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health canada advisories & notices<br />

June 10, 2009<br />

June 5, 2009<br />

June 4, 2009<br />

June 4, 2009<br />

June 4, 2009<br />

May 25, 2009<br />

May 25, 2009<br />

May 25, 2009<br />

May 19, 2009<br />

May 19, 2009<br />

May 19, 2009<br />

May 19, 2009<br />

May 4, 2009<br />

May 4, 2009<br />

Health Canada is advis<strong>in</strong>g Canadians to carefully read <strong>the</strong> label<strong>in</strong>g of iron supplement products as <strong>the</strong>re is potential<br />

for confusion about dosage. Products currently on <strong>the</strong> Canadian market display <strong>the</strong> dose <strong>in</strong> different ways on <strong>the</strong><br />

product label and consumers may mis<strong>in</strong>terpret <strong>the</strong> amount of iron <strong>in</strong> <strong>the</strong> product and potentially take an <strong>in</strong>correct<br />

dose.<br />

Important Safety Information concern<strong>in</strong>g Kappa 600/700/900 Series and Sigma 100/200/300 Series Implantable<br />

Pulse Generators – Medtronic of Canada Ltd. advises health care professionals to consider device replacement <strong>in</strong><br />

pacemaker dependent patients and to cont<strong>in</strong>ue rout<strong>in</strong>e follow up for pacemaker <strong>in</strong>dependent patients.<br />

Cases of pure red cell aplasia (PRCA) have been reported <strong>in</strong> patients treated with CellCept (mycophenolate mofetil)<br />

<strong>in</strong> comb<strong>in</strong>ation with o<strong>the</strong>r immunosuppressive agents.<br />

Health Canada is warn<strong>in</strong>g consumers not to use <strong>the</strong> unauthorized product Slim Magic Herbal, which is promoted<br />

as a weight-loss product, as it was found to conta<strong>in</strong> an undeclared pharmaceutical <strong>in</strong>gredient similar to <strong>the</strong><br />

prescription drug sibutram<strong>in</strong>e. Canadians who have this Slim Magic Herbal product are advised to immediately<br />

discont<strong>in</strong>ue its use.<br />

Health Canada is advis<strong>in</strong>g consumers not to use 6 foreign health products due to concerns about possible sideeffects.<br />

The products are Fangocur M<strong>in</strong>eral Dr<strong>in</strong>k, Jia Yi Jian, Fortodol (which is also sold under <strong>the</strong> names<br />

Donsbach Mirad<strong>in</strong>, Lepicol Mirad<strong>in</strong>, Lepp<strong>in</strong> Mirad<strong>in</strong>, and Mirad<strong>in</strong>); Shan Dian Qiang Xiao Shou, - Zencore Plus and<br />

Zhong Guo Shen Fang<br />

Maxum Multi-Vite has been approved as a vitam<strong>in</strong>-m<strong>in</strong>eral supplement for only <strong>the</strong> general public but lacks <strong>the</strong><br />

required cautionary statement on <strong>the</strong> label regard<strong>in</strong>g pregnant and/or breast feed<strong>in</strong>g women. The product Maxum<br />

Matragen is be<strong>in</strong>g promoted by <strong>the</strong> company as a prenatal supplement; however, nei<strong>the</strong>r product has been<br />

authorized for sale by Health Canada for use by women who are pregnant or breastfeed<strong>in</strong>g.<br />

Novopharm Limited is recall<strong>in</strong>g 1 lot of Dobutam<strong>in</strong>e <strong>in</strong>jection 250mg/20ml due to an error on <strong>the</strong> labels. The dos<strong>in</strong>g<br />

<strong>in</strong>structions on <strong>the</strong>se vials are labeled 2.5 to 10 mg/kg/m<strong>in</strong> <strong>in</strong>stead of 2.5 to 10 µg/kg/m<strong>in</strong>. The lot be<strong>in</strong>g recalled is:<br />

Lot 1156283 (expiry date: March 31, 2010).<br />

One lot of Rofact (rifamp<strong>in</strong>) DIN 00343617, manufactured by Valeant Canada, is be<strong>in</strong>g recalled to <strong>the</strong> retail level.<br />

