pharmaphorum

NOVEMBER 15, 2021

Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial. . billion in 2016 before the product was linked to an increased risk of lower limb amputation.

Diabetes 105

Diabetes Labelling 105

pharmaphorum

FEBRUARY 23, 2022

The drug was originally rejected for schizophrenia and bipolar by the FDA back in 2013 with a request for more clinical data, finally getting a green light two years later, and it then failed a phase 3 study in depression in 2016. Vraylar is now one of AbbVie’s fastest-growing products with sales expected to reach around $2.2

Labelling 52

Labelling 52

pharmaphorum

FEBRUARY 25, 2021

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

Documentation 111

Documentation Labelling 111

Pharmacy Joe

NOVEMBER 25, 2020

The trial that secured the approval of apixaban to treat VTE was published in 2013 in the New England Journal of Medicine. Dabigatran and edoxaban require 5 full days of parenteral anticoagulation therapy first, and apixaban and rivaroxaban have a period where a loading dose is given before dropping down to a lower maintenance dose.

Labelling 40

Labelling Hospitals Inpatient 40

RX Note

MARCH 28, 2023

Malaysia At Pharmacy Board 101th Meeting on 30th September 2013, minimum number of CPD points per year is set at 30 for renewal of Pharmacist Annual Retention. To illustrate, every now and then, I may encounter an off-label indication of medication that I do not know of. Nevertheless, I still miss my free lunch, and free pens much.

Hospitals 52

Hospitals Labelling Communication Pharmaceutical Companies 52

The Thyroid Pharmacist

AUGUST 23, 2023

Thiamine and fatigue in inflammatory bowel diseases: an open-label pilot study. 2013 Aug;19(8):704-8. Epub 2013 Feb 4. [8] Available from: [link] Accessed December 11, 2019 [7] Costantini A, Pala MI. J Altern Complement Med. doi: 10.1089/acm.2011.0840. 8] Comín-Anduix B, Boren J, Martinez S et al. 2001;268(15):4177-4182.

Dosage 98

Dosage Labelling 98

Pharmacy Friday Pearls

MARCH 9, 2022

vs 10.3% • p < 0.05, NNT = 5 Gerardo CJ, 2017 RCT in 18 ED in the US (n = 74) Crofab ® versus placebo to measure limb function 14 days after envenomation using Patient-Specific Functional Scale Crofab reduced limb disability measured by the Patient-Specific Functional Scale 14 days after copperhead envenomation. • in the treatment group vs 7.4

Immunity 40

Immunity Immunization Packaging Labelling 40

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C.

Compounding 52

Compounding Hospitals Labelling 52

RX Note

JUNE 4, 2023

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.

Drug Storage 52

Drug Storage Labelling Medication Labelling Documentation 52

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Labelling 45

Labelling Packaging Documentation 45

Eye on FDA

JUNE 14, 2023

But the numbers began to dwindle and 2013 was the last time the office even issued 12 letters within a year (it did 23 that year). The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation).

Labelling 82

Labelling Communication 82

The Thyroid Pharmacist

JULY 1, 2022

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. 2013 ; 51(5):293-296. Published 2013 Dec 6. It may be best to avoid eating out during this elimination period to avoid any cross-contamination that might skew your results. Acta Med Iran.

Compounding 52

Compounding Labelling Immunity Immunization 52

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. While maintaining probe contact on the skin, tilt it perpendicular to its long axis in each direction (also known as fanning) to assess the entire kidney (Video 1). Sibley et al.,

Labelling 177

Labelling Communication 177

RX Note

MARCH 31, 2023

KKLIU 0213/2013). Advertisements of Medicines to be Approved As stated in Section 4B , advertisements for the purpose of treatment or prevention of diseases other than specified in the Schedule has to been approved by the Medicine Advertisements Board. Advertisement approval number must be displayed on every advertisement.

Documentation 52

Documentation Labelling Diabetes Hospitals 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 55

Health and Personal Care Stores Labelling Immunity Immunization 55

The Thyroid Pharmacist

DECEMBER 28, 2022

Knowing there were others who also had thyroid conditions, and wanting to spread the message, I decided to summarize my research and improvements in my book, Hashimoto’s: The Root Cause, in 2013. When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it.

