Thiopental Life

Primær information

  • Handelsnavn:
  • Thiopental Life pulver til injektionsvæske, opløsning
  • Lægemiddelform:
  • pulver til injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Thiopental Life pulver til injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 56535
  • Sidste ændring:
  • 24-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Thiopental Life, pulver til injektionsvæske, opløsning

thiopentalnatrium

Læs denne indlægsseddel grundigt, inden du begynder at bruge dette

lægemiddel, da den indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at

give det til andre. Det kan være skadeligt for andre, selvom de har de samme

symptomer, som du har.

Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller

du får bivirkninger som ikke er nævnt her.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide om Thiopental Life

Sådan bliver du behandlet med Thiopental Life

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1. Virkning og anvendelse

Thiopental Life er et hurtigvirkende thiobarbiturat til intravenøs administration. Det

anvendes til helbedøvelse og vedligeholdelse af helbedøvelse.

Du skal have Thiopental Life som en indsprøjtning. Det vil normalt være en læge

eller sygeplejerske, der giver indsprøjtningen. Lægen kan give dig Thiopental Life for

noget andet. Spørg lægen.

2. Det skal du vide om Thiopental Life

Brug ikke Thiopental Life

Du må ikke få Thiopental Life:

hvis du er allergisk over for thiopental, barbiturater eller et af de øvrige

indholdsstoffer i Thiopental Life (angivet i afsnit 6)

hvis du har svære vejrtrækningsproblemer

hvis du har svær astma (status astmaticus)

hvis du har porfyri (mørkerød urin, kraftige mavesmerter, psykiske forstyrrelser

som f.eks. angst)

Advarsler og forsigtighedsregler

Lægen eller sundhedspersonalet vil være ekstra forsigtig med at behandle dig med

Thiopental Life. Tal med lægen, inden du får Thiopental Life hvis du har:

en alvorlig hjertelidelse

for lavt blodtryk eller er i shock

nedsat nyre- og/eller leverfunktion

nedsat funktion af endokrine kirtler (hypofysen, skjoldbruskkirtlen, binyrerne,

bugspytkirtlen)

forhøjet tryk i hjernen

astma

uræmi (urinforgiftning af blodet)

svær anæmi (blodmangel)

myasthenia gravis (en nervesygdom, som medfører muskelsvækkelse)

inflammation af mund, kæbe og hals.

Brug af anden medicin sammen med Thiopental Life

Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin

eller har brugt det for nylig.

Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet,

naturlægemidler, stærke vitaminer og mineraler samt kosttilskud.

Fortæl det til lægen, hvis du bruger:

aminofyllin (medicin mod astma)

midazolam (beroligende medicin)

stærk smertestillende medicin af typen opioider

probenecid (medicin mod podagra)

sufentanil (smertestillende medicin)

benzodiazepiner (medicin mod angst)

chloralhydrat (medicin mod søvnløshed)

muskelafslappende medicin

valproat og MAO-hæmmere (antidepressiv medicin)

metoclopramid (medicin mod kvalme)

quetiapin (antipsykotisk medicin)

midler, der indeholder perikum

betablokkere og calciumantagonister (medicin mod forhøjet blodtryk)

androgener (medicin til behandling af ufrugtbarhed hos mænd)

medicin mod epilepsi

felodipin (medicin mod for højt blodtryk)

binyrebarkhormoner (antiinflammatorisk medicin)

metronidazol (medicin mod bakterielle infektioner)

perorale antikoagulantia (medicin mod blodpropper)

østrogen (medicin til behandling af overgangsalderen)

perorale antidiabetika (medicin mod sukkersyge)

theophyllin (medicin til behandling af lungesygdomme)

Graviditet, amning og frugtbarhed

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at

blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.

Thiopental Life bør kun gives til gravide, hvis der klart behov for det.

Thiopental udskilles i modermælk. Før Thiopental Life anvendes, bør amning derfor

midlertidigt ophøre (i mindst 12 timer) og brystmælken udmalkes.

Trafik- og arbejdssikkerhed

Patienten må ikke føre motorkøretøj eller betjene maskiner inden for 24 timer efter at

have fået Thiopental Life, eller i en periode, der fastlægges af den ansvarlige læge.

Thiopental Life indeholder natrium

Et hætteglas med Thiopental Life 500 mg indeholder 2,2-2,4 mmol (51-56 mg)

natrium. Et hætteglas med Thiopental Life, 1 000 mg, indeholder 4,4-4,9 mmol

(102-112 mg) natrium. Patienter på natriumfattig diæt skal tage hensyn hertil.

