31/01/2012

Thiopental injection - electronic Medicines Compendium (eMC) - print friendly

A chimede Pha ma UK L d
250 So h Oak Wa , G een Pa k, Reading, RG2 6UG, UK Telephone: +44 (0)118 931 5050 Fa : +44 (0)118 931 5056 WWW: http:// .archimedespharma.com Before ou contact this compan : of en e e al companie ill ma ke medicine i h he ame ac i e ing edien . Plea e check ha hi i he co ec compan befo e con ac ing hem. Wh ? S mma of P od c Cha ac e i ic la pda ed on he eMC: 03/11/2010

Thiopental injection

1. NAME OF THE MEDICINAL PRODUCT

Thiopen al Sodi m 500mg Po de fo Sol ion fo Injec ion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ial con ain 500mg Thiopen al Sodi m of e cipien ee ec ion 6.1 Fo a f ll li

3. PHARMACEUTICAL FORM
F ee e-d ied po de fo ol ion fo injec ion in a ial.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications 1. Thiopen al odi m i ed fo he ind c ion of gene al anae he ia and i al o ed a an adj nc o p o ide h pno i d ing balanced anae he ia i h o he anae he ic agen , incl ding analge ic and m ela an . 2. Thiopen al odi m i al o ed a an adj nc fo con ol of con incl ding ho e ca ed b local anae he ic . l i e di o de of a io ae iolog , cle

3. Thiopen al odi m ha no been ed o ed ce he in ac anial p e in ac anial p e e, if con olled en ila ion i p o ided. 4.2 Posolog In a eno and method of administration injec ion.

e in pa ien

i h inc ea ed

Thiopen al Sodi m 500mg Injec ion i admini e ed in a eno l no mall a a 2.5% ol ion. On occa ion i ma be admini e ed a a 5% / ol ion (500mg in 10ml). The in a eno injec ion p epa a ion ho ld be ed af e Injec ion , all o p od ce a 2.5% / ol ion and hi U e in anae he ia

(500mg in 20ml)

econ i ion of he e ile po de i h Wa e fo ho ld be di ca ded af e e en ho .

No mal do age fo he ind c ion of anae he ia i 100mg o 150mg injec ed o e 10 o 15 econd . If nece a a epea do e of 100mg o 150mg ma be gi en af e one min e. No fi ed do age ecommenda ion fo he in a eno injec ion can be gi en, ince he do age ill need o be ca ef ll adj ed acco ding o he pa ien ' e pon e. Fac o ch a age, e , and eigh of he pa ien ho ld be aken in o con ide a ion. Thiopen al odi m eache effec i e concen a ion in he b ain i hin 30 econd and anae he ia i no mall p od ced i hin one min e of an in a eno do e. Ad l 100mg o 150mg in a eno l o e 10 o 15 econd , no mall a a 2.5% / ol ion.
1/5

www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=1433

31/01/2012

Thiopental injection - electronic Medicines Compendium (eMC) - print friendly

A T 500 . 70

100

150

. .T '

200

300

(8

12

2.5%

Children 2 7 / 2 7 .T / , 10 15 .T 7 / , . 2 7 / 2.5% / .A '

Elderl S U 75 125 .O U I 1.5 3 / . (3 .F . 5 , 2.5% / ) , .

4.3 Contraindications T C P 4.4 Special T When particular caution is required S , . Dose reduction required R . . , , , . , , , , , , , :, arnings and precautions for use , . .A . . , , . ,

),

Use in hepatic and renal disease T .B .R

Use with other medications (see also section 4.5) and in underl ing disease T P , , . Increased doses I
www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=1433 2/5

.R , , MAOI

. .P

31/01/2012

Thiopental injection - electronic Medicines Compendium (eMC) - print friendly

.U E travasation E . Accidental intra-arterial injection A .A 4.5 Interaction T I AC E A A A :P .T A A -II -II :G . A A :I :P .S .H , , . . . . . : :E :E :P , :E . C NS , , . :M . :E . ; ; : . :E :E . .O . AC E . .I . .T 5% / .T

ith other medicinal products and other forms of interaction ( 4.4).

MAOI .