Immunity 110

Immunity Immunization Doctor of Pharmacy Clinical Pharmacology 110

European Pharmaceutical Review

OCTOBER 19, 2023

At MIP he brought six new radiopharmaceuticals to the clinic including the world’s first technetium-99m labeled PSMA inhibitor for imaging prostate cancer which is currently in a Phase III clinical trial. In 1998, John co-founded and was President and Chief Scientific Officer at Molecular Insight Pharmaceuticals (MIP) in Cambridge, US.

Chemotherapy 83

Chemotherapy Compounding Immunity Immunization 83

The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) I first reached out to Magdalena in 2013, after publishing my book Hashimoto’s: The Root Cause. She was a health coach specializing in hormones.

Compounding 52

Compounding Mayo Clinic Labelling Immunity 52

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” Published 2013 Apr 18. doi:10.1155/2013/767482. ScientificWorldJournal.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

pharmaphorum

AUGUST 5, 2020

Cell 2013; 153(6):1194–1217. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. Drug Discovery Today. López-Otín C, Blasco MA, Partridge L, Serrano M, Kroemer G. The hallmarks of aging. Justice JN, Nambiar AM, Tchkonia T, et al. EBioMedicine. 2019; 40:554–563.

Hospitals 80

Hospitals Labelling Diabetes Drug Development 80

The Thyroid Pharmacist

AUGUST 19, 2022

A 2013 Chinese study found a rate of H. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. Evidence-Based Complementary and Alternative Medicine 2013, Article ID 263805, 8 pages, 2013. pylori is treated. (2-7). percent of people with Hashimoto’s. (6)

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S. Int J Mol Sci.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

pharmaphorum

JANUARY 14, 2021

China has been the world’s second most valuable pharmaceutical market since 2013, but it has not been an important market in terms of contribution to the sales of the newer innovative pharmaceutical products – in fact, whilst China ranked second on total Rx market sales, it ranked below 30 in terms of sales of newly launched innovative products.

Biosimilars 71

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

The Thyroid Pharmacist

AUGUST 18, 2023

Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study. Published 2013 Dec 6. 2019;69:1-8. doi:10.1016/j.nutres.2019.05.001; 2019.05.001; Shep D, Khanwelkar C, Gade P, Karad S. 2019;20(1):214. Published 2019 Apr 11. Accessed 24 May, 2022. link] Miller AW, Dearing D.

Dosage 98

Dosage Compounding Labelling Diabetes 98

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Published 2013 Nov 15.

Dosage 121

Dosage Labelling Communication Compounding 121

The Thyroid Pharmacist

JULY 8, 2022

In one study done in 2013, patients with autoimmune thyroiditis were split into two groups, with one group being treated with 600 mg of myo-inositol and 83 mcg of selenium (selenomethionine) per day for 6 months, and the other being treated with just 83 mcg of selenium. doi:10.1155/2013/424163. doi:10.1155/2013/424163.

Dosage 59

Dosage Immunity Immunization Diabetes 59

The Thyroid Pharmacist

OCTOBER 27, 2023

Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage. Published 2013 Dec 26. 2013-3950. [30] Another resource for high-quality supplements is PureRXO.

Health and Personal Care Stores 66

Health and Personal Care Stores Immunity Immunization Compounding 66

The Thyroid Pharmacist

JULY 7, 2023

One study found that 92 percent of Hashimoto’s patients were deficient in vitamin D, and another 2013 study found that low vitamin D levels were associated with higher thyroid antibodies and worse disease prognosis. [61] The Journal of Clinical Endocrinology and Metabolism 2013:0021-972X. [60] 60] Schmeltz, Lowell R. Vojnosanit Pregl.

Immunity 104

Immunity Immunization Diabetes Dosage 104

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In doi:10.1155/2013/934183 [28] Siberian Ginseng. doi:10.1155/2013/514049; Cropley M, Banks AP, Boyle J. However, as with all substances, they can affect each individual differently.

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 90

The Thyroid Pharmacist

FEBRUARY 10, 2023

To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription. 2013 Oct;36(9):729-33; Eftekhar T, Sohrabvand F, Zabandan N, Shariat M, Haghollahi F, Ghahghaei-Nezamabadi A. Sex Med Rev. 2019;7(1):57-70. doi:10.1016/j.sxmr.2018.05.002 J Endocrine Invest.

Dosage 83

Dosage Documentation Diabetes Labelling 83