3. Sådan bliver du behandlet med Thiopental Life

Sundhedspersonalet vil give dig Thiopental Life i en dosis, der fastlægges af lægen.

Du vil få thiopental indsprøjtet direkte i en vene (intravenøst).

Hvis du har fået for meget Thiopental Life

Det er usandsynligt at du får for stor en dosis, da sundhedspersonalet tager sig af

administrationen af Thiopental Life.

Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.

L20BI01

4. Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får

bivirkninger.

Almindelige bivirkninger (forekommer hos færre end 10 ud af 100 behandlede):

hjertearytmi (uregelmæssig hjerterytme)

hjerteproblemer

for lavt blodtryk

søvnighed

forsinket opvågnen efter bedøvelsen

åndedrætsbesvær

hyperventilation (abnormt øget vejrtrækning)

synkebesvær

hoste

snorken

rysten

Sjældne bivirkninger (forekommer hos færre end 1 ud af 1 000 behandlede):

allergiske reaktioner som udslæt, vejrtrækningsbesvær, blodtryksfald og

angioødem (akut hævelse af huden).

Thiopental er blevet sat i forbindelse med indberetninger om nedsat kaliumindhold i

blodet under infusionen og forhøjet kaliumindhold i blodet efter ophør af infusionen

af thiopental.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.

Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.

Du eller dine pårørende kan også indberette bivirkninger direkte til

Sundhedsstyrelsen, Axel Heides Gade 1, 2300 København S, websted:

www.meldenbivirkning.dk, e-mail: dkma@dkma.dk.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information

om sikkerheden af dette lægemiddel.

5. Opbevaring

Uåbnet flaske:

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende

opbevaringen.

Efter opløsning:

Opbevares i køleskab (2-8 °C) i højst 24 timer.

Opbevares ved rumtemperatur i højst 6 timer.

Opbevares utilgængeligt for børn.

Brug ikke Thiopental Life efter den udløbsdato, der står på pakningen efter Udl.dato.

Udløbsdatoen er den sidste dag i den nævnte måned.

Spørg på apoteket, hvordan du skal aflevere medicinrester. Af hensyn til miljøet må

du ikke smide medicinrester i afløbet, toilettet eller skraldespanden. Derved skåner

du miljøet.

6. Pakningsstørrelser og yderligere oplysninger

Thiopental Life indeholder:

- Aktivt stof: thiopentalnatrium.

Hvert hætteglas med Thiopental Life, 0,5 g pulver til injektionsvæske, opløsning

indeholder 500 mg thiopentalnatrium.

Hvert hætteglas med Thiopental Life 1 g pulver til injektionsvæske, opløsning

indeholder 1 000 mg thiopentalnatrium.

- Det andet indholdsstof er natriumcarbonat.

2018-01-19

210x297 mm

Udseende og pakningsstørrelser

Hætteglas af glas med prop af brombutylgummi, aluminiumkapsel, i karton.

Pakningsstørrelser:

Thiopental Life, pulver til injektionsvæske, opløsning, 0,5 g: 10x1 hætteglas

Thiopental Life, pulver til injektionsvæske, opløsning, 1 g: 10x1 hætteglas

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Parallelimportør

Life Medical Aps, DK-3660 Stenløse

Ompakning

UAB Entafarma, Klonėnų vs. 1, LT-191 56 Širvintų r. sav., Litauen

Denne indlægsseddel blev senest revideret: september 2017

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Følgende oplysninger er tiltænkt læger og sundhedspersonale:

Fremstilling af opløsninger

Thiopental Life, pulver til injektionsvæske, opløsning, skal fremstilles aseptisk med et

af følgende tre solvenser:

Vand til injektionsvæsker

Natriumchlorid 9 mg/ml (0,9 %)

Glukose, 50 mg/ml (5 %)

De kliniske koncentrationer, der anvendes til intermitterende intravenøs

administration, varierer mellem 2,0 % og 5,0 %. Oftest anvendes en 2,0 % eller

2,5 % opløsning. En 3,4 % opløsning i sterilt vand til injektionsvæsker er isotonisk;

koncentrationer på mindre end 2,0 % i dette solvens anvendes ikke, da de

medfører hæmolyse. Til kontinuerlig intravenøs administration i drop anvendes

koncentrationer på 0,2 % eller 0,4 %. Opløsningerne kan fremstilles ved tilsætning af

thiopental til en 5 % vandig glukoseopløsning eller en 0,9 % opløsning af

natriumchlorid.

