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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 No Yes BI-Diecut-Legendcase Issue date of artwork: 15/Juni/2011 No Yes Print colors: PAN Black No 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):