Label indications. Medical search. Frequent questions

Featuring two tracks that come from Durand Jones & The Indications third LP, this 45 is a honeyed slice of retro-soul with pop leanings as the band continues to mine the 60's and 70's for inspiration. (hhv.de)
Durand Jones & the Indications aren't looking backwards. (shinybeast.nl)
Helmed by foil vocalists in Durand Jones and drummer Aaron Frazer, the Indications conjure the dynamism of Jackie Wilson, Curtis Mayfield, AND the Impressions. (shinybeast.nl)
The lead single from the sophomore LP from Durand Jones & The Indications has everything you could ask for. (shinybeast.nl)
Inspired by a handful of dusty and obscure 45's bearing names like The Ethics, Brothers of Soul and The Icemen, Durand Jones & The Indications set out to make their debut record steeped in heavy drums, blown-out vocals, and deep grooves. (shinybeast.nl)
Colemine releases a 7' featuring cuts from the debut album by Durand Jones & The Indications. (shinybeast.nl)
A quintet of revivalists who celebrated a style of soul that was popular decades before any of them were born, Durand Jones & The Indications met in the early 2010s while studying and playing music at Indiana University. (deezer.com)

Other device labeling that includes contraindications, warnings and precautions and/or promotional materials. (fda.gov)

If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling. (medscape.com)
There is limited information regarding Dextrose monohydrate injection (25%) FDA-Labeled Indications and Dosage (Pediatric) in the drug label. (wikidoc.org)

The Indications' 2016 self-titled debut was the product of friends who met as students at Indiana University in Bloomington, In. (shinybeast.nl)

There is limited information regarding Off-Label Non-Guideline-Supported Use of Cyanocobalamin in pediatric patients. (wikidoc.org)
There is limited information regarding FDA-Labeled Use of Aminoglutethimide in pediatric patients. (wikidoc.org)

There can be multiple indications to use a procedure or medication. (wikipedia.org)

NORTH CHICAGO, Ill. , Jan. 15, 2021 /PRNewswire/ -- Allergan Aesthetics and Allergan, Inc. , an AbbVie company (NYSE: ABBV), announced today that scientific and clinical experts in the field of neurotoxins will present results from 16 abstracts spanning pre-clinical and clinical studies evaluating key safety and efficacy of BOTOX® (onabotulinumtoxinA) across multiple therapeutic and cosmetic indications. (biospace.com)
However, by 6 March 2021, sponsors must replace any "free text" with permitted indications that are prescribed by the Therapeutic Goods (Permissible Indications) Determination (No.1) 2019 (Cth) ( PID ). (addisons.com)

Cite this: FDA Updates Indications for Temozolomide - Medscape - Sep 14, 2023. (medscape.com)

Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. (bvsalud.org)

The agency updated capecitabine's label in December 2022 to include eight new or revised indications, including adjuvant treatment of patients with stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen, and perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (medscape.com)
THOUSAND OAKS, Calif. , April 27, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced top-line results from two Repatha ® (evolocumab) open label extension (OLE) studies to the Phase 3 FOURIER cardiovascular outcomes trial. (amgen.com)

In this paper, we consider the changes relating to indications that are permitted for use in respect of complementary medicines listed on the Australian Register of Therapeutic Goods ( ARTG ). (addisons.com)
Further, indications must not refer to prohibited representations or restricted representations, as specified in Part 4 of the Therapeutic Goods Advertising Code ( Code ). (addisons.com)

Off label indications often have some clinical significance to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication. (wikipedia.org)
Therefore, the use of medications for indications beyond those formally evaluated is allowable in medical clinical practice. (elsevier.com)
Elsevier drug information includes off-label indications and other clinical data for drug therapy that may be outside the scope of the FDA-approved drug product labeling. (elsevier.com)

The US Food and Drug Administration (FDA) has updated the indications for temozolomide (Temodar) to include adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma. (medscape.com)

More on the DEAD OCEANS label. (shinybeast.nl)
They signed with Indiana record label Dead Oceans and began playing more shows throughout the world. (deezer.com)

With the Temperature Indication Label from Faller Packaging, you not only increase the ease of use , but also increase safety . (faller-packaging.com)
The labelling requirements cover packaging. (folkhalsomyndigheten.se)