BEREGNINGER TIL FORSKELLIGE KONCENTRATIONER

Ønsket koncentration

Mængde, der skal anvendes

mg/ml

g Thiopental Life

ml solvens

Da Thiopental Life ikke er tilsat bakteriostatisk middel, skal der udvises den yderste

omhu ved fremstilling og håndtering for at undgå tilførsel af mikrobielle

kontaminanter. Opløsningerne skal fremstilles frisk og anvendes straks. Når

rekonstituering foretages med henblik på administration til flere patienter, skal ubrugt

opløsning kasseres efter 24 timer. Der må ikke anvendes sterilisering med damp.

Thiopental Life må kun indgives intravenøst. Undgå ekstravasation og intraarteriel

injektion. En person med uddannelse i anæstesi bør konstant være til stede under

administration af lægemidlet. Udstyr til endotrakeal intubering, oxygen og

genoplivningsudstyr skal være umiddelbart for hånden.

Hvis der er synligt bundfald efter opløsning af Thiopental Life, bør opløsningen ikke

anvendes.

Uforligeligheder:

Stabiliteten af opløsninger af Thiopental Life, afhænger af flere faktorer, herunder

det anvendte solvens, opbevaringstemperatur samt kuldioxidindholdet i den luft, der

får adgang til opløsningen. Enhver faktor eller tilstand, der sænker pH (øger

surhedsgraden) af opløsninger med Thiopental Life, øger sandsynligheden for

udfældning af thiopentalsyre. Sådanne faktorer kan være anvendelse af et for surt

solvens og absorption af kuldioxid, der med vand kan danne kulsyre.

Opløsninger af suxamethonium, tubocurarin og andre lægemidler med surt pH bør

ikke blandes med opløsninger af Thiopental Life.

De mest stabile opløsninger er dem, der rekonstitueres i vand og/eller isotonisk

saltvand og/eller glukoseopløsning og opbevares nedkølet og tillukket.

2018-01-19

210x297 mm

19-7-2018

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

16-7-2018

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz® Quality Foods, LLC., is voluntarily recalling select expiration dates of Utz® Carolina Style Barbeque Potato Chips due to undeclared soy allergen. This recall was initiated after learning a certain number of packages were mislabeled. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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

9-7-2018

July 6, 2018: Vero Beach Orthopedic Surgeon Sentenced to Life in Prison Following Conviction for Fentanyl Analog Drug Conspiracy Resulting in Death

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FDA - U.S. Food and Drug Administration

9-7-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids

Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids

FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.

FDA - U.S. Food and Drug Administration

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

3-7-2018

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

2-7-2018

May Flower International Inc. Issues a Allergy Alert on Undeclared Milk Allergens in “3+2 Soda Crackers”

May Flower International Inc. Issues a Allergy Alert on Undeclared Milk Allergens in “3+2 Soda Crackers”

May Flower International Inc. of 5672 49th Place, Maspeth, NY, is recalling its 4.4 ounce packages of “3+2 Soda Crackers” because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

1-7-2018

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Whole Foods Market is voluntarily recalling Whole Foods Market brand oatmeal raisin cookies from stores in eight states because the products contained soy flour that was not listed on the product label. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

23-6-2018

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc., DBA Honey Mama's of Portland, Oregon is recalling 79 Sleeves (948 units) of Oregon Peppermint bars, lot code 112918, because it may contain undeclared Almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

19-6-2018

Golden Star Wholesale  Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

5-6-2018

Shearer’s Foods, LLC Issues an Allergy Alert for Undeclared Milk in Meijer Brand Dill Pickle Flavored Potato Chips

Shearer’s Foods, LLC Issues an Allergy Alert for Undeclared Milk in Meijer Brand Dill Pickle Flavored Potato Chips

Shearer’s Foods, LLC of Massillon, OH is recalling Meijer brand 9.5 ounce packages of Dill Pickle Flavored Potato Chips because they may contain undeclared milk. People who are allergic to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

2-6-2018

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites

Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

1-6-2018

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits

SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared milk allergen. Consumers who are allergic to milk allergen may run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

1-6-2018

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuri...

