Clinic Ace

Primær information

  • Handelsnavn:
  • Clinic Ace Vandopløseligt koncentrat
  • Lægemiddelform:
  • Vandopløseligt koncentrat
  • Sammensætning:
  • 360 g/l glyphosat
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

Lokation

  • Fås i:
  • Clinic Ace Vandopløseligt koncentrat
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb og søer m.v.)
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

® = Registered trademark of Nufarm

20 L

Nufarm Deutschland GmbH

Im MediaPark 4e

50670 Köln

Germany

Tel: (+49) 221/179179-0

22173/0315/DK/VS

CLINIC ACE

Ukrudtsmiddel

Må kun anvendes til visse former for ukrudtsbekæmpelse samt nedvisning.

Gældende fra 26. november 2015: Dette plantebeskyttelsesmiddel må kun købes

af professionelle og anvendes erhvervsmæssigt og kræver gyldig autorisation.

ADVARSEL

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed og miljøet i

fare (EUH401).

Forårsager alvorlig øjenirritation (H319).

Giftig for vandlevende organismer, med langvarige virkninger (H411).

Bær øjenbeskyttelse/ansigtsbeskyttelse (P280).

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for

plantebeskyttelsesmidler. Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til:

Ukrudtsbekæmpelse samt nedvisning i korn, korsblomstrede afgrøder, ærter,

hestebønner og græs. Må ikke behandles senere end 10 dage før høst.

Ukrudtsbekæmpelse under frugttræer indtil 1 måned før høst og om efteråret

efter høst.

Ukrudtsbekæmpelse efter såning og før fremspiring samt selektiv ukrudtsbekæm-

pelse i jordbrug ved hjælp af specielt udstyr.

Ukrudtsbekæmpelse i ikke spiselige havebrugs-, planteskole- og skovkulturer.

Ukrudtsbekæmpelse på parkeringsarealer, veje, indkørsler, fortove, havegange,

terrasser og udyrkede arealer.

Må ikke anvendes til ukrudtsbekæmpelse på offentlige arealer i perioder, hvor

der findes spiselige bær og frugter på arealet.

Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb og søer m.v.)

(Spe3).

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har

indeholdt produktet. Rens ikke sprøjteudstyr nær overfladevand (Sp1).

Opbevares utilgængeligt for børn (P102).

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

Brugsanvisningens doseringsangivelser må ikke overskrides.

Førstehjælp:

Hvis der er brug for lægehjælp, medbring da beholderen eller etiketten (P101).

VED KONTAKT MED ØJNENE: Skyl forsigtigt med vand i flere minutter. Fjern

eventuelle kontaktlinser, hvis dette kan gøres let. Fortsæt skylning.

(P305+P351+P338).

Ved vedvarende øjenirritation: Søg lægehjælp (P337+P313).

Registreringshaver:

DEKLARATION

Ukrudtsmiddel nr. 347-8

Analyse ved 20 °C: Indeholder 360 g glyphosat pr. liter (30 % w/w).

Isopropylaminsalt.

Midlet er et vandopløseligt koncentrat.

Mindst holdbar i to år efter produktionsdatoen.

Produktionsdato og batchnummer se emballagen.

Opbevares frostfritt

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og

plantebeskyttelsesmiddelforordningen 1107/2009.

ClinicAce 20L DK•22173:- 06.05.2015 9:49 Uhr Seite 1

BRUGSANVISNING

Clinic Ace anvendes mod kvik og andre flerårige græsser, tokimbladet ukrudt samt til nedvisning i korn, græs,

korsblomstrede afgrøder, ærter, hestebønner, på stubmarker, i frugtplantager, i havebrugs-, planteskole- og

skovkulturer, samt på udyrkede arealer. Clinic Ace virker ved, at midlet optages gennem bladene og fordeler

sig med plantens saftstrøm rundt i hele planten. Efter 10 dage vil denne transport normalt være tilendebragt,

og jorden kan bearbejdes og tilplantes. Udsprøjtning af Clinic Ace skal foretages på tørre planter. Den bedste

effekt opnås, når planterne er i god vækst. Temperatur over 15 grader, tilpas jordfugtighed og høj luftfugtig-

hed vil sædvanligvis give det bedste resultat. Hvis Clinic Ace anvendes under andre forhold, må langsommere

effekt forventes. Regn inden 6 timer efter behandling vil normalt forringe virkningen. Clinic Ace bindes umid-

delbart til jordens ler- og humusmateriale og inaktiveres derfor ved kontakt med denne. Nedbrydning af Clinic

