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Revised: 16 July 2019

About Medsafe

What's New

Additions to the Medsafe Website from 28 June - 7 July 2019


Publications
Consumer Information Leaflet
Taking Lithium during pregnancy (PDF 319 KB, 2 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Loxamine paroxetine tablet
Montelukast Mylan montelukast tablet
Oxycodone Sandoz oxycodone tablet
Repatha evolocumab injection
Updated
Tradename Active ingredient(s) Dose form
3% Citanest Dental with Octapressin felypressin; prilocaine solution for injection
Aclasta zoledronic acid infusion
Actair dermatophagoides farinae allergen extract; dermatophagoides pteronyssinus allergen extract tablet
Atripla efavirenz; emtricitabine; tenofovir tablet
Azamun azathioprine tablet
Bydureon exenatide injection
Celazadine azacitidine injection
Clustran sumatriptan injection
Darzalex daratumumab concentrate for infusion
Doxine doxycycline film coated tablet
Dynacirc SRO isradipine capsule
Eltroxin levothyroxine tablet
Enlafax XR venlafaxine modified release capsule
Eviplera emtricitabine; rilpivirine; tenofovir tablet
Exelon rivastigmine capsule, oral solution
Exelon Patch rivastigmine patch
Forxiga dapagliflozin tablet
Ganfort bimatoprost; timolol eye drops
Ganfort PF bimatoprost; timolol eye drops
HBvaxPRO hepatitis b vaccine injection
Keytruda pembrolizumab powder for infusion; concentrate for infusion
Lithicarb FC lithium film coated tablet
Logem lamotrigine chewable/dispersible tablet
Lopresor metoprolol tablet, injection
Maviret glecaprevir; pibrentasvir tablet
Mekinist trametinib tablet
Methoblastin methotrexate tablet
Naglazyme galsulfase injection
Neoral ciclosporin capsule, oral solution
Oralair grass pollen extract tablet
Otezla apremilast film coated tablet
Paxam clonazepam tablet
Plendil ER felodipine tablet
Pomalyst pomalidomide capsule
Primolut N norethisterone tablet
Puregon follitropin injection
Revlimid lenalidomide capsule
Sandimmun ciclosporin infusion
Simulect basiliximab injection
Stamaril yellow fever vaccine suspension for injection
Symmetrel amantadine capsule
Tafinlar dabrafenib capsule
Tobradex dexamethasone; tobramycin eye drops
Tobrex tobramycin eye drops, ointment
Trichozole metronidazole tablet
Trisul sulfamethoxazole; trimethoprim tablet
Truvada emtricitabine; tenofovir tablet
Venclexta venetoclax tablet
Vfend voriconazole film coated tablet; powder for injection; powder for oral suspension
Vidaza azacitidine injection
Vttack voriconazole tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Aspen Ciprofloxacin ciprofloxacin injection
Benztropine Omega benzatropine injection
Cefuroxime (Devatis) cefuroxime injection
Loxamine paroxetine tablet
Mekinist trametinib tablet
Methylphenidate Extended Release (Teva) methylphenidate tablet
Montelukast Mylan montelukast tablet
Naloxone Juno naloxone injection
Oxaliplatin oxaliplatin infusion
Repatha evolocumab injection
Rivastigmine Patch rivastigmine patch
Tafinlar dabrafenib capsule
Urchol ursodeoxycholic acid capsule
Valganciclovir (Max Health) valganciclovir tablet
Updated
Tradename Active ingredient(s) Dose form
3% Citanest Dental with Octapressin felypressin; prilocaine solution for injection
Accupril quinapril tablet
Aclasta zoledronic acid infusion
Actrapid neutral insulin injection
Albey wasp and bee venom protein injection
Alimta pemetrexed infusion
Alphagan brimonidine eye drops
Alphagan P brimonidine eye drops
Apo-Clomipramine clomipramine tablet
Aricept donepezil tablet
Arrow - Amitriptyline amitriptyline tablet
Arrow - Morphine LA morphine tablet
Aspen Adrenaline adrenaline injection
Atripla efavirenz; emtricitabine; tenofovir tablet
Atropt Eye Drops atropine eye drops
Avastin bevacizumab infusion
Azamun azathioprine tablet
Bydureon exenatide injection
Canesoral fluconazole capsule
Canesoral Duo clotrimazole; fluconazole combination
Carafate sucralfate tablet
Chlorsig chloramphenicol eye ointment
Cilicaine procaine penicillin solution for injection
Climara estradiol patch
