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Revised: 21 September 2017

What's New

Additions to the Medsafe Website from 11-18 September 2017

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Zydelig Idelalisib tablet
Updated
Tradename Active ingredient(s) Dose form
2% Xylocaine Dental with Adrenaline Adrenaline; Lidocaine injection
Apidra and Apidra Solostar Neutral insulin injection
Entapone Entacapone tablet
Imovane Zopiclone tablet
Intelence Etravirine tablet
Lantus and Lantus SoloStar Neutral insulin injection
Marvelon 28 Desogestrel; ethinylestradiol tablet
Sabril Vigabatrin tablet
Tecentriq Atezolizumab infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Flumazenil-Claris Flumazenil injection
Zydelig Idelalisib tablet
Updated
Tradename Active ingredient(s) Dose form
2% Xylocaine Dental with Adrenaline Adrenaline; Lidocaine injection
4% Articadent Dental with Adrenaline Adrenaline; Articaine injection
Apidra and Apidra Solostar Neutral insulin injection
Cardizem Diltiazem tablet
Cardizem CD Diltiazem capsule
Cefazolin-AFT Cefazolin injection
Cyklokapron Tranexamic acid tablet
injection
DBL Aciclovir Intravenous Aciclovir infusion
DBL Carboplatin Carboplatin injection
DBL Cisplatin Cisplatin injection
DBL Dacarbazine Dacarbazine injection
DBL Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate injection
DBL Ephedrine Sulfate Ephedrine Sulfate injection
Depo-Medrol with Lidocaine Methylprednisolone acetate; lidocaine hydrochloride injection
Entapone Entacapone tablet
Haldol Haloperidol decanoate injection
Leveitracetam-AFT Leveitracetam oral solution
infusion
Levemir Insulin detemir injection
Locacorten-Viaform Clioquinol; Flumetasone ear drops
Locorten-Vioform Clioquinol; Flumetasone ear drops
Medrol Methylprednisolone acetate tablet
Nivestim Filgrastim injection
Oralair (Initiation and Continuation treatment) Initiation (Allergens; Grass pollen extract)
Continuation (Grass pollen extract)
tablet
Panadeine Extra Codeine; Paracetamol tablet
Panafen Plus Codeine; Ibuprofen tablet
Sabril Vigabatrin tablet
Tecentriq Atezolizumab infusion
Tranexamic-AFT Tranexamic acid injection
Xigduo XR Dapagliflozin; Metformin tablet
Zerbaxa Ceftolozane; Tazobactam injection


Additions to the Medsafe Website from 28 August-8 September 2017


PUBLICATIONS
Prescriber Update 38(3) September 2017

SAFETY INFORMATION
The Surgical Mesh Implants information has been updated

VACANCIES
Advisor Pharmacovigilance (Fixed Term)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
4% Articadent Dental with Adrenaline adrenaline; articaine injection
Updated
Tradename Active ingredient(s) Dose form
Aclin sulindac tablet
Apo-Mirtazapine mirtazapine tablet
Betoptic betaxolol eye drops
Biltricide praziquantel tablet
Brolene propamidine eye drops solution
Catapres clonidine injection
Cetrotide cetrorelix injection
Concerta ER methylphenidate tablet
Diamide loperamide capsule
Diamide Relief loperamide capsule
Exjade deferasirox tablet
Imigran sumatriptan tablet
Mozobil plerixafor injection
Neulactil periciazine tablet
Neulactil periciazine tablet
Nevirapine Alphapharm nevirapine tablet
Noflam naproxen tablet
Noxafil posaconazole tablet
oral suspension
Omezol IV omeprazole infusion
Pradaxa dabigatran capsule
Praxbind idarucizumab injection
Prezista darunavir tablet
Proctosedyl cinchocaine; hydrocortisone suppository
Proctosedyl cinchocaine; hydrocortisone ointment
Synacthen Depot tetracosactide injection
Synflorix pneumococcal vaccine injection
Ultiva remefentinal injection
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir combination product
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir combination product
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Alendronate Plus D3 alendronic acid; colecalciferol tablet
Glucose 5% Freeflex (Fresenius Kabi) glucose infusion
Jaqinus tofacitinib tablet
Updated
Tradename Active ingredient(s) Dose form
Aclin sulindac tablet
Apo-Cilazapril cilazapril tablet
Apo-Diclo EC diclofenac tablet
Apo-Diclo SR diclofenac tablet
Apomine apomorphine injection
Avastin bevacizumab infusion
Azactam aztreonam injection
Biltricide praziquantel tablet
Biltricide praziquantel tablet
Cetrotide cetrorelix injection
Codalgin codeine phosphate; paracetamol tablet
Concerta ER methylphenidate tablet
Daonil glibenclamide tablet
DBL Aminophylline aminophylline injection
DBL Diazoxide diazoxide injection
DBL Epirubicin Hydrochloride epirubicin hydrochloride injection
DBL Ergometrine ergometrine injection
DBL Hyoscine hyoscine injection
DBL Irinotecan irinotecan injection
DBL Magnesium Sulfate magnesium sulfate injection
DBL Zine Chloride zine chloride injection
Diamide loperamide capsule
Diamide Relief loperamide capsule
Exjade deferasirox tablet
Ibucode Plus codeine; ibuprofen tablet
Ibuprofen (Teva) ibuprofen tablet
Imigran sumatriptan tablet
Jaqinus tofacitinib tablet
Jetrea ocriplasmin injection
Kadcyla trastuzumab emtansine infusion
Mozobil plerixafor injection
Nevirapine Alphapharm nevirapine tablet
Noflam naproxen tablet
NovoRapid and NovoMix 30 neutral insulin injection
Noxafil posaconazole tablet
oral suspension
Noxafil posaconazole injection
Omezol IV omeprazole infusion
Opdivo nivolumab infusion
Oxaliccord oxaliplatin infusion
Plaquenil hydroxychloroquine tablet
Plavix clopidogrel tablet
Pradaxa dabigatran capsule
Praxbind idarucizumab injection
Proctosedyl cinchocaine; hydrocortisone suppository
Proctosedyl cinchocaine; hydrocortisone ointment
Rapamune sirolimus oral solution
tablet
Ricit finasteride tablet
Rixubis nonacog gamma injection
Stemetil prochlorperazine injection
Ultiva remefentinal injection
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir combination product
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir combination product