Ace sker hovedsageligt mikrobiologisk til naturligt forekommende stoffer som vand, kuldioxid, ammonium og

phosphat. Bemærk at der kan være risiko for, at der i en bestand af samme træarter kan forekomme rodsam-

menfletninger, og dermed mulighed for overførsel af Clinic Ace fra et behandlet træ til nabotræet. Pas endvi-

dere på ved behandling af evt. rodskud. Afgrøder beregnet til udsæd må ikke behandles.

SPRØJTETEKNIK

Det er vigtigt, at sprøjtevæsken fordeles jævnt over hele arealet. Undgå vinddrift til naboafgrøder og læhegn,

der vil skades betydeligt, hvis de rammes af Clinic Ace.

Vandmængde:

Clinic Ace udsprøjtes i op til 200 l/ha. Ved doseringer under 3 l/ha anbefales højst 150

l/ha. Der bør anvendes fladsprededyser og tryk mellem 2.5 og 3 bar.

ANVENDELSESOMRÅDER:

KORN FØR HØST:

Til bekæmpelse af kvik, andre græsser samt tokimbladet ukrudt. Korn til udsæd må ikke behandles. Korn skal

behandles senest 10 dage før høst. Sprøjtning udføres, når kernerne er hårde og vanskelige at dele med en fin-

gernegl. Kvikken bør på sprøjtetidspunktet være i aktiv vækst.

Dosering:

Kvikmængde lavere end 25 skud pr. m

2.0 l/ha

Kvikmængde højere end 25 skud pr. m

3.0 l/ha

RAPS, ÆRTER OG HESTEBØNNER - FØR HØST:

Til bekæmpelse af kvik og tokimbladet ukrudt samt nedvisning.

RAPS:

Sprøjtningen udføres, når vandindholdet i frøene er under 30 %. Dette stadie indtræffer normalt, når største-

parten af skulperne i rapsen er gulgrønne med gulbrune og enkelte sorte frø. Sprøjtetidspunktet vil indtræde 2

- 4 dage før normal skårlægning. Behandlede afgrøder høstes direkte mellem 14 og 21 dage efter sprøjtning.

Dosering:

3.0 l/ha

ÆRTER:

Ærter behandles, når 70 - 75 % af marken har skiftet farve fra gulgrøn til gulbrun. ærterne fra de øverste bælge

bør være faste og kunne flækkes med 2 fingre. På dette tidspunkt er ærternes nederste bælge mellembrune til

brune, de midterste bælge lysegule, den øverste bælg er lysegrøn til lysegul. Specielt ved lav dosering er det

meget vigtigt at sprøjtebetingelser og –teknik er de bedst mulige. Nedvisningsperioden kan - afhængig af

temperaturen - strække sig udover 10 dage.

Dosering:

Kvikmængde lavere end 25 skud pr. m

2.0 l/ha

Kvikmængde højere end 25 skud pr. m

3.0 l/ha

Nedvisning af ærter

4.0 l/ha

HESTEBØNNER:

Behandlingen i hestebønner udføres 10 - 14 dage før planlagt høst. Det rette sprøjtetidspunkt finder man let-

test ved at følge bælgenes udvikling. Sprøjt når ca. 3/4 af bælgene har skiftet farve til helt sort.

Nedvisningsperioden kan dog strække sig udover det ovennævnte antal dage.

Dosering:

Bekæmpelse af kvik og andet ukrudt

3.0 l/ha

Nedvisning af hestebønner

4.0 l/ha

STUBMARKER:

Anvendes til bekæmpelse af kvik og tokimbladet ukrudt samt genspiret korn. Halmen bør fjernes straks efter

høst, således at kvikken kan komme i god vækst. Når kvikken har 3-6 aktive blade, kan der behandles med Cli-

nic Ace. I tilfælde af at halmen snittes efter høst, må den snittes fint og fordeles godt for at få optimal effekt

over hele marken. Behandling med Clinic Ace bør altid foretages på ubearbejdet jord efter høst, når ukrudtet

er i god vækst, og har en passende udvikling. Undgå ved høst at sætte for høj stub, som kan forringe den ak-

tive genvækst af kvikken. En stubbehandling kan foretages til langt hen på året, så længe klimaforholdene tilla-

der det. Enkelte frostnætter med temperatur ned til –3 °C før sprøjtning vil ikke have indflydelse på virkningen.