Colgout colchicine tablet
Combigan brimonidine; timolol eye drops
Copaxone glatiramer injection
Cytotec misoprostol tablet
Darzalex daratumumab concentrate for infusion
DBL Flucloxacillin Sodium flucloxacillin sodium injection
Deolate terbinafine tablet
Diflucan fluconazole capsule, powder for oral suspension, solution for injection
Dostinex cabergoline tablet
Doxine doxycycline film coated tablet
Dozile doxylamine capsule
Duolin Inhaler ipratropium; salbutamol aerosol inhaler, metered dose
Dynacirc SRO isradipine capsule
Effient prasugrel tablet
Enlafax XR venlafaxine modified release capsule
Etopophos etoposide powder for injection
Eviplera emtricitabine; rilpivirine; tenofovir tablet
Exelon rivastigmine capsule, oral solution
Exelon Patch rivastigmine patch
Forxiga dapagliflozin tablet
Fungilin amphotericin b lozenge
Ganfort bimatoprost; timolol eye drops
Ganfort PF bimatoprost; timolol eye drops
HBvaxPRO hepatitis b vaccine injection
Henry Schein Lidocaine HCl 2% and Epinephrine lidocaine, epinephrine injection
Humulin neutral insulin injection
Keytruda pembrolizumab powder for infusion; concentrate for infusion
Klean-Prep macrogols; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate oral solution
Leukeran chlorambucil tablet
Lithicarb FC lithium film coated tablet
Locacorten-Viaform clioquinol; flumetasone ear drops
Logem lamotrigine tablet
Loniten minoxidil tablet
Lopresor metoprolol solution for injection
MabThera rituximab infusion
Maviret glecaprevir; pibrentasvir tablet
Maxigesic ibuprofen; paracetamol film coated tablet
Midazolam midazolam injection
Minidiab glipizide tablet
Minomycin minocycline tablet
Mivacron mivacurium injection
Mixtard 30 neutral insulin injection
Mycamine micafungin powder for injection
Mycobutin rifabutin capsule
Naglazyme galsulfase injection
Neoral ciclosporin capsule, oral solution
Nilstat nystatin tablet, capsule, oral drops, vaginal cream
Noradrenaline BNM noradrenaline injection
Normacol Plus rhamnus frangula, sterculia oral solution
Omegaven egg lecithin; fish oil; glycerol emulsion for infusion
Ovestin estriol vaginal cream
Ovestin estriol tablet
Ovestin estriol pessary
Oxaliplatin Accord oxaliplatin infusion
Oxycodone Sandoz oxycodone tablet
Paxam clonazepam tablet
Penmix neutral insulin injection
Pexsig perhexiline tablet
Piramal Sevoflurane sevoflurane volatile liquid for inhalation
Precedex dexmedetomidine infusion
Pregabalin Pfizer pregabalin capsule
Primolut N norethisterone tablet
Protamine Sulphate protamine sulfate solution for injection
Protaphane neutral insulin injection
Provera medroxyprogesterone tablet
Puregon follitropin injection
Puri-nethol mercaptopurine tablet
RiaSTAP (powder only) fibrinogen injection
Rocuronium Bromide (Hameln) rocuronium injection
Salazopyrin sulfasalazine tablet
Sandimmun ciclosporin infusion
Septanest adrenaline; articaine solution for injection
Sevredol morphine tablet
Silvasta sildenafil tablet
Simdax levosimendan infusion
Simulect basiliximab injection
Symmetrel amantadine capsule
Tacrolimus Sandoz tacrolimus capsule
Tobradex dexamethasone; tobramycin suspension, ointment
Tobrex tobramycin eye drops and ointment
Tracrium atracurium injection
Trandate labetalol solution for injection
Tranexamic Acid Link tranexamic acid injection
Trichozole metronidazole tablet
Trisul sulfamethoxazole; trimethoprim tablet
Truvada emtricitabine; tenofovir tablet
Venclexta venetoclax tablet
Vimizim elosulfase alfa injection
Vitalipid N Adult dl-alpha tocopherol; ergocalciferol; phytomenadione; retinol emulsion for injection
Vitalipid N Infant dl-alpha tocopherol; ergocalciferol; phytomenadione; retinol emulsion for injection
Volulyte hydroxyethyl starch, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, sodium (na+ ), potassium (k+ ), magnesium (mg2+), chloride (cl- ), acetate (ch3coo- ) infusion
Voluven poly-o-(2-hydroxyethyl)-starch; sodium chloride infusion
Vttack voriconazole tablet
Xylocaine Viscous lidocaine oral solution
Zyrtec cetirizine oral solution, tablet

