Download Effortil® 10 mg/1 ml injection

SCHEDULING STATUS: S2
PROPRIETARY NAME (and dosage form):
Effortil®
10 mg/1 ml
injection
abcd
PHARMACOLOGICAL CLASSIFICATION:
A 5.1 Adrenomimetics (sympathomimetics)
PHARMACOLOGICAL ACTION:
EFFORTIL 10 mg/1 ml, in pharmacological terms is
regarded as a sympathomimetic.
Recent investigations allow for a more precise
description as a cardioselective drug.
This term deserves some explanation:
EFFORTIL 10 mg/1 ml has a mild stimulating effect
on peripheral alpha-adreno­ceptors (approximately
1/10 of that of noradrenaline), a mild stimulating
effect of beta2-adrenoceptors, and a prominent effect
on beta1-adrenoceptors. The pharmacologically
assessed action on adrenoceptors results in a number
of typical cardiovascular changes. They are: increase in
venous return, increase in stroke volume and cardiac
output, unchanged heart rate, slight drop in peripheral
arterial resistance, relaxation in precapillary sphincters
and increase in trans­capillary flow. By the same token,
the circulation time is shortened. The combination
of the above cardiovascular actions causes improved
tissue perfusion. Based on the above considerations,
EFFORTIL 10 mg/1 ml can be used in all conditions
where a decreased tissue perfusion is assumed.
One of the leading symp­toms of reduced tissue
perfusion is a drop in blood pressure.
INDICATIONS:
To correct hypotension in:
a) circulatory failure
b) during anaesthesia
c) post-operatively
Children under 1 year
4 years
8 years
13 years
– ½ to 1 ampoule (10 mg) daily
– up to 1½ ampoules daily
– 1 to 2 ampoules daily
– 1½ to 3 ampoules daily
Adults
– 3 to 6 ampoules daily
For infusion physiological saline solution, lactated
Ringer’s solution, 5 % glucose solution or 10 % xylitol
solution without any further additives should be used.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Occasionally palpitations, tachycardia, anxiety,
sweating, insomnia, nausea, tremor and
a sensation of pressure in the head may occur.
In hypersensitive patients occurrence of anginal pain,
cardiac arrhythmias and unwanted increase in blood
pressure cannot be excluded. The dose of EFFORTIL
should be reduced in patients experiencing these
symptoms.
Special Precautions:
Stenosis of the heart valves or central arteries must
be ruled out as a cause of hypotension before starting
treatment with EFFORTIL.
Caution should be exercised in patients with
tachycardia, cardiac arrhythmias or severe
cardiovascular disorders.
KNOWN SYMPTOMS OF OVERDOSAGE AND
PARTICULARS OF ITS TREATMENT:
Acute overdosage intensifies the adverse effects
previously described.
In babies and small children, overdosage may cause
central respiratory paralysis and coma.
CONTRA-INDICATIONS:
EFFORTIL is contra-indicated in patients who are
hypersensitive to etilefrine.
EFFORTIL should not be given to patients with
thyrotoxicosis, phaeochromocytoma, narrowangle glaucoma, prostatic hypertrophy with urinary
retention, hypertension, coronary heart failure and
hypertrophic obstructive cardio­myopathy.
code reading direction
code Laetus E128
INTERACTIONS:
The effects of EFFORTIL may be enhanced by
concurrent administration of guanethidine,
mineralocorticoids, sympathomimetics or any
substance with sympathomimetic activity
(like tricyclic antidepressants, MAO inhibitors).
Halogenated aliphatic hydrocarbons may enhance
the effects of sympathomimetic agents on the
heart and thus lead to the development of cardiac
arrhythmias.
Adrenergic blocking agents (α-blockers and
β-blockers) may partially or completely abolish the
effects of etilefrine.
72,5 mm
indicates the point of reference
for the code
Áurea
Vázquez
The recommended doses are as follows:
please use the text color
for the registration mark*
COMPOSITION:
Each 1 ml ampoule contains etilefrine hydro­chloride
10 mg.
PREGNANCY AND LACTATION:
EFFORTIL is contra-indicated during the first trimester
of pregnancy. Safety of its use during the second and
third trimesters has not yet been established.
EFFORTIL may impair uteroplacental perfusion and
cause uterine relaxation. Entering of the drug into
breast milk cannot be excluded, therefore EFFORTIL
should not be administered during lactation.