The exclusive inclusion of only "labeled" information (e.g., uses for or information about a drug approved by the FDA and included within the FDA-approved product labeling) within our database would limit the utility and scope of our information to clinicians. (elsevier.com)

Labelling must comply with all relevant Australian requirements, as detailed in the document Requirements for OTC new medicine N2 applications , including all required warning statements. (tga.gov.au)
The TG Amendment Act establishes a 3 year transition period for sponsors of listed medicines to comply with changes made in respect of indications. (addisons.com)

A diagnosis is the assessment that a particular [medical] condition is present while an indication is a reason for use. (wikipedia.org)
Elsevier will rate all off-label indications using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.1-6 Each off-label use will be assigned a quality of evidence rating and a strength of recommendation by the Elsevier drug information editorial team. (elsevier.com)

In the United States, indications for prescription drugs are approved by the FDA. (wikipedia.org)
A 1996 GAO report (Prescription Drugs, Implications of Drug Labeling and Off-Label Use) has shown that "off-label" drug use (e.g., the use of a drug for an indication not approved by the FDA) is substantial in situations where satisfactory treatment is not available and that there are lower rates of off-label use when there is an effective therapy. (elsevier.com)

The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). (wikipedia.org)
The goal of the trial was to evaluate oral anticoagulation alone compared with oral anticoagulation plus clopidogrel among patients who underwent transcatheter aortic valve replacement (TAVR) and had a long-term indication for oral anticoagulation. (acc.org)
Patients who underwent TAVR and had a long-term indication for oral anticoagulation were randomized to oral anticoagulation alone (n = 164) versus oral anticoagulation plus clopidogrel for 3 months (n = 162). (acc.org)
Among patients who underwent TAVR and had an indication for long-term anticoagulation, oral anticoagulation alone was associated with a reduction in all bleeding and procedural bleeding compared with oral anticoagulation plus clopidogrel. (acc.org)
Data includes long-term immunogenicity rates across 10 therapeutic and aesthetic indications, analyses from the Adult Spasticity International Registry (ASPIRE) study and Cervical Dystonia Patient Registry for BOTOX® Efficacy (CD-PROBE), reviewing adherence to onabotulinumtoxinA treatment in patients with spasticity and efficacy and tolerability in patients with cervical dystonia, respectively. (biospace.com)
Aims: Our aim was to investigate one-year outcomes in patients treated with bioresorbable scaffolds (BRS) for "off-label" versus currently "established" indications. (elsevierpure.com)
Conclusions: In a real-world setting, the majority (88.9%) of patients were treated with BRS for off-label indications. (elsevierpure.com)
There is limited information regarding Off-Label Guideline-Supported Use of Cyanocobalamin in adult patients. (wikidoc.org)
The objective of PERTINENCE ( NCT04897763 ), an open-label, proof of concept study, is to evaluate safety profile, biodistribution and tumour targeting properties of TLX250-CDx given directly into the bladder in patients with NMIBC and to establish carbonic anhydrase IX (CAIX) as a potential therapeutic target in this condition. (aap.com.au)
The FOURIER-OLE (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated - Risk-Open Label Extension) studies were composed of study 20130295 (NCT02867813) with 5,035 patients enrolled in Eastern Europe and the United States and study 20160250 (NCT03080935) with 1,600 patients enrolled in Western Europe. (amgen.com)

Product labels were evaluated, information recorded, and afterwards data were complemented by consulting the scientific literature. (bvsalud.org)

Listed medicines may only comprise low level indications that are consistent with their "low risk" status. (addisons.com)
WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. (wikidoc.org)

In the United States there are label indications and off-label indications Label indications: Medication that have label indications mean that they were approved by the FDA. (wikipedia.org)
Drug companies can not provide any official medication information (e.g. package inserts) for off label indications. (wikipedia.org)
In our example label, an 'OK' is displayed so that the patient/user knows when the medication is ready for pain-free use. (faller-packaging.com)

The Australian Geographical Indication "Blackwood Valley" was entered in the Register of Protected Names on 10 December 1998 in response to a direction received by the Registrar from the Presiding Member of the Geographical Indications Committee acting under Section 40Z of the WAC Act 1980. (wineaustralia.com)

