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Revised: 18 July 2017

What's New

Additions to the Medsafe Website from 10-17 July 2017


COMMITTEES
Medicines Adverse Reactions Committee
Medicines Adverse Reactions Committee - Minutes for the 170th meeting - 8 June 2017

SAFETY
Alert Communication
UPDATE - Heater-cooler devices used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations

Consumer Level Recall – NovoPen® Echo®

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Varilrix Vaccine varicella vaccine injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Capecitabine capecitabine tablet
Updated
Tradename Active ingredient(s) Dose form
Apidra and Apidra SoloStar neutral insulin injection
Arrow - Diazepam diazepam tablet
Arrow - Morphine morphine tablet
Arrow - Tramadol tramadol capsule
Benzac AC gel benzoyl peroxide topical gel
Benzac AC Wash benzoyl peroxide topical solution
Bimatoprost Actavis bimatoprost eye drops
Citalopram (PSM Healthcare Ltd trading as API Consumer Brands) citalopram tablet
Clexane and Clexane Forte enoxaparin sodium injection
Cotellic cobimetinib tablet
Daktarin miconazole oral gel
DBL Magnesium Chloride magnesium chloride injection
DBL Metronidazole metronidazole infusion
DBL Phenytoin phenytoin injection
DBL Zoledronic Acid zoledronic acid infusion
Entonox nitrous oxide; oxygen gas
HyperHep B hepatitis b immunoglobulin (human) injection
Imbruvica ibrutinib capsule
Lantus and Lantus SoloStar neutral insulin injection
Neo-B12 hydroxocobalamin injection
Nitrous Oxide nitrous oxide; oxygen gas
Oxycodone Orion oxycodone injection
Rifadin rifampicin capsule
tablet
oral suspension
injection
Stesolid Rectal Tubes diazepam enema
Topiramate Actavis topiramate tablet
Varilrix Vaccine varicella vaccine injection


Additions to the Medsafe Website from 4 – 7 July 2017


COMMITTEES

Medicines Classification Committee
Recent New Zealand Gazette Notices Relating to Classification

MEDICINES
Reminder
Change to the Label Statement Database for Esomeprazole (refer to item 8.2.1a of the Medicines Classification Committee meeting minutes

Change to the Label Statement Database for topical miconazole (refer to the outcome of consultation)

SAFETY
Alert Communication
Use of Tramadol During Breastfeeding

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Ibrance palbocicib capsule
Updated
Tradename Active ingredient(s) Dose form
Amoxil amoxicillin sodium injection
Flucloxacillin (AFT) flucloxacillin capsule
oral solution
Flucloxin flucloxacillin injection
Ibiamox amoxicillin injection
Keytruda pembrolizumab infusion
Orion Temozolomide temozolomide capsule
Reandron 1000 testosterone injection
Telfast Oral Liquid fexofenadine suspension
Tramadol tramadol capsule
Uptravi selexipag tablet
Valtrex valaciclovir tablet
Zyban bupropion tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Ibrance palbocicib capsule
Nucala mepolizumab injection
Orion Temozolomide temozolomide capsule
Zithromax azithromycin dehydrate infusion
Updated
Tradename Active ingredient(s) Dose form
Adalat Oras nifedipine tablet
Alfentanil alfentanil injection
Amoxiclav Multichem amoxicillin; clavulanic acid injection
Buscopan hyoscine injection
Cefazolin-AFT cefazolin injection
Dalacin C clindamycin capsule
Dalacin C Phosphate clindamycin injection
DBL Pemetrexed (as disodium) lixisenatide infusion
Exemestane Pfizer exemestane tablet
Flucloxacillin (AFT) flucloxacillin capsule
oral solution
Flucloxin flucloxacillin injection
Glamin alanine; arginine; aspartic acid; glutamic acid; glycyl-l-glutamine; glycyl-l-tyrosine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valine infusion
Glycoprep-C macrogols; potassium chloride; sodium chloride; sodium sulfate powder
Ibiamox amoxicillin injection
Ibrance palbocicib capsule
Kabiven G11% amino acid solution with electrolytes, glucose solution and lipid emulsion injection
Kabiven G19% amino acid solution with electrolytes, glucose solution and lipid emulsion injection
Keppra levetiracetam tablet
Keytruda pembrolizumab infusion
LMX4 lidocaine cream
Lyxumia lixisenatide injection
Methadone BP (AFT Pharmaceuticals) methadone injection
Metvix methyl aminolevulinate cream
Midazolam-Claris midazolam injection
Minirin desmopressin injection
Morphine Juno morphine injection
Octostim desmopressin injection
Ondansetron-DRLA ondansetron tablet
Panadol paracetamol tablet
Panadol Extra with Optisorb paracetamol tablet
Panadol Optisorb paracetamol caplet
Picoprep citric acid; magnesium oxide; sodium picosulfate powder for solution
Prepkit-C citric acid; macrogols; magnesium oxide; potassium chloride; sodium chloride; sodium picosulfate; sodium sulfate combination
Reandron 1000 testosterone injection
Remifentanil-AFT remifentanil injection
Rifinah isoniazid; rifampicin tablet
Sporanox itraconazole capsule
Sporanox itraconazole oral solution
Telfast Oral Liquid fexofenadine suspension
Tobrex tobramycin ointment
Tramadol (AFT) tramadol capsule
Uptravi selexipag tablet
Yervoy ipilimumab injection
Zithromax azithromycin dehydrate oral suspension
tablet
Zyban bupropion tablet