Additions to the Medsafe Website from 21-25 August 2017


COMMITTEES

Medicines Adverse Reactions Committee
Agenda for the 171st meeting - 14 September 2017

SAFETY
Alert Communications
Gadolinium based contrast agents for MRI and retention of gadolinium in the brain

Monitoring Communications
Watch out for INR changes when direct-acting antivirals (DAAs) are used concomitantly with warfarin

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Betoptic S betaxolol eye drops suspension
Brufen ibuprofen tablet
Brufen SR ibuprofen modified release tablet
Cyclogyl cyclopentolate eye drops solution
Intelence etravirine tablet
Keytruda pembrolizumab infusion
Mydriacyl tropicamide eye drops solution
Patanol olopatadine eye drops solution
Rythmodan disopyramide capsule
Travatan travoprost eye drops solution
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
DBL Midazolam midazolam injection
Updated
Tradename Active ingredient(s) Dose form
Arimidex anastrozole tablet
Brufen ibuprofen tablet
Brufen SR ibuprofen modified release tablet
Cefazolin-AFT cefazolin injection
Diflucan fluconazole capsule
oral suspension
injection
Flucil flucloxacillin injection
Gastrolyte citric acid; glucose; potassium chloride; sodium bicarbonate; sodium chloride tablet
oral solution
Intelence etravirine tablet
Iressa gefitinib tablet
Keytruda pembrolizumab infusion
Neurontin gabapentin capsule
tablet
Synthamin 17 (without and with electrolytes) alanine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine (without electrolytes)
alanine; arginine; dibasic potassium phosphate; glycine; histidine; isoleucine; leucine; lysine; magnesium chloride; methionine; phenylalanine; proline; serine; sodium acetate; sodium chloride; threonine; tryptophan; tyrosine; valine (with electrolytes)
infusion
Tramadol Hydrochloride tramadol capsule
Trinomia aspirin; atorvastatin; ramipril capsule
Truvada tenofovir disoproxil fumarate; emtricitabine tablet
Vepacel influenza vaccine monovalent injection
Viread tenofovir disoproxil fumarate tablet


Additions to the Medsafe Website from 14-18 August 2017


COMMITTEES
Medicines Adverse Reactions Committee
Vacancy

Medicines Classification Committee
Agenda for the 59th meeting
Dates and Deadlines

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Bosentan Mylan bosentan tablet
Minirin desmopressin nasal drops
Rifadin (IV) rifampicin injection
Rifadin (Oral) rifampicin capsule
tablet
oral suspension
Rytmonorm propafenone tablet
Solian amisulpride tablet
oral solution
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Atropine Sulphate atropine injection
Travatan Z travoprost eye drops
Updated
Tradename Active ingredient(s) Dose form
Aerrane isoflurane liquid for inhalation
Bosentan Mylan bosentan tablet
Brolene propamidine (drops);
dibrompropamidine (ointment)
eye drops solution
eye drops ointment
Ceftriaxone (DEVA) ceftriaxone injection
infusion
DBL Calcium Gluconate calcium gluconate injection
Granisetron (Deva) granisetron injection
Hydrea hydroxycarbamide capsule
Imatinib-AFT imatinib capsule
Lantus and Lantus SoloStar neutral insulin injection
Minirin desmopressin nasal drops
Neulactil periciazine tablet
Norspan buprenorphine patch
Oruvail SR ketoprofen capsule
OxyContin oxycodone tablet
OxyNorm oxycodone injection
OxyNorm oxycodone capsule
oral solution
Ramipex pramipexole tablet
Reyataz atazanavir capsule
Rytmonorm propafenone tablet
Suprane desflurane liquid for inhalation
Syntometrine ergometrine; oxytocin injection
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