DOSAGE AND DIRECTIONS FOR USE:
EFFORTIL 10 mg/1 ml can be administered as
intravenous injection or drip infusion, subcutaneously
and intramuscularly.
Treatment:
Symptomatic and supportive treatment should
be given as appropriate.
Intensive care measures should be taken in
cases of severe overdosage.
IDENTIFICATION:
A clear, colourless solution in 1 ml amber glass
ampoules.
PRESENTATION:
Packs of 5 x 1 ml ampoules, each containing
10 mg EFFORTIL.
STORAGE INSTRUCTIONS:
Store below 30 °C in a dry place and protect
from light.
Keep out of reach of children.
REGISTRATION NUMBER:
F/5.1/197
NAME AND BUSINESS ADDRESS OF THE HOLDER OF
THE CERTIFICATE OF REGISTRATION:
Ingelheim Pharmaceuticals (Pty) Ltd
Pine Avenue, Randburg, South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 August 1973
BOTSWANA Reg. No. B9305060
S2
NAMIBIA Reg. No. 90/5.1/00459
NS1
22D523
Firmado digitalmente por Áurea
Vázquez
Nombre de reconocimiento (DN):
cn=Áurea Vázquez, c=ES, o=BIESA,
ou=CMA, [email protected]
Fecha: 2011.06.21 10:43:44 +02'00'
File information
Mandatory in
Technical information
TD
Printfile
a = Batch No.
b = Expiry date
Issue date of TD:
20-05-2011
Yes
Yes
c = Manufacturing date
d = Price/Sample/Clinic
PPM SKU:
P001364
No
Yes
Technical colors
PPM SKU version: 005
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Yes
BI-Diecut-Legendcase
Issue date of artwork:
15/Juni/2011
No
Yes
Print colors:
PAN Black
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Yes
Free area
Additional Requirements of Packaging site
* Cutting mark: Use the darkest print color or use the same color of text.
Mat. No. Pack. Site:
22D523
Legend case version:
V3.0 01/JUN/2010 (please do not change or remove it)
No
Yes
** Page number: Use the darkest print color or use the same color of text.
TD file: TMP_PI_148x315_2c_AMP
Template number: 0000-26-01 / 0000-27-01
Gluepoints
SKEDULERINGSTATUS: S2
Effortil®
10 mg/1 ml
inspuiting
FARMAKOLOGIESE WERKING:
Farmakologies word EFFORTIL 10 mg/1 ml
as ’n simpatomimetikum beskou. Onlangse werk het
daartoe gelei dat EFFORTIL as ’n kardioselektiewe middel beskou word.
Hierdie beskrywing verdien nadere toeligting.
EFFORTIL 10 mg/1 ml het ’n effense stimulerende
effek op perifere alfa-adrenoseptore (ongeveer
1/10 de van dié van noradrenalien), ’n effense
stimulerende effek op beta2-adrenoseptore, en ’n
besliste effek op beta1-adrenoseptore.
Hierdie farmakologies bepaalde werking op
adrenoseptore het ’n aantal tipiese kardiovaskulêre
veranderinge tot gevolg. Hulle is: ’n toename in
veneuse terugvloei, verbeterde slagvolume en
hartomset, onver­anderde harttempo, ’n effense
afname in perifere arteriële weerstand, ontspanning
van pre-kapillêre sfinkters en ’n toename in transkapillêre vloei. Sodoende word sirkulasietyd
verkort.
Bogenoemde kardiovaskulêre effekte het ’n verbeterde
weefselperfusie tot gevolg.
Gegrond op bogenoemde oorwegings kan EFFORTIL
10 mg/1 ml aanbeveel word in alle toestande waar
’n verminderde weefselperfusie aangetref word.
Een van die voorste simptome van ’n verminderde
weefselperfusie is ’n afname in bloeddruk.
INDIKASIES:
Om hipotensie te korrigeer in:
(a) bloedsomloopversaking
(b) tydens narkose
(c) na operasies
please use the text color
for the registration mark*
KONTRA-INDIKASIES:
EFFORTIL is teenaangewys in pasiënte wat
hipersensitief is vir etielefrien.
EFFORTIL moet nie aan pasiënte met tirotoksikose,
feochromositoom, nou-hoek gloukoom, prostatiese
hipertrofie met urienretensie, hipertensie, koronêre
hartversaking en hipertrofiese obstruktiewe
kardiomiopatie gegee word nie.