Some bottles of <strong>the</strong> lot 8K5467 may conta<strong>in</strong> <strong>the</strong> drug clonazepam <strong>in</strong>stead of <strong>the</strong> antibiotic rifamp<strong>in</strong>.<br />

Health Canada is warn<strong>in</strong>g consumers that <strong>the</strong>re is a small possibility that some bottles of one lot of Rofact®<br />

(rifamp<strong>in</strong>), an antibiotic used to treat tuberculosis (TB) and some o<strong>the</strong>r <strong>in</strong>fections, may conta<strong>in</strong> <strong>the</strong> drug clonazepam<br />

<strong>in</strong>stead of <strong>the</strong> antibiotic rifamp<strong>in</strong>.<br />

BHM Medical Inc. advises Canadian healthcare professionals to visually <strong>in</strong>spect <strong>the</strong> sl<strong>in</strong>gs prior to use and discard<br />

<strong>the</strong> products if <strong>the</strong>re is thread breakage at <strong>the</strong> junction of <strong>the</strong> shoulder strap and sl<strong>in</strong>g body.<br />

Fatal adverse reactions have occurred <strong>in</strong> patients with moderate hepatic impairment and advanced solid tumours<br />

treated with TARCEVA (erlot<strong>in</strong>ib).<br />

MedXL Inc. advises Canadian healthcare professionals to visually <strong>in</strong>spect <strong>the</strong> prefilled sal<strong>in</strong>e and hepar<strong>in</strong> syr<strong>in</strong>ges<br />

prior to use and not to use <strong>the</strong> products if <strong>the</strong> solution is discolored or conta<strong>in</strong>s a precipitate.<br />

Health Canada is aware of <strong>the</strong> public warn<strong>in</strong>g issued by <strong>the</strong> U.S. Food and Drug Adm<strong>in</strong>istration (FDA) Warn<strong>in</strong>g on<br />

May 1, 2009 regard<strong>in</strong>g certa<strong>in</strong> Hydroxycut products. The FDA is advis<strong>in</strong>g U.S. consumers to stop us<strong>in</strong>g Hydroxycut<br />

products as <strong>the</strong>re have been reports of liver <strong>in</strong>juries potentially associated with this product <strong>in</strong> <strong>the</strong> United States.<br />

Health Canada is advis<strong>in</strong>g Canadians not to purchase products claim<strong>in</strong>g to fight or prevent H1N1 flu virus (human<br />

sw<strong>in</strong>e flu). While <strong>the</strong>re are approved antiviral drugs that may help prevent or reduce <strong>the</strong> symptoms associated with<br />

<strong>the</strong> flu <strong>in</strong> general, <strong>the</strong>re are currently no products authorized for sale <strong>in</strong> Canada that are <strong>in</strong>dicated specifically for<br />

<strong>the</strong> treatment of H1N1 flu virus (human sw<strong>in</strong>e flu).<br />

For complete <strong>in</strong>formation & electronic mail<strong>in</strong>g of <strong>the</strong> Health Canada Advisories/Warn<strong>in</strong>gs/Notices subscribe onl<strong>in</strong>e at:<br />

http://www.hc-sc.gc.ca/dhp-mps/medeff/<strong>in</strong>dex_e.html<br />

MedEffect e-Notice is <strong>the</strong> new name which replaces Health Canada’s Health_Prod_Info mail<strong>in</strong>g list.<br />

The content of <strong>the</strong> e-notices you receive will rema<strong>in</strong> <strong>the</strong> same and are now part of MedEffect, a new Health Canada Web site dedicated to<br />

adverse reaction <strong>in</strong>formation. MedEffect can be visited at www.hc-sc.gc.ca/dhp-mps/medeff/<strong>in</strong>dex_e.html<br />

Health Canada Notices are also l<strong>in</strong>ked under “Notices” on <strong>the</strong> OCP website: www.ocp<strong>in</strong>fo.com<br />

pharmacyconnection • July/August 2009<br />

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