FDA - U.S. Food and Drug Administration

26-5-2018

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand

Global Commodities, Inc. of Hicksville, NY is recalling 1lb and 0.5lb packages of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt, because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

25-5-2018

Dough-To-Go Issues Allergy Alert on Undeclared Tree Nuts in Zoe’s Vegan Tuxedo Fudge Cookie

Dough-To-Go Issues Allergy Alert on Undeclared Tree Nuts in Zoe’s Vegan Tuxedo Fudge Cookie

Dough-to-Go of Santa Clara, CA is recalling 20 cases of cookies because they may contain undeclared tree nuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

24-5-2018

New Seasons Market LLC Issues Allergy Alert on Undeclared Egg in Mini Butter Croissants and Mini Chocolate Croissants

New Seasons Market LLC Issues Allergy Alert on Undeclared Egg in Mini Butter Croissants and Mini Chocolate Croissants

New Seasons Market LLC is recalling NSM 8-pack mini butter croissants and 8-pack mini chocolate croissants because they contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-5-2018

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens and this is not declared on the package. Individuals who have an allergy or severe sensitivity to milk, soy, wheat or cashews run the risk of serious or life-threatening allergic reaction if they consume these products

FDA - U.S. Food and Drug Administration

18-5-2018

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

12-5-2018

Sugarfina, Inc.  Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product

Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product

Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

3-5-2018

Voluntary Recall of Certain Golden Flake, Good Health, UTZ and Weis Brand Tortilla Chips Because of Possible Milk Allergen

Voluntary Recall of Certain Golden Flake, Good Health, UTZ and Weis Brand Tortilla Chips Because of Possible Milk Allergen

Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-4-2018

UPDATED: Van’s Foods Voluntarily Recalls Gluten Free Waffles Due to Gluten, Undeclared Wheat & Undeclared Milk

UPDATED: Van’s Foods Voluntarily Recalls Gluten Free Waffles Due to Gluten, Undeclared Wheat & Undeclared Milk

Van’s Foods is voluntarily recalling Van’s Gluten Free Waffles with a lot code date of #A640234710–WL2, BEST BY AUG 22, 2018 and UPC 0 89947 30206 4. The products are being recalled because a limited number of the wrong packaging were used during the production of Van’s Belgian Waffles. The product inadvertently packaged in the Van’s Gluten Free Waffle box contains gluten, undeclared wheat and undeclared milk. People who have an allergy or severe sensitivity to milk, wheat or gluten run the risk of serio...

FDA - U.S. Food and Drug Administration

27-4-2018

Ethnic Foods Inc. Issues Allergy Alert on Undeclared Peanuts in “Bhavnagri Mix”

Ethnic Foods Inc. Issues Allergy Alert on Undeclared Peanuts in “Bhavnagri Mix”

Ethnic Foods Inc. of 76 South Bayles Avenue, Port Washington, NY 11050, is recalling its 19 ounce package of Bhavnagri Mix snack mix because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

25-4-2018

Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder

Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder

Labrada Nutrition of Houston, TX, is recalling specific lots of its "LeanPro8" Protein Powder because they may contain undeclared egg protein. People who have allergies to egg protein run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

20-4-2018

Eataly USA Issues Allergy Alert on Undeclared Walnuts in Artichoke Spread

Eataly USA Issues Allergy Alert on Undeclared Walnuts in Artichoke Spread

Eataly USA of New York City, New York is recalling Eataly Artichoke Spread, because it may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

13-4-2018

Guixens Food Group Issues Allergy Alert on Undeclared Sulfites in La Marinera Brand Dried Yellow Potatoes

Guixens Food Group Issues Allergy Alert on Undeclared Sulfites in La Marinera Brand Dried Yellow Potatoes

Guixens Food Group, Inc., of Miami, FL, is voluntarily recalling its ten-ounce packages of La Marinera Brand Dried Yellow Potatoes because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

12-4-2018

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat and fish. People who have an allergy or severe sensitivity to these allergens may run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

11-9-2017

DKMA Update

DKMA Update

Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

Danish Medicines Agency

13-7-2016

BLINCYTO (blinatumomab) - Risk of Pancreatitis

BLINCYTO (blinatumomab) - Risk of Pancreatitis

There have been reported cases of life-threatening, sometimes fatal pancreatitis associated with the use of BLINCYTO (blinatumomab) in clinical trial and post-market settings.

MedEffect Canada

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish Medicines Agency

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety