150057170 Fastway (PC 2458) - Dr Reddy’s · FASTWAY 180: Pink coloured, oval shaped, biconvex...
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SCHEDULING STATUS PROPRIETARY NAME (AND DOSAGE FORM) FASTWAY 120 (tablets) FASTWAY 180 (tablets) COMPOSITION FASTWAY 120: Each tablet contains fexofenadine hydrochloride 120 mg FASTWAY 180: Each tablet contains fexofenadine hydrochloride 180 mg Contains mannitol (sugar). PHARMACOLOGICAL CLASSIFICATION A 5.7.1 Antihistaminics PHARMACOLOGICAL ACTION Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective histamine H -receptor 1 antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6 hours and lasting 24 hours. Pharmacokinetics Fexofenadine is absorbed into the body following oral administration, with T occurring at approximately 1 – 3 hours post dose. The mean C value max max was approximately 427 ng/ml and 494 ng/ml following the administration of a 120 mg and 180 mg dose once daily, respectively. The volume of distribution is 5,4 – 5,8 ℓ/kg. Fexofenadine does not cross the blood brain barrier. Fexofenadine is 60 - 70 % plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5 % of the total dose is metabolised, mostly by the intestinal mucosa, with only 0,5 – 1,5 % of the dose undergoing hepatic biotransformation), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 - 15 hours, after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion (faeces), while up to 10 % of the ingested dose is excreted unchanged through the urine. Effect of age In older subjects (≥ 65 years old), peak plasma levels of fexofenadine were 99 % greater than those observed in normal volunteers (< 65 years old). Mean elimination half-lives were similar to those observed in normal volunteers. Renal impairment In patients with mild (creatinine clearance 41 – 80 ml/min) to severe (creatinine clearance 11 – 40 ml/min) renal impairment, peak plasma levels of fexofenadine were 87 % and 111 % greater, respectively, and mean elimination half-lives were 59 % and 72 % longer, respectively, than observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance ≤ 10 ml/min) were 82 % greater and half-life was 31 % longer than observed in normal volunteers. INDICATIONS FASTWAY 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR). FASTWAY 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU). CONTRA-INDICATIONS Safety in pregnancy and lactation has not been established. (See “WARNINGS” ). The safety and efficacy of FASTWAY has not been studied in children under the age of 12 years. Patients with known hypersensitivity to FASTWAY or any of its ingredients. WARNINGS There is only limited data for the use in elderly and renally or hepatically impaired patients. FASTWAY should be administered with care in these special risk groups. FASTWAY has been detected in breast milk. FASTWAY may affect the ability to drive or operate machinery. INTERACTIONS Interaction with other medicaments and other forms of interaction FASTWAY does not undergo hepatic biotransformation. Co- administration of FASTWAY with erythromycin or ketoconazole has been found to result in a 2 - 3 times increase in the level of FASTWAY in plasma. The changes were not accompanied by any effects on the QT- interval and were not associated with any increase in adverse events compared to the drugs given individually. The increase in plasma levels of FASTWAY observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively. No interaction between FASTWAY and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to FASTWAY, causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of FASTWAY and aluminium and magnesium hydroxide containing antacids. PREGNANCY AND LACTATION There is no experience with FASTWAY in pregnant women. FASTWAY should not be taken during pregnancy or lactation. DOSAGE AND DIRECTIONS FOR USE Adults and children aged 12 years and over Chronic idiopathic urticaria (CIU): One 180 mg tablet daily. Seasonal allergic rhinitis (SAR): One 120 mg tablet daily. Children under 12 years of age The efficacy and safety of FASTWAY has not been studied in children under 12. Special risk groups (See “WARNINGS”) Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. SIDE-EFFECTS AND SPECIAL PRECAUTIONS Side-effects Infections and infestations Common : Viral infections such as cold or flu Nervous system disorders Common: Headache, drowsiness, dizziness Common: Fatigue Rare: Insomnia, nervousness, sleep disorders, paranoia Respiratory, thoracic and mediastinal disorders Common: Sinusitis Gastrointestinal disorders Common: Nausea, dyspepsia Skin and subcutaneous tissue disorders Rare: Rash, urticaria, pruritus Reproductive system and breast disorders Common: Dysmenorrhoea Other Rare: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis Special Precautions FASTWAY lacks sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants. (See “Pharmacokinetics”, “INTERACTIONS” and “WARNINGS”). KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Most reports of FASTWAY overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed drug. Haemodialysis does not effectively remove FASTWAY from blood. IDENTIFICATION FASTWAY 120: Pink coloured, oval shaped, biconvex film coated tablets debossed with 'FXF' on one side and '120' on other side. FASTWAY 180: Pink coloured, oval shaped, biconvex film coated tablets debossed with 'FXF' on one side and '180' on other side. PRESENTATION FASTWAY 120: White opaque PVC/PE/PVDC blisters of 10 tablets are packed into cartons of 10 or 30 tablets. FASTWAY 180: White opaque PVC/PE/PVDC blisters of 10 tablets are packed into cartons of 10 or 30 tablets. STORAGE INSTRUCTIONS Store at or below 25 °C. Protect from light. Keep blisters in carton until required for use. KEEP OUT OF REACH OF CHILDREN REGISTRATION NUMBERS FASTWAY 120: 41/5.7.1/0319 FASTWAY 180: 41/5.7.1/0320 NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE REGISTRATION CERTIFICATE Dr. Reddy's Laboratories (Pty) Limited The Place South Wing 1 Sandton Drive Sandton 2196 South Africa DATE OF PUBLICATION OF THIS PACKAGE INSERT August 2007 S2 Fastway South Africa 150057170 Page 1 of 2 250 - 150 mm NOT TO BE PRINTED VERSION : 2 (20-06-2014) Corrections done NOT TO BE PRINTED VERSION : 3 (09-07-2014) Corrections done NOT TO BE PRINTED VERSION : 4 (17-07-2014) Corrections done Version No : 1 (Dt: 20-06-2014) PANTONE CODES Black C 40% of black C Dimensions : LxW (250-150 mm) Folded Size (150 x 40 mm) Version No : 4
Transcript of 150057170 Fastway (PC 2458) - Dr Reddy’s · FASTWAY 180: Pink coloured, oval shaped, biconvex...
SCHEDULING STATUS
PROPRIETARY NAME (AND DOSAGE FORM)FASTWAY 120 (tablets)FASTWAY 180 (tablets)
COMPOSITIONFASTWAY 120: Each tablet contains fexofenadine hydrochloride 120 mgFASTWAY 180: Each tablet contains fexofenadine hydrochloride 180 mgContains mannitol (sugar).
PHARMACOLOGICAL CLASSIFICATIONA 5.7.1 Antihistaminics
PHARMACOLOGICAL ACTIONFexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective histamine H -receptor 1
antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6 hours and lasting 24 hours.
PharmacokineticsFexofenadine is absorbed into the body following oral administration, with T occurring at approximately 1 – 3 hours post dose. The mean C value max max
was approximately 427 ng/ml and 494 ng/ml following the administration of a 120 mg and 180 mg dose once daily, respectively. The volume of distribution is 5,4 – 5,8 ℓ/kg. Fexofenadine does not cross the blood brain barrier.
Fexofenadine is 60 - 70 % plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5 % of the total dose is metabolised, mostly by the intestinal mucosa, with only 0,5 – 1,5 % of the dose undergoing hepatic biotransformation), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 - 15 hours, after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion (faeces), while up to 10 % of the ingested dose is excreted unchanged through the urine.
Effect of ageIn older subjects (≥ 65 years old), peak plasma levels of fexofenadine were 99 % greater than those observed in normal volunteers (< 65 years old). Mean elimination half-lives were similar to those observed in normal volunteers.
Renal impairmentIn patients with mild (creatinine clearance 41 – 80 ml/min) to severe (creatinine clearance 11 – 40 ml/min) renal impairment, peak plasma levels of fexofenadine were 87 % and 111 % greater, respectively, and mean elimination half-lives were 59 % and 72 % longer, respectively, than observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance ≤ 10 ml/min) were 82 % greater and half-life was 31 % longer than observed in normal volunteers.
INDICATIONSFASTWAY 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).
FASTWAY 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU).
CONTRA-INDICATIONSSafety in pregnancy and lactation has not been established. (See “WARNINGS” ).The safety and efficacy of FASTWAY has not been studied in children under the age of 12 years.Patients with known hypersensitivity to FASTWAY or any of its ingredients.
WARNINGSThere is only limited data for the use in elderly and renally or hepatically impaired patients. FASTWAY should be administered with care in these special risk groups. FASTWAY has been detected in breast milk. FASTWAY may affect the ability to drive or operate machinery.