.T

B D D G M M N P V T B H :E :E

:M

C NS . :A

S J

' W
3/5

www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=1433

31/01/2012

Thiopental injection - electronic Medicines Compendium (eMC) - print friendly

di

. and lactation i . The ef e, b ea i f a ae he ia. I eg a c a h gh he di he c i icia

4.6 Pregnanc

Thi e a di eadi c e he ace a ba ie a d a a ea i b ea feedi g h d be e a i e ded b ea i e e ed bef e he i d c ha bee h ha hi e a di ca be ed i h ad e e effec d i g a d e h d e ceed 250 g. H e e , he c ide i g e f hi e a h d e he d g he he e ec ed be efi eigh a e ia i . 4.7 Effects on abilit P di to drive and use machines a d eda i d i e a be ged a d e achi e , e ecia - a ie i hi

e a i e e ig , di ie a i h d he ef e be ad i ed

gi e hi he fi 24

e a 36 h

4.8 Undesirable effects La ea E ce A P c gea i i i e d a a cc ad i ed e a e a d e , ge he i h c ghi g e hi e a di a e f ihh fe e ,b he ee . hi e i g a cc a d he e e ia, a be e i e d i e i e , ia a d ee i g, d i g he i d c i e a e d c . f d ce eb a i ai e . ced e. F hi

cia ed e i

i i ia fa i b f e ai e i a da

ii gi i f e e ia. a ie eac i de ed

O he e a i e c ha bee ed i e de A e gic eac i B ch a , , e e i i a

e a i e effec . a dh e i e e a d e

i c de a ii i

a ai e, fa ig e, a d di a e e ed. h ia

. De i i

ha e bee e i

ca dia de

ca diac a h

cc

Headache i a 4.9 Overdose

i h he

f ba bi

a e a ae he ic .

O e d age d ce ac e e i a be a ificia e i a i , e i g

de e i , h e i , ci c a f he a ie ' head a d i f i f

fai e a d a ea. T ea a a e e a de .

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacod namic properties Thi e a di i a h -ac i g b i ed ba bi a e ha i e i id b e ha he g ba bi a e . The d g e e ib de e e he ac i i f a e ci ab e i e . The C NS i a ic a e ii e a d a a ge e a a ae he ia ca be achie ed i h hi e a di ih ig ifica effec e i he a i e . Thi A e e a di ac h gh he C NS i h a ic a ac i i i . The ba bi a e e e diffe e effec a ic a ic ga g ia f he e i he a e e a e a de f

he e e ce ha ic e ic a ac i a i g i i , h e de e de GABA. e ed.

5.2 Pharmacokinetic properties F i gi a e ad i i a i , c 30 i e af e a i g e d e. Ra id edi ib i i he i e . a , a i ci a e e cc cc i hi 30 ec d a d i be c a c a a ea f he b ai f i ed f ed b 20

Thi e a di e ab i e a e d ai f ac i

g b d a a ei , hich i i ac i e a d a e he e c e ed. Thi e ha e a gei i ai ha e.

ai e c e i h gh he id e . The a di , he ef e, hi ha i g a h

5.3 Preclinical safet The e a e he ec i

data hich a e addi i a ha a ead i c ded i

ec i ica da a f e e a ce he e c ibe f he S a f P d c C ha ac e i ic .

6. PHARMACEUTICAL PARTICULARS
6.1 List of e cipients
www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=1433 4/5

31/01/2012

Thiopental injection - electronic Medicines Compendium (eMC) - print friendly

None 6.2 Incompa ibili ie Solutions of thiopental sodium injection have a pH of 10 to 11 and are strongly alkaline in order to maintain stability. Solutions are incompatible with acid, acidic salts and solutions such as pethidine, morphine and promethazine. 6.3 Shelf life 48 months. 6.4 Special p eca ion fo o age

Do not store above 25 C . Store reconstituted solution between 2 C to 8 C in an upright position and use within 7 hours. Use once following reconstitution and discard any residue. 6.5 Na e and con en of con aine

20ml Type III clear glass vials with 20mm bromylbutyl caoutchouc siliconised rubber closures. Pack size: 1, 10 or 25 vials per pack. Not all pack sizes may be marketed 6.6 Special p eca Not applicable. ion fo di po al and o he handling

7. MARKETING AUTHORISATION HOLDER

Archimedes Pharma UK Limited 250 South Oak Way Green Park Reading Berkshire RG2 6UG UK

8. MARKETING AUTHORISATION NUMBER(S)

PL 12406/0014

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

5 April 1999

10. DATE OF REVISION OF THE TEXT

July 2010 THII500-SPC 08

www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=1433

5/5