 

Additions to the Medsafe Website from 25 May to 27 June 2019


Committees

Medicines Adverse Reactions Committee
Agenda for the 178th Medicines Adverse Reactions Committee meeting - 13 June 2019

Medicines Classification Committee
Reclassification of melatonin
Minutes of the 62nd meeting of the Medicines Classification Committee - 11 April 2019

Consumers
Patient Information Leaflets
Fire hazard from skin products containing paraffin (PDF 301 KB, 1 page)

Consultations
Current
Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Outcome
Outcome of consultation on the revision of CMN Form B

Medicines
Forms
Changed Medicine Notification Form B (effective from July 2019) (Microsoft Word 160KB)

Publications
Prescriber Update - June 2019

Safety
Alert
Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson)

Dear Healthcare Professional Letters
Xiaflex (collagenase clostridium histolyticum) product discontinuation from 28 June 2019 (PDF 231 KB, 2 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Aratac amiodarone tablet
Curam amoxicillin; clavulanic acid oral suspension
Updated
Tradename Dose form Active ingredient(s)
Cetrotide cetrorelix injection
Giotrif afatinib tablet
Maviret glecaprevir; pibrentasvir tablet
Metopirone metyrapone capsule
Tasigna nilotinib capsule
Triumeq abacavir; dolutegravir; lamivudine tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Aczone dapsone topical gel
Aratac amiodarone tablet
Neutrafluor 5000 plus sodium fluoride toothpaste
Nicorette nicotine invisipatch
Updated
Tradename Active ingredient(s) Dose form
Abraxane paclitaxel injection
Arrow - Bendrofluazide bendroflumethiazide tablet
Arrow - Dortim dorzolamide; timolol eye drops
Arrow - Etidronate etidroic acid tablet
Arrow - Fluoxetine fluoxetine capsule, tablet
Arrow - Lamotrigine lamotrigine tablet
Arrow - Losartan hydrochlorothiazide; losartan tablet
Burinex bumetanide tablet
Cetrotide cetrorelix injection
Condyline podophyllotoxin topical solution
Curam amoxicillin; clavulanic acid oral suspension
Daivobet 50/500 betamethasone; calcipotriol topical ointment
Daivobet 50/500 betamethasone; calcipotriol topical gel
DBL Irinotecan irinotecan injection
Droleptan droperidol injection
Flixonase Allergy & Hayfever 24 Hour fluticasone nasal spray
Fucithalmic fusidic acid eye drops
Giotrif afatinib tablet
Glytrin glyceryl trinitrate sublingual spray
Ibavyr ribavirin tablet
Jespect japanese encephalitis vaccine injection
Linezolid Kabi linezolid infusion
Maviret glecaprevir; pibrentasvir tablet
Methatabs methadone tablet
Metopirone metyrapone capsule
Mitozantrone Ebewe mitoxantrone injection
Omeprazole Actavis omeprazole capsule
Paroxetine paroxetine tablet
Questran Lite colestyramine oral suspension
Tasigna nilotinib capsule
Tecentriq atezolizumab infusion
Tranexamic Acid tranexamic acid tablet
Tranexamic-AFT tranexamic acid injection
Viaderm KC gramicidin; neomycin; nystatin; triamcinolone cream, ointment

 

Additions to the Medsafe Website from 16-24 May 2019


CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Jinarc tolvaptan combination, tablet
Navelbine vinorelbine capsule
Navelbine vinorelbine injection
Travatan travoprost eye drops
Updated
Tradename Active ingredient(s) Dose form
3TC lamivudine oral solution, tablet
Accuretic hydrochlorothiazide; quinapril tablet
Oraqix lidocaine; prilocaine periodontal gel
Sotalol sotalol tablet
Typhim Vi typhoid vaccine injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Jinarc tolvaptan combination, tablet
Linezolid Juno linezolid tablet
Linezolid Juno linezolid infusion
Linezolid (Neo Health) linezolid tablet
Linezolid (Neo Health) linezolid infusion
Travatan travoprost eye drops
Updated
Tradename Active ingredient(s) Dose form
3TC lamivudine oral solution
Accuretic hydrochlorothiazide; quinapril tablet
Amirol amitriptyline tablet
Biodone methadone oral solution
Carbosorb charcoal, activated oral suspension
Emtriva emtricitabine capsule
Epiduo adapalene; benzoyl peroxide gel
Glycophos sodium glycerophosphate infusion
Kabiven G11% alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, soya oil, glucose monohydrate, calcium chloride dihydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, sodium glycerophosphate injection
Kabiven G19% alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, soya oil, glucose monohydrate, calcium chloride dihydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, sodium glycerophosphate injection
Mifegyne mifepristone tablet
Mirvaso brimonidine topical gel
Movicol Junior macrogols; potassium chloride; sodium bicarbonate; sodium chloride oral solution
Movicol Lemon-Lime Flavour macrogols; potassium chloride; sodium bicarbonate; sodium chloride oral solution
Navelbine vinorelbine injection
Navelbine vinorelbine capsule
Oraqix lidocaine; prilocaine periodontal gel
Ringers calcium chloride; potassium chloride; sodium chloride infusion
Ropivacaine-AFT ropivacaine injection
Sotalol sotalol tablet
Vimpat lacosamide tablet, injection
 