Additions to the Medsafe Website from 26 June – 3 July 2017


COMMITTEES

Medicines Classification Committee
Minutes of the 58th meeting of the Medicines Classification Committee - 16 May 2017
Dates and Deadlines have been updated

MEDICINES
Policy Statements
Change to Label Statement Database for OTC loratadine and desloratadine medicines

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Cilazapril cilazapril tablet
Apo-Cilazapril/Hydrochlorothiazide cilazapril; hydrochlorothiazide tablet
Apo-Diltiazem CD diltiazem capsule
Apo-Leflunomide leflunomide tablet
Updated
Tradename Active ingredient(s) Dose form
Abraxane paclitaxel injection
Condyline podophyllotoxin topical solution
Ibuprofen (Generic Partners) ibuprofen capsule
Locoid hydrocortisone topical ointment
topical emulsion
topical cream
scalp lotion
Nitrados nitrazepam tablet
Pimafucort hydrocortisone; natamycin; neomycin topical ointment
topical cream
Premarin conjugated estrogens tablet
Trichozole metronidazole tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Abraxane paclitaxel injection
Condyline podophyllotoxin topical solution
Eprex erythropoietin injection
Fentanyl (AstraZenca) fentanyl injection
Forxiga dapagliflozin tablet
Gastrolyte Electrolyte Hydration citric acid; glucose; potassium chloride; sodium bicarbonate; sodium chloride
effervescent tablet
Gastrolyte Electrolyte Hydration glucose; potassium chloride; sodium acid citrate; sodium chloride powder for oral solution
Granisetron (DEVA) granisetron injection
Imatis imatinib tablet
Locoid hydrocortisone topical ointment
topical emulsion
topical cream
scalp lotion
Methotrexate Sandoz methotrexate injection
Nitrados nitrazepam tablet
Pimafucort hydrocortisone; natamycin; neomycin topical ointment
topical cream
Q300 quinine tablet
Ramipex pramipexole tablet
Stelara ustekinumab injection
Trichozole metronidazole tablet
Vallergan Forte alimemazine syrup


Additions to the Medsafe Website from 19-23 June 2017

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Dopress dosulepin tablet
Entocort budesonide capsule
Fortum ceftazidime injection
Ox-Pam oxazepam tablet
Q300 quinine tablet
TMP trimethoprim tablet
Ventavis iloprost inhalation
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Apo-Diltiazem diltiazem capsule
Ceftriaxone (Devatis Limited) ceftriaxone injection
infusion
Dopress dosulepin tablet
Edurant rilpivirine tablet
Entocort budesonide capsule
Fortum ceftazidime injection
Frisium clobazam tablet
Lemtrada alemtuzumab infusion
Marcain Spinal bupivacaine injection
Marcain Spinal (Heavy) bupivacaine; glucose injection
Mersyndol codeine; doxylamine; paracetamol tablet
caplet
Methotrexate Sandoz methotrexate injection
Ox-Pam oxazepam tablet
Rythmodan disopyramide capsule
Serenace haloperidol tablet
Sirturo bedaquiline tablet
TMP trimethoprim tablet
Ventolin salbutamol inhaler
Ventolin Nebules salbutamol solution for inhalation
 

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