INTERACTIONSInteraction with other medicaments and other forms of interactionFASTWAY does not undergo hepatic biotransformation. Co-administration of FASTWAY with erythromycin or ketoconazole has been found to result in a 2 - 3 times increase in the level of FASTWAY in plasma. The changes were not accompanied by any effects on the QT- interval and were not associated with any increase in adverse events compared to the drugs given individually. The increase in plasma levels of FASTWAY observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
No interaction between FASTWAY and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to FASTWAY, causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of FASTWAY and aluminium and magnesium hydroxide containing antacids.
PREGNANCY AND LACTATIONThere is no experience with FASTWAY in pregnant women.FASTWAY should not be taken during pregnancy or lactation.
DOSAGE AND DIRECTIONS FOR USEAdults and children aged 12 years and overChronic idiopathic urticaria (CIU): One 180 mg tablet daily.Seasonal allergic rhinitis (SAR): One 120 mg tablet daily.
Children under 12 years of ageThe efficacy and safety of FASTWAY has not been studied in children under 12.
Special risk groups (See “WARNINGS”)Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Infections and infestationsCommon : Viral infections such as cold or flu
Nervous system disorders
Common: Headache, drowsiness, dizzinessCommon: FatigueRare: Insomnia, nervousness, sleep disorders, paranoia
Respiratory, thoracic and mediastinal disordersCommon: Sinusitis
Gastrointestinal disordersCommon: Nausea, dyspepsia
Skin and subcutaneous tissue disordersRare: Rash, urticaria, pruritus
Reproductive system and breast disordersCommon: Dysmenorrhoea
OtherRare: Hypersensitivity reactions with manifestations such as
angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis
Special PrecautionsFASTWAY lacks sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants. (See “Pharmacokinetics”, “INTERACTIONS” and “WARNINGS”).
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTMost reports of FASTWAY overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed drug. Haemodialysis does not effectively remove FASTWAY from blood.
IDENTIFICATION
FASTWAY 120: Pink coloured, oval shaped, biconvex film coated tablets debossed with 'FXF' on one side and '120' on other side.
FASTWAY 180: Pink coloured, oval shaped, biconvex film coated tablets debossed with 'FXF' on one side and '180' on other side.
PRESENTATION
FASTWAY 120: White opaque PVC/PE/PVDC blisters of 10 tablets are packed into cartons of 10 or 30 tablets.
FASTWAY 180: White opaque PVC/PE/PVDC blisters of 10 tablets are packed into cartons of 10 or 30 tablets.
STORAGE INSTRUCTIONSStore at or below 25 °C. Protect from light. Keep blisters in carton until required for use.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBERS
FASTWAY 120: 41/5.7.1/0319
FASTWAY 180: 41/5.7.1/0320
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THEREGISTRATION CERTIFICATEDr. Reddy's Laboratories (Pty) LimitedThe Place South Wing 1 Sandton Drive Sandton 2196 South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERTAugust 2007
S2
Fastway South Africa 150057170 Page 1 of 2
250 - 150 mm
NOT TO BE PRINTEDVERSION : 2 (20-06-2014)Corrections done
NOT TO BE PRINTEDVERSION : 3 (09-07-2014)Corrections done
NOT TO BE PRINTEDVERSION : 4 (17-07-2014)Corrections done
Version No : 1 (Dt: 20-06-2014)
PANTONE CODES
Black C
40% of black C
Dimensions : LxW (250-150 mm)Folded Size (150 x 40 mm)Version No : 4
SKEDULERINGSTATUS
EIENDOMSNAAM (EN DOSEERVORM)
FASTWAY 120 (tablette)
FASTWAY 180 (tablette)
SAMESTELLING
FASTWAY 120: Elke tablet bevat feksofenadienhidrochloried 120 mg
FASTWAY 180: Elke tablet bevat feksofenadienhidrochloried 180 mgBevat mannitol (suiker).
FARMAKOLOGIESE KLASSIFIKASIEA 5.7.1 Antihistamiene
FARMAKOLOGIESE WERKINGFeksofenadienhidrochloried is 'n farmakologiese aktiewe metaboliet van terfenadien en is 'n nie-sederende, selektiewe histamien H -reseptor antagonis. 1
Feksofenadien toon 'n antihistaminiese effek binne een uur, en bereik 'n maksimum effek na 6 uur wat vir 24 uur lank duur.
FarmakokinetikaFeksofenadien word na orale toediening deur die liggaam geabsorbeer, met Tmaks
wat voorkom ongeveer 1 - 3 uur na dosering. Die gemiddelde C waarde was maks
omtrent 427 ng/ml en 494 ng/ml na die toediening van 'n 120 mg en 180 mg dosering een keer per dag, onderskeidelik. Die volume van distribusie is 5,4 – 5,8 ℓ/kg. Feksofenadien kruis nie die bloedbreinskans nie.