Additions to the Medsafe Website from 7-16 May 2019


SAFETY

Monitoring Communication
Risk of infections with Prolia (denosumab)

Dear Healthcare Professional Letter
Actemra – New important identified risk: Hepatoxicity (PDF 361 KB, 3 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Accarb acarbose tablet
Updated
Tradename Active ingredient(s) Dose form
Bisolvon Chesty Forte bromhexine tablet
Bricanyl terbutaline turbuhaler
Dilantin phenytoin capsule, tablet, oral suspension
Efexor-XR venlafaxine capsule
Hepsera adefovir tablet
Lamictal lamotrigine tablet
Lorstat atorvastatin tablet
Nyxoid naloxone nasal spray
Opdivo nivolumab infusion
Oraqix lidocaine; prilocaine periodontal gel
Sprycel dasatinib tablet
Venclexta venetoclax tablet
Yervoy ipilimumab injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Accarb acarbose tablet
Aramine metaraminol injection
Devatis benzydamine; chlorhexidine oral spray
Devatis benzydamine; chlorhexidine gargle
Iloprost (Clinect) iloprost infusion
Metaraminol Phebra 10mg/mL metaraminol injection
Metaraminol Phebra 0.5mg/10mL metaraminol injection
Nicorette nicotine oral spray
Updated
Tradename Active ingredient(s) Dose form
Adenuric febuxostat tablet
Adriamycin doxorubicin injection
Aubagio teriflunomide tablet
Bexsero meningococcal vaccine injection
Bisolvon Chesty Forte bromhexine tablet, oral solution
Bricanyl terbutaline turbuhaler
Cerezyme imiglucerase infusion
Colestid colestipol oral suspension
Colpocin-T metronidazole infusion
Glaumox acetazolamide injection
Havrix hepatitis a vaccine injection
Havrix Junior hepatitis a vaccine injection
Hepsera adefovir tablet
Hizentra normal immunoglobulin injection
Imuran azathioprine injection
Imuran azathioprine tablet
Kemadrin procyclidine tablet
Kombiglyze XR metformin; saxagliptin tablet
Lanoxin digoxin tablet
Lanoxin Paediatric digoxin elixir
Lanoxin PG digoxin tablet
Lorstat atorvastatin tablet
Magnevist gadopentetic acid injection
Mitomycin mitomycin injection
Norflex orphenadrine tablet
Opdivo nivolumab infusion
Parnate tranylcypromine tablet
Pharmorubicin epirubicin injection
Prostin VR Pediatric alprostadil injection
SmofKabiven alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, soya oil, fish oil - rich in omega-3 acids, medium chain triglycerides, olive oil, glucose monohydrate, calcium chloride dehydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, sodium glycerophosphate, zinc sulfate heptahydrate emulsion for infusion
SmofKabiven Electrolyte Free alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, soya oil, fish oil - rich in omega-3 acids, medium chain triglycerides, olive oil, glucose monohydrate emulsion for infusion
SMOFlipid fish oil; medium-chain triglycerides; olive oil; soya oil infusion
Soluvit N ascorbic acid; biotin; cyanocobalamin; folic acid; nicotinamide; pantothenic acid; pyridoxine; riboflavin; thiamine injection
Span-K potassium chloride tablet
Spiolto Respimat olodaterol; tiotropium solution for inhalation
Spiriva Respimat tiotropium solution for inhalation
Tubersol tuberculin purified protein derivative injection
Ursofalk ursodeoxycholic acid capsule
Venclexta venetoclax tablet
Viread tenofovir tablet
Yervoy ipilimumab injection

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