WISSELWERKING MET ANDER MIDDELS:
Die effekte van EFFORTIL kan versterk word
deur die gelyktydige inname van guanetidien,
mineralokortikoïede, simpatomimetika of enige
middel met simpatomimetiese werking
(soos trisikliese antidepressante,
MAO inhibeerders).
Halogeneerde alifatiese koolwaterstowwe kan die effek
van simpatomimetiese middels op die hart versterk en
kan dus lei tot die ontwikkeling van kardiese aritmië.
Adrenergiese blokkeerders (α-blokkeerders en
β-blokkeerders) kan die effekte van etielefrien
gedeeltelik of heeltemal ophef.
SWANGERSKAP EN LAKTASIE:
EFFORTIL is teenaangedui gedurende die eerste
trimester van swangerskap. Veiligheid van die gebruik
daarvan gedurende die tweede en derde trimesters is
nog nie vasgestel nie.
EFFORTIL kan uteroplasentale perfusie belemmer en
uteriene verslappping veroorsaak.
Uitskeiding van die middel in borsmelk kan nie
uitgesluit word nie en dus moet EFFORTIL nie tydens
laktasie geneem word nie.
Kinders jonger as 1 jaar
4 jaar
8 jaar
13 jaar
– ½ tot 1 ampul (10 mg) daagliks
– tot 1½ ampulle daagliks
– 1 tot 2 ampulle daagliks
– 1½ tot 3 ampulle daagliks
Volwassenes
– 3 tot 6 ampulle daagliks
Vir infusie moet fisiologiese soutoplossing,
Ringers laktaatoplossing, 5 % glukose-oplossing
of 10 % xilitol oplossing sonder verdere
bymiddels gebruik word.
NEWE-EFFEKTE EN SPESIALE
VOORSORGMAATREËLS:
Newe-effekte:
Af en toe kan hartkloppings, tagikardie, angs, sweet,
slaaploosheid, naarheid, bewing en ’n sensasie van
druk in die kop voorkom.
In hipersensitiewe pasiënte kan anginale pyn,
kardiese aritmië en ’n ongewenste verhoging in
bloeddruk nie uitgesluit word nie. Die dosis van
EFFORTIL behoort verlaag te word in pasiënte wat
sulke simptome ondervind.
Spesiale voorsorgmaatreëls:
Stenose van die hartkleppe of sentrale arterië moet
uitgesluit word as ’n oorsaak van hipotensie voordat
daar met EFFORTIL behandeling begin word.
Versigtigheid moet aan die dag gelê word by
pasiënte met tagikardie, kardiese aritmië of ernstige
kardiovaskulêre afwykings.
BEKENDE SIMPTOME VAN OORDOSERING EN
BESONDERHEDE VAN BEHANDELING DAARVAN:
Akute oordosering lei tot versterking van die neweeffekte wat reeds hierbo beskryf is.
In babas en jong kinders kan oordosering
respiratoriese paralise en koma veroorsaak.
Behandeling:
Simptomatiese en ondersteunde behandeling
moet gegee word soos nodig.
Intensiewe sorg moet gegee word in gevalle van
erge oordosering.
IDENTIFIKASIE:
’n Helder, kleurlose oplossing in 1 ml amberkleurige
glas ampulle.
AANBIEDING:
Verpakkings van 5 x 1 ml ampulle wat elk 10 mg
EFFORTIL bevat.
BERGINGSAANWYSINGS:
Bewaar onder 30 °C in ’n droë plek en beskerm teen
lig. Hou buite bereik van kinders.
REGISTRASIENOMMER:
F/5.1/197
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN
DIE REGISTRASIESERTIFIKAAT:
Ingelheim Pharmaceuticals (Edms) Bpk
Pinelaan, Randburg, Suid-Afrika
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
13 Augustus 1973
22D523
code Laetus E128
FARMAKOLOGIESE KLASSIFIKASIE:
A 5.1 Adrenomimetika (simpatomimetika)
DOSIS EN GEBRUIKSAANWYSINGS:
EFFORTIL 10 mg/1 ml kan as ’n intraveneuse
inspuiting of drupinfusie, onderhuids of binnespiers
toegedien word.
Die aanbevole daaglikse dosisse is soos volg:
code reading direction
SAMESTELLING:
Elke 1 ml ampul bevat etielefrienhidrochloried
10 mg.
abcd
72,5 mm
indicates the point of reference
for the code
EIENDOMSNAAM (en doseervorm):