Feksofenadien is 60 - 70 % plasmaproteïengebonde. Feksofenadien ondergaan slegs geringe metabolisme (ongeveer 5 % van die totale dosis word gemetaboliseer, meestal deur die intestinale mukosa, terwyl slegs 0,5 – 1,5 % van die dosis hepatiese biotransformasie ondergaan), aangesien dit die enigste hoof samestelling is wat by diere en menslike feses en uriene geïdentifiseer was. Die plasmakonsentrasie profiele van feksofenadien volg 'n bi-eksponensiële afname met 'n terminale eliminasie halfleeftyd met 'n omvang van 11 - 15 uur, na veelvuldige dosering. Die enkel- en veelvuldige dosering farmakokinetika van feksofenadien is lineêr tussen 40 mg en 240 mg geneem per dag. Galuitskeiding (feses) blyk om die hoofroete van eliminasie te wees, terwyl tot 10 % van die dosis ingeneem onveranderd uitgeskei word deur die uriene.
Effek van ouderdomBy ouer persone (≥ 65 jaar oud), was die piek plasmavlakke van feksofenadien 99 % hoër as by dié wat waargeneem was by normale vrywilligers (< 65 jaar oud). Gemiddelde eliminasie halfleeftye was soortgelyk aan dié wat waargeneem was by normale vrywilligers.
Nierfunksie inkortingBy pasiënte met matige (kreatinienopruiming 41 – 80 ml/min) tot erge (kreatinienopruiming 11 – 40 ml/min) nierfunksie inkorting, was piek plasmavlakke van feksofenadien 87 % en 111 % hoër, respektiewelik, en die gemiddelde eliminasie halfleeftye was 59 % en 72 % langer, as dié waargeneem in normale vrywilligers. Piek plasmavlakke by pasiënte op dialise (kreatinienopruiming ≤ 10 ml/min) was 82 % groter en halfleeftyd was 31 % langer as dié waargeneem by normale vrywilligers.
INDIKASIES
FASTWAY 120 word aangedui vir die verligting van simptome geassosieer met seisoenale allergiese rinitis (SAR).
FASTWAY 180 word aangedui vir die verligting van simptome geassosieer met chroniese idiopatiese urtikarie (CIU).
KONTRA-INDIKASIESVeiligheid by swangerskap en laktasie is nog nie vasgestel nie (sien “WAARSKUWINGS”).
Die veiligheid en effektiwiteit van FASTWAY by kinders jonger as 12 jaar is nog nie bestudeer nie.
Pasiënte met 'n bekende hipersensitiwiteit vir FASTWAY of enige van die bestanddele.
WAARSKUWINGSDaar is slegs beperkte data vir die gebruik by bejaardes en by pasiënte met ingekorte nier- of lewerfunksie. FASTWAY moet versigtig gebruik word in hierdie spesiale risikogroepe.
FASTWAY is in borsmelk opgespoor.
FASTWAY kan die vermoë om te bestuur of masjinerie te hanteer beïnvloed.
INTERAKSIESInteraksie met ander medisynes en ander vorms van interaksie
FASTWAY ondergaan nie hepatiese biotransformasie nie. Daar was gevind dat gesamentlike toediening van FASTWAY en eritromisien of ketokonasool, kan lei tot 'n 2 – 3 voudige verhoging in die vlakke van FASTWAY in plasma. Hierdie veranderinge het nie gepaard gegaan met enige effekte op die QT-interval nie, en was nie geassosieer met enige toename van ongunstige effekte wanneer vergelyk word met wanneer die middels individueel toegedien is nie. Die verhoging in plasmavlakke van FASTWAY wat waargeneem is na gesamentlike toediening met eritromisien of ketokonasool, blyk te wees weens 'n toename in gastroїntestinale absorpsie, met óf 'n afname in galuitskeiding óf gastroïntestinale sekresie, respektiewelik.
Daar is geen interaksie tussen FASTWAY en omeprasool opgemerk nie. Die biobeskikbaarheid van FASTWAY word egter ingekort wanneer 'n teensuurmiddel wat aluminium en magnesiumhidrosied jel bevat, 15 minute voor FASTWAY toegedien word, waarskynlik as gevolg van verbinding in die spysverteringskanaal. Dit word voorgestel om 2 ure toe te laat tussen toediening van FASTWAY en teensuurmiddels wat aluminium en magnesiumhidroksied bevat.
SWANGERSKAP EN LAKTASIEDaar is geen ondervinding met FASTWAY by swanger vroue nie.