The Geographical Indication "Blackwood Valley" is located within the zone of South West Australia, within the State of Western Australia, Australia. (wineaustralia.com)
1) This Act regulates the legal protection of geographical indications used to designate goods and services of natural, agricultural, handicraft or industrial origin, except the geographical indications and designations of origin for agricultural products, foodstuffs and alcoholic beverages protected at Community level. (riigiteataja.ee)
2) The Ministry of Agriculture shall perform the national operations provided in Council Regulation (EU) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 208, 24.7.1992, pp. 1-8) and the operations prescribed with regard to the geographical indications and designations of origin of alcoholic beverages protected at Community level. (riigiteataja.ee)
The rights and obligations prescribed in legislation regulating the legal protection of geographical indications apply equally to natural and legal persons of the Republic of Estonia and of foreign states (hereinafter person ), considering restrictions provided for in this Act. (riigiteataja.ee)
The name of a geographical area serving as a geographical indication does not have to coincide with the current official name of that geographical area. (riigiteataja.ee)
1) A geographical indication may be in word form or in figurative form. (riigiteataja.ee)
2) A geographical indication in word form may be a word or phrase that is the name of a geographical area, includes it or refers to it. (riigiteataja.ee)
3) A geographical indication in figurative form may be a cartographic representation or symbol of a geographical area referring to a particular geographical area. (riigiteataja.ee)
1) Geographical indications shall be granted legal protection by registration in the state register of geographical indications (hereinafter register ) pursuant to the procedure provided for in this Act. (riigiteataja.ee)
2) Legal protection to geographical indications shall be ensured by exercising state supervision (hereinafter supervision ) and applying the enforcement powers of the state on the bases and pursuant to the procedure provided for in this Act. (riigiteataja.ee)
The extent of legal protection of a geographical indication shall be specified on the basis of the geographical indication registration (hereinafter registration ) data. (riigiteataja.ee)
Legal protection of geographical indications does not have a term. (riigiteataja.ee)

FOURIER-OLE (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated - Risk-Open Label Extension) were multicenter, open-label extension (OLE) studies designed to assess the extended long-term safety of evolocumab in subjects who completed the FOURIER study (20110118). (amgen.com)

Indications are included in the Indications and Usage section of the Prescribing Information. (wikipedia.org)
The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition. (wikipedia.org)
Additionally, the Indications and Usage section should contain the approved age groups as well as other information necessary to describe appropriate use (e.g., identifying the indicated patient/disease subgroups, stating if adjunctive therapy is required). (wikipedia.org)

American Love Call', the band's sophomore LP is instead the record the Indications dreamed of making, fleshed out with strings, backing vocals, and a newfound confidence in songwriting. (shinybeast.nl)

The Collective Label "TERROIR DU MAROC" is a tool for promoting local products on a national and international scale with a view to improving the income of the small producers concerned and increasing the quality of their products. (taybat.ma)
it also aims to give consumers and distributors confidence in these products by providing them with information on the quality of the products bearing this Label. (taybat.ma)

Even with an aesthetic steeped in the golden, strings-infused dreaminess of early '70s soul, the Indications' sophomore LP, 'American Love Call', is planted firmly in the present, with the urgency of this moment in time. (shinybeast.nl)

Importantly, there is a "fee free" period for sponsors to transition to using permitted indications in respect of their listed medicines. (addisons.com)
After this date, any changes made to indications in respect of listed medicines will incur a fee. (addisons.com)
3 The presentations are availab le at: http://www.who.int/selection_medicines/committees/expert/20/en/ (accessed 8 October 2015). (who.int)
The cancer medicines section of both Model Lists was updated to include specific indications for which each medicine was recommended. (who.int)

The labelling of foods is set out by Regulation (EC) No.1169/2011 and is enforced in Scotland by The Food Information (Scotland) Regulations 2014 (as amended). (highland.gov.uk)
The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling. (cms.gov)
These recommendations apply to all licensed influenza vaccines used within Food and Drug Administration (FDA)-licensed indications. (cdc.gov)

In order to represent such best practices in drug therapy, the Elsevier drug information editorial team follows a policy for content style and production, which includes a specific policy regarding off-label drug indication data. (elsevier.com)

Off-label use of BRS appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of this patient group. (elsevierpure.com)

Most countries and jurisdictions have a licensing body whose duty is to determine whether to approve a drug for a specific indication, based on the relative safety of the drug and its efficacy for the particular use. (wikipedia.org)

