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 |