FASTWAY moet nie tydens swangerskap en laktasie geneem word nie.
DOSIS EN GEBRUIKSAANWYSINGSVolwassenes en kinders van 12 jaar en ouerChroniese idiopatiese urtikarie (CIU): Een 180 mg tablet per dag.
Seisoenale allergiese rinitis (SAR): Een 120 mg tablet per dag.
Kinders jonger as 12 jaar
Die veiligheid en effektiwiteit van FASTWAY by kinders jonger as 12 jaar is nog nie bestudeer nie.
Spesiale risikogroepe (sien “WAARSKUWINGS”)Gebasseer op die toenames in biobeskikbaarheid en halfleeftyd, word 'n dosis van 60 mg een keer per dag aanbeveel as die aanvangsdosis by pasiënte met nierinkorting.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS
Newe-effekte
Infeksies en infestasiesDikwels: Virale infeksies soos verkoue of griep
Senuweestelsel versteuringsDikwels: Hoofpyn, slaperigheid, duiseligheid Dikwels: MoegheidMinder dikwels: Slaaploosheid, senuweeagtigheid, slaapversteurings,
paranoia
Respiratories, torakaal en mediastinale versteuringsDikwels: Sinusitis
Gastroïntestinale versteuringsDikwels: Naarheid, dispepsie
Vel en onderhuidse weefsel versteuringsSeldsaam: Veluitslag, urtikarie, pruritis
Voortplanting en bors versteuringsDikwels: Dismenoree
AnderSeldsaam: Hipersensitiwiteitsreaksies met manifestasies soos
angio-edeem, bors- benoudheid, dispnee, blosing en sistemiese anafilakse
Spesiale VoorsorgmaatreëlsBy FASTWAY ontbreek sederende effekte. Pasiënte moet, nietemin, gewaarsku word dat 'n klein hoeveelheid individue wel sedasie mag ervaar. Dit word dus aanbeveel om individuele respons vas te stel voor die bestuur van 'n voertuig of uitvoer van ingewikkelde take. Hierdie effek kan vererger word deur die gelyktydige inname van alkohol of ander sentrale senuweestelsel onderdrukkers. (Sien “Farmakokinetika”, “INTERAKSIES” en “WAARSKUWINGS”).
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVANMeeste verslae oor FASTWAY oordosering bevat beperkte inligting. Duiseligheid, slaperigheid en droë mond is egter aangemeld. Standaard maatreëls moet oorweeg word om enige ongeabsorbeerde middel te verwyder. Hemodialise verwyder nie FASTWAY doeltreffend uit bloed nie.
IDENTIFIKASIEFASTWAY 120: Pienk gekleurde, ovaal-vormige, bikonvekse, filmbedekte tablette, geëmbosselleer met 'FXF' op een kant en '120' op die ander kant.
FASTWAY 180: Pienk gekleurde, ovaal-vormige, bikonvekse, filmbedekte tablette, geëmbosselleer met 'FXF' op een kant en '180' op die ander kant.
AANBIEDINGFASTWAY 120: Wit, ondeursigtige PVC/PE/PVDC stolpblaaie met 10 tablette, verpak in kartonne met 10 of 30 tablette.
FASTWAY 180: Wit, ondeursigtige PVC/PE/PVDC stolpblaaie met 10 tablette, verpak in kartonne met 10 of 30 tablette.
BERGINGSAANWYSIGINGSBerg by of benede 25 °C. Beskerm teen lig. Hou die stolpblaaie in die karton tot benodig word vir gebruik.
HOU BUITE DIE BEREIK VAN KINDERS.
REGISTRASIENOMMERSFASTWAY 120: 41/5.7.1/0319FASTWAY 180: 41/5.7.1/0320
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIESERTIFIKAAT VAN REGISTRASIEDr. Reddy's Laboratories (Edms) Beperk'The Place' SuidvleuelSandtonrylaan 1 Sandton 2196 Suid-Afrika
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
Augustus 2007
Fastway South Africa 150057170 Page 2 of 2
S2
250 - 150 mm
NOT TO BE PRINTEDVERSION : 2 (20-06-2014)Corrections done
NOT TO BE PRINTEDVERSION : 3 (09-07-2014)Corrections done
NOT TO BE PRINTEDVERSION : 4 (17-07-2014)Corrections done
Version No : 1 (Dt: 20-06-2014)
PANTONE CODES
Black C
40% of black C
Version No : 4
Dimensions : LxW (250-150 mm)Folded Size (150 x 40 mm)
