbiprofen Geiser blev på foranledning af Spanien indledt den 27. juni 2019 i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF.
The review of Flurbiprofen Geiser was initiated on 27 June 2019 at the request of Spain, under Article 29(4) of Directive 2001/83/EC.
Da der er en lille forskel i koncentration mellem de to lægemidler, blev det vurderet, at data fra et klinisk studie hos raske forsøgspersoner ville være påkrævet for at afgøre, om de har samme virkning.
Because there is a small difference in concentration between the two medicines, it was considered that data from a clinical trial in healthy volunteers would be needed to determine whether they have the same effect.
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den spanske lægemiddelstyrelse indbragte den 10. juni 2019 sagen for EMA med henblik på voldgift.
However, the Member States were not able to reach an agreement and the Spanish medicines agency referred the matter to EMA for arbitration on 10 June 2019.
Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Spanien) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", her Tjekkiet, Holland, Portugal og Slovakiet), hvor virksomheden har søgt om markedsføringstilladelse.
This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, the Netherlands, Portugal and Slovakia) where the company has applied for a marketing authorisation.
Den 17. oktober 2019 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Flurbiprofen Geiser efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse.
On 17 October 2019, the European Medicines Agency completed a review of Flurbiprofen Geiser following a disagreement among EU Member States regarding its authorisation.
Flurbiprofen Geiser blev udviklet som et "hybridlægemiddel".
Flurbiprofen Geiser was developed as a ‘hybrid medicine'.
Agenturet konkluderede, at fordelene ved Flurbiprofen Geiser opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Spanien, kan anerkendes i andre EU-medlemsstater, hvor virksomheden har ansøgt om en markedsføringstilladelse: Tjekkiet, Holland, Portugal og Slovakiet.
The Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and the marketing authorisation can be granted in Spain and in other Member States of the EU where the company has applied for a marketing authorisation: Czech Republic, the Netherlands, Portugal and Slovakia.
Flurbiprofen Geiser indeholder det aktive stof flurbiprofen, der er et non-steroidt antiinflammatorisk lægemiddel (NSAID), som reducerer kroppens dannelse af såkaldte prostaglandiner.
Flurbiprofen Geiser contains the active substance flurbiprofen, a 'non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Hvorfor blev Flurbiprofen Geiser undersøgt?
Why was Flurbiprofen Geiser reviewed?
Europa-Kommissionen traf en juridisk bindende afgørelse for hele EU om markedsføringstilladelsen for Flurbiprofen Geiser den 16. december 2019.
The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Flurbiprofen Geiser on 16/12/2019.
Dette understøttes af data, der viser, at selv meget forskellige former af flurbiprofen-holdige lægemidler, der tages gennem munden (som f.eks. sugetabletter, granulat og spray), opfører sig ens i kroppen.
This is supported by data showing that even flurbiprofen medicines taken by mouth in very different forms, such as lozenges, granules and spray, behave the same way in the body.
Begrundelsen for indbringelsen var betænkeligheder ved, at de indsendte laboratoriedata ikke var tilstrækkelige til at påvise, at Flurbiprofen Geiser er lige så effektivt som Strefen Direct.
The grounds for the referral were concerns that the laboratory data submitted were not enough to show that Flurbiprofen Geiser is equally as effective as Strefen Direct.
Referencelægemidlet (Strefen Direct) har imidlertid en anden koncentration end Flurbiprofen Geiser.
However, the reference medicine, Strefen Direct, has a different concentration to Flurbiprofen Geiser.
EMA anbefaler godkendelse af Flurbiprogen Geiser (flurbiprofen, 8,75 mg; mundhulespray) i EU
EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU
Hvad er Flurbiprofen Geiser?
What is Flurbiprofen Geiser?
Prostaglandiner medvirker til smerter og inflammation i kroppen, og ved at nedsætte dannelsen af prostaglandiner kan man derfor dæmpe smerter og inflammation.
Since some prostaglandins are involved in causing pain and inflammation in the body, reducing prostaglandin production reduces pain and inflammation.
Offentliggjorte data viser, at forskelle af denne størrelsesorden i koncentrationen af aktivt stof, smagen og mængden af cyclodextriner ikke påvirker virkningen af lægemidlet.
Published data show that differences of this size in concentration of the active substance, flavour and amount of cyclodextrins do not affect how the medicine works.
søgte om at få Flurbiprofen Geiser godkendt hos den spanske lægemiddelstyrelse gennem en decentraliseret procedure.
submitted Flurbiprofen Geiser to the Spanish medicines agency for a decentralised procedure.
Efter gennemgang af de tilgængelige data vurderede EMA, at forskellene mellem Flurbiprofen Geiser og Strefen Direct er små og ikke påvirker mængden af aktivt stof, der frigives i munden og til blodbanen.
Having reviewed the available data, EMA considered that differences between Flurbiprofen Geiser and Strefen Direct are minor and do not affect the amount of active substance that is released in the mouth and into the bloodstream.
EMA anbefaler godkendelse af Flurbiprogen Geiser (flurbiprofen, 8,75 mg; mundhulespray) i EU EMA/631051/2019
EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU EMA/631051/2019
På grundlag af gennemgangen af de aktuelt tilgængelige data vurderede agenturet, at fordelene ved Flurbiprofen Geiser opvejer risiciene, og anbefalede derfor udstedelse af markedsføringstilladelse for Flurbiprofen Geiser i alle de berørte medlemsstater.