Jordbearbejdning kan påbegyndes 10 dage efter behandlingen.

Dosering:

Genspiret korn og småt etårigt ukrudt

1.5 - 2.0 l/ha

Kvik

3.0 - 4.0 l/ha

Doseringen på 3 l/ha kan anvendes, når følgende betingelser er tilstede:

* Høj luftfugtighed

* Temperatur over 15 °C

* Højt vejr (solskin) fra sprøjtetidspunkt (formiddag) til aften.

STUBMARKER EFTER FRØGRÆS:

Halmen bør fjernes straks efter høst, således at kvikken og græsserne kan komme i god vækst. Når kvikken har

3 - 6 aktive blade, kan der behandles med Clinic Ace. Behandlingen med Clinic Ace bør altid foretaget på ube-

arbejdet jord efter høst, når ukrudtet er i god vækst og har en passende udvikling. Undgå ved høst at sætte

for høj stub, som kan forringe den aktive genvækst af kvikken og græsserne. Jordbearbejdning kan påbegyn-

des 10 dage efter behandlingen.

Dosering:

4.0 - 6.0 l/ha

Generelt anvendes 4 liter/ha mod kvik og genvækst af frøgræsser. 5 - 6 liter/ha anvendes til bekæmpelse af

rødsvingel, engrapgræs eller andre smalbladede frøgræsarter.

OMLÆGNING AF GRÆS:

For effektiv kvikbekæmpelse skal planterne være i aktiv vækst og med 3 - 6 blade. Før en eventual direkte

såning bør græsset samt andet plantemateriale altid fjernes fra marken. Dette kan ske allerede 10 dage efter

behandling.

Dosering:

Kvik og andre bredbladede græsser

4.0 l/ha

Smalbladede græsarter

5.0 - 6.0 l/ha

GRÆS FØR SIDSTE SLÆT:

Clinic Ace anvendes til bekæmpelse af kvik og kulturgræsser inden høst af sidste slæt. Afgrøden kan anvendes

til hø, afgræsning, staldfodring, ensilering eller pillefabrikation. Græsset og kvikken (kvik 3-6 aktive blade) bør

være veludviklet, i god vækst og 15 - 20 cm på sprøjtetidspunktet. Vær sikker på, at kvikken ikke er dækket af

afgrøden. Snarest muligt efter behandlingsfristens udløb (10 dage) høstes græsset.

Dosering: 4.0 l/ha

FORÅRSANVENDELSE:

Clinic Ace anvendes mod kvik samt andet fremspiret ukrudt. 3 liter anvendes på lettere kvikbefængte marker.

4 liter på kraftigere kvikforekomster. Effekten afhænger dog meget af udviklingsstadiet på kvikken. Kvikken

skal have 3 - 4 blade på sprøjtetidspunktet. Om foråret vil kvikken normalt ikke være så veludviklet, hvorfor der

må påregnes lavere effekt. Ikke udvintrede kornplanter i en ellers udvintret vintersædsmark kan bekæmpes, så

snart vækstpunktet grønnes.

Dosering:

Kvikbekæmpelse

3.0 - 4.0 l/ha

Bekæmpelse af korn i udvintret vintersæd

1.0 - 1.5 l/ha

DIREKTE SÅNING:

Anvendes direkte såning efter en behandling med Clinic Ace fjernes halm og andet plantemateriale. Ved sprøj-

tning umiddelbart efter en direkte såning kræves det, at udsæden er godt dækket.

Dosering:

Ny fremspiret tokimbladet ukrudt,

enårig rapgræs og spildkorn

1.5 l/ha

Kvikbekæmpelse

3.0 - 4.0 l/ha

Bemærk: Under nedbrydning af større mængder plantemateriale, f.eks. kvikrødder, kan der I nogle tilfælde

dannes spirehæmmende stoffer. En grundig jordbearbejdning kan forhindre eller mindske problemet.