Based on evaluation of the currently available data, the Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and therefore the marketing authorisation for Flurbiprofen Geiser should be granted in all concerned Member States.
Lægemidlerne har også forskellig smag og forskellige mængder af cyclodextriner, og det kan påvirke optagelsen af det aktive stof i kroppen.
The medicines also have different flavours and different amounts of cyclodextrins and this could affect how the active substance is taken up into the body.
Flurbiprofen Geiser er et lægemiddel, der anvendes til kortvarig lindring af ondt i halsen.
Flurbiprofen Geiser is a medicine used for the short-term relief of symptoms of sore throat.
Flurbiprofen Geiser har desuden en anden smag og indeholder mindre mængder af såkaldte cyclodextriner, der medvirker til at stabilisere opløsningen.
In addition Flurbiprofen Geiser has a different flavour and contains smaller amounts of substances called cyclodextrins, which help to stabilise the solution.
Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
Name Strength Pharmaceutical Form
Indhold Pakningsstørrelse
Package size Withdrawal Period
Indgivelsesvej Emballage
Packaging Content
Du vil muligvis have behov for at ligge ned, indtil du får det bedre.
You will probably need to lie down until you feel better.
Hovedparten af disse reaktioner blev rapporteret til at være af ”mild” til ”moderat” alvorlighed.
The majority of these reactions was reported to be of “mild” to “moderate” severity.
Andre symptomer kan omfatte:
Other symptoms may include:
Langvarig behandling (mindst 48 uger)
Long-term exposure (at least 48 weeks)
Injektionen skal foretages med et stadigt, kontinuerligt tryk.
The injection should be performed with steady, continuous pressure.
• En ikke almindelig, men alvorlig reaktion kan opstå efter hver injektion, du får.
• An uncommon but serious reaction might occur after you receive each injection.
Lægen eller sygeplejersken vil måske også måle dit blodtryk og puls.
The doctor or nurse may also want to measure your blood pressure and pulse.
Patienten bør følges nøje i denne periode.
Patients should be closely monitored during this period.
Ingen oral antipsykotisk supplering blev tilladt.
No oral antipsychotic supplementation was allowed.
I nogle tilfælde kan disse symptomer medføre tab af bevidsthed.
In some cases, these symptoms can lead to unconsciousness.
Mennesker med denne sygdom kan også føle sig deprimerede, angste eller anspændte.
People with this disease may also feel depressed, anxious or tense.
Der udvikledes tolerance overfor CNS-depressionen.
Tolerance developed to the CNS depression.
Under behandling kan dosis efterfølgende justeres på basis af den individuelle kliniske status.
During treatment dose may subsequently be adjusted on the basis of individual clinical status.
Absorptionen og eliminationen er komplet efter omkring seks til otte måneder efter den sidste injektion.
The absorption and elimination are complete approximately six to eight months after the last injection.
Brug til ældre (>75 år)
Use in elderly (>75 years)
Hvis det ikke anvendes straks, er opbevaringstid og -forhold forud for anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved 20 - 25 ºC.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
Disse reaktioner opstod ved < 0,1 % af injektionerne og hos omkring 2 % af patienterne.
These reactions occurred in <0.1% of injections and approximately 2% of patients.
Under antipsykotisk behandling kan bedring i patientens kliniske tilstand vare fra flere dage til nogle uger.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Oral olanzapin distribueres hurtigt.
Distribution Oral olanzapine is rapidly distributed.
Pulver Ingen.
Powder None
• Stigning i blodtryk
• increase in blood pressure
ZYPADHERA kan nogle gange komme for hurtigt ind i blodbanen.
ZYPADHERA can sometimes enter the bloodstream too quickly.
Udvælg og forbered et injektionssted i glutealregionen.
Select and prepare a site for injection in the gluteal area.
Bemærk, at der er mere solvens i hætteglasset, end der er brug for til rekonstitution.
It is important to note that there is more solvent in the vial than is needed to reconstitute.
Patienten bør monitoreres omhyggeligt for tegn på tilbagefald i de første en til to måneder af behandlingen.
Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Tæt medicinsk kontrol og overvågning bør fortsætte, indtil patienten kommer sig.
Close medical supervision and monitoring should continue until the patient recovers.
I de fleste tilfælde havde de initiale tegn og symptomer relateret til denne reaktion vist sig inden for 1 time efter injektionen, og i alle tilfælde blev fuldstændig bedring rapporteret inden for 24-72 timer efter injektionen.
In most cases, initial signs and symptoms related to this reaction have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 - 72 hours after injection.
Et undervisningsprogram til sundhedspersonalet (læger-sygeplejersker-farmaceuter) skal indeholde,
An education program to the health care professionals (HCP) (doctors-nurses-pharmacist) shall address,
Selv om det er usandsynligt, kan du få symptomerne efter mere end 3 timer efter indsprøjtningen.
Although unlikely, you may get the symptoms more than 3 hours after the injection.
Det opslæmmede lægemiddel vil være gult og uigennemsigtigt.
The suspended product will be yellow and opaque.