SELEKTIV BEKÆMPELSE MED SÆRLIGT UDSTYR:

Ukrudt (f.eks. ukrudtsroer og tidsler) kan bekæmpes med påstrygningsudstyr, når ukrudtet er 10-15 cm højere

end afgrøden. Afgrøden må ikke rammes.

Dosering: 50 % opløsning (1 del Clinic Ace + 1 del vand)

FRUGTPLANTAGER OG SKOVBRUG:

Bedste behandlingstidspunkt er lige før begyndende blomstring, når ukrudtet er i god vækst. Clinic Ace må

ikke komme i berøring med træernes løv eller rodskud, idet træerne da kan skades betydeligt. Især efter mid-

ten af juni vil der være større risiko for skade på træerne p.g.a. fremkomne rodskud.

Anvend afskærmet sprøjtning. Pas på vinddrift.

Dosering: 3.0 - 6.0 l/ha

Kvik og andre græsser bekæmpes med 3 liter/ha. Mod tokimbladet flerårigt rodukrudt anvendes højeste dose-

ring.

Grankulturer:

I Rødgran, Normannsgran og Kæmpegran kan Clinic Ace anvendes om efteråret, når

strækningsvæksten er afsluttet og årsskuddene er modne og endeknopperne er dannede. Tidligst når gra-

nerne er rodfaste på blivende sted.

Dosering: 3.0 - 3.5 l/ha i 400 - 500 l vand/ha

Stødbehandling af fældede træer i skove og på industriarealer mod genvækst og rodskud.

Nytældede træer behandles straks efter fældning med Clinic Ace som sikring mod genvækst og rodskud. Cli-

nic Ace kan f.eks. påføres med pensel eller rygsprøjte. Behandlingen foretages på selve snitfladen, men dog

især på de vedagtige dele nærmest barken. Behandlingen foretages, når træernes saftstrøm er nedadgående,

dvs. fra ca. oktober til slutningen af februar.

Behandling i træernes saftstigningsperiode har ringere effekt.

Vejledende dosering:

Blanding ved temperatur over +5 °C 200 ml Clinic Ace plus 800 ml vand.

Blanding ved temperatur under +5 °C 200 ml Clinic Ace plus 200 ml antifrostvæske (kølervæske) plus 600 ml

vand.

Antifrostvæske tilsættes for at lette udbringningen af blandingen i perioder med lave temperaturer.

Udyrkede og utilplantede arealer:

Clinic Ace kan anvendes på utilplantede arealer gennem hele vækstsæsonen med 4 - 6 liter/ha.

Ukrudtet bør være veludviklet og i aktiv vækst på behandlingstidspunktet.

På tæt og kraftig ukrudtsbestand anvendes 6 liter/ha. 10 dage efter behandling kan jorden bearbejdes og til-

plantes.

Vandmængde:

200 - 300 liter/ha

Rygsprøjte:

Anvendelse af rygsprøjte vil være formålstjenlig, når mindre arealer skal 0.2 -0.3 l Clinic

Ace i 10 - 15 liter vand vil kunne dække et areal på ca. 500 m

NB! Sprøjt kun på det der skal bekæmpes. Pas på vinddrift. Anvend evt. Afskærmet sprøjtning.

TILBEREDNING AF SPRØJTEVÆSKE:

Fyld beholderen 3/4 med vand, tilsæt Clinic og fyld derefter op med vand. Start omrøring.

RENGØRING AF SPRØJTEUDSTYR:

Efter endt sprøjtearbejde skal sprøjten og traktor rengøres enten i marken eller på vaskepladsen. En uvasket

sprøjte skal placeres i den behandlede mark på vaskepladsen eller under tag. Sprøjten skal være monteret

med spuledyser til indvendig rengøring af tanken, og sprøjten skal være monteret med separat vandtank med

tilstrækkelig kapacitet således, at restsprøjtevæske kan fortyndes, og der kan foretages en grundig rengøring i

marken. Restsprøjtevæske skal på passende vis fortyndes 50 gange med vand og udsprøjtes i den behandlede

mark (uden at den maksimalt tilladte dosering for det pågældende middel herved overskrides). Rengøring i

øvrigt foretages med egnede rengøringsmidler (se evt. etiketten for det

sidst anvendte middel for specifikke anvisninger). Samtidig med at filtre, slanger og dyser kontrolleres for

urenheder og eventuelle belægninger. Vaskevandet opsamles i egnede beholdere og udbringes iht. gældende

regler.

Bortskaffelse af tom emballage:

Indholdet/beholderen bortskaffes i overensstemmelse med kommunale regler for affaldshåndtering (P501).

Rester skal afleveres til den kommunale affaldsordning for farligt affald.

Tomme beholdere kan bortskaffes med dagrenovationen. Den tomme beholder bør skylles inden bortskaf-

felse. Skyllevandet hældes op i sprøjtevæsken.

Emballagen må ikke genbruges.

22173/0315/DK/RS

CLINIC ACE

ClinicAce 20L DK•22173:- 06.05.2015 9:49 Uhr Seite 2

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AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

11-7-2018

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

Danish Medicines Agency

3-7-2018

DKMA Update June 2018

DKMA Update June 2018

In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

28-6-2018

Clinical Investigator Inspection List (CLIIL)

Clinical Investigator Inspection List (CLIIL)

The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.

FDA - U.S. Food and Drug Administration

18-5-2018

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

FDA - U.S. Food and Drug Administration

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

9-5-2018

FDA seeks permanent injunctions against two stem cell clinics

FDA seeks permanent injunctions against two stem cell clinics

FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval

FDA - U.S. Food and Drug Administration

3-5-2018

Better conditions for clinical trials in Denmark

Better conditions for clinical trials in Denmark

The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines.

Danish Medicines Agency

22-3-2018

New concept for national scientific advice

New concept for national scientific advice

The Danish Medicines Agency will soon launch a new national scientific advice concept for companies, hospital researchers and others who require advice on requirements for marketing authorisations or clinical trials.

Danish Medicines Agency

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

3-7-2017

New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.

Danish Medicines Agency

13-6-2017

Annual report 2016 - Clinical trials of medicines

Annual report 2016 - Clinical trials of medicines

LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

Danish Medicines Agency

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

5-9-2018

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulatory and coverage decisions

FDA - U.S. Food and Drug Administration

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

22-7-2018

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/t

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/t

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy. pic.twitter.com/tzZKxpQbmx

FDA - U.S. Food and Drug Administration

19-7-2018

Regulatory and procedural guideline:  Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Critical Path Global Ltd.’s Critical Path for Parkinson’s (CPP) is a multinational consortium of the Critical Path Institute supported by Parkinson’s UK and industry. This broad collaboration of pharmaceutical companies, government agencies, academic institutions, and charities aims to accelerate the development of therapies for Parkinson’s disease (PD).

Europe - EMA - European Medicines Agency

1-7-2018

Annual Charge Exemption (ACE) scheme forms

Annual Charge Exemption (ACE) scheme forms

A declaration of low value ($0) turnover can be made between 1 and 22 July

Therapeutic Goods Administration - Australia

13-6-2018

Scientific guideline:  Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum ...

Europe - EMA - European Medicines Agency

12-6-2018

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)3805 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/16/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

16-5-2018

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials.  http://ow.ly/1wzB30jXeX2  #FDAGreatDebatepic.twitter.com/rcnrVp9K8u

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials. http://ow.ly/1wzB30jXeX2  #FDAGreatDebatepic.twitter.com/rcnrVp9K8u

Watch LIVE today at 1pm ET: The Great Debate: What is Enough… Women in Clinical Trials. http://ow.ly/1wzB30jXeX2  #FDAGreatDebate pic.twitter.com/rcnrVp9K8u

FDA - U.S. Food and Drug Administration

14-5-2018

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”.  http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrialspic.twitter.com/mvltDqmK8v

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”. http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrialspic.twitter.com/mvltDqmK8v

Celebrate National Women’s Health Week by joining us this Wednesday at 1 p.m. ET for “The Great Debate: What is Enough… Women in Clinical Trials”. http://ow.ly/GF8m30jTpFn  #NWHW #clinicaltrials pic.twitter.com/mvltDqmK8v

FDA - U.S. Food and Drug Administration

23-4-2018

Which clinical trial scheme should I choose?

Which clinical trial scheme should I choose?

New interactive tool for sponsors

Therapeutic Goods Administration - Australia