Importantly, a listed medicine cannot include any indication that refers to the prevention, cure or alleviation of any diseases, ailments, defects or injuries. (addisons.com)

Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive. (bvsalud.org)

Off-label data may be included in the monographs of FDA-approved drugs, investigational drugs, or dietary supplements. (elsevier.com)
Off-label drug indication data are included in our drug information database when identified as a clinically relevant or emerging treatment by the drug information editorial team. (elsevier.com)

When practitioners choose antibiotics, they aren't necessarily choosing them based on the labeled indication that the drug has. (contagionlive.com)

Essentially, if it is found that there is substantial evidence that benefits of treatment outweigh the risks, the proposed labeling in the Prescribing Information is appropriate, and the manufacturing process is safe and adequate, then the drug is approved to go to market under that now FDA-approved indication. (wikipedia.org)

3. Other device labeling. (fda.gov)
The shunt is not an implantable device and may only be used temporarily as described in the "Indications" above. (medtronic.com)

The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits. (wikipedia.org)
One approved indication for temozolomide remains the same: treatment of adults with newly diagnosed glioblastoma , alongside radiotherapy, and then as maintenance treatment. (medscape.com)

Early indications are that TLX250-CDx is showing promise as a diagnostic targeting agent in this disease, and we look forward to completing the study and presenting full results. (aap.com.au)
Neurochemical analysis provided an early indication of depressive behavior. (cdc.gov)

Indications can impact the pricing of medications through Value-based Pricing, also known as indication specific pricing or indication value-based pricing. (wikipedia.org)
An expected role of any drug compendia in regards to off-label drug use listings is to consolidate published scientific literature and to provide the user quick access to appropriate information that may assist in making a decision regarding the appropriate use of the drug for a specific patient. (elsevier.com)
Indications can be specific or non-specific in nature. (addisons.com)

Allergens require to be labelled and appropriately highlighted (i.e. underlined , bold text , italic text etc. (highland.gov.uk)
This supplement type does not usually require new labeling. (fda.gov)

Off-label: Off-label indications are drugs that are used for medical indications that have not been approved by the FDA. (wikipedia.org)
Since drugs can be used for different indications, this form of pricing would set different prices for each indication based on the value the drug offers for whatever it is being used to treat. (wikipedia.org)
The changes were made under the agency's Project Renewal program, an "initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date," the agency said today in a press release announcing the update. (medscape.com)

To support the user, we have equipped our example label with a sensor that turns blue and displays a snowflake when the medicine is stored below eight degrees Celsius and issues the message "OK" as soon as the medicine warms up above 18 degrees Celsius. (faller-packaging.com)
Indications are statements that describe the therapeutic use of a complementary medicine. (addisons.com)
These indications could be recorded as "free text" entries in the ARTG in respect of any listed complementary medicine. (addisons.com)
Following the commencement of the TG Amendment Act, any indication that is now used in respect of a listed medicine must be selected from the PID. (addisons.com)
Each sponsor must still hold evidence that substantiates the indication(s) relating to a complementary medicine listed on the ARTG. (addisons.com)

Based on these results, Telix's partner ATONCO intends to progress TLX250 labelled with the alpha-emitter astatine-211 ( 211 At) into a first-in-human Phase I targeted alpha therapy (TAT) study. (aap.com.au)

Differences between ACIP recommendations and labeled indications are noted in the Table . (cdc.gov)

and Ontario Agency for Health label indication. (cdc.gov)

Put podofilox gel on as you have been told by the doctor or on the package labeling. (drugs.com)

There is limited information regarding Cyanocobalamin Postmarketing Experience in the drug label. (wikidoc.org)

See 17 for PATIENT COUNSELING INFORMATION and FDA‑approved patient labeling (Patient Information). (drugs.com)

Having a copy of Hitler's speeches on your nightstand is an indication that you need to use the Jewish Space Laser and probably should never have been put in a position of power and influence. (mcsweeneys.net)

If only you had read the label instead of futzing around all day, you could have avoided this and would be more like your cousin Reuven who already finished medical school. (mcsweeneys.net)

Temozolomide is the second drug to receive a labeling update under the pilot program, following capecitabine (Xeloda). (medscape.com)

The FOURIER-OLE is composed of studies 20130295 and 20160250, which enrolled 5,035 and 1,600 subjects who completed FOURIER study (20110118) to receive open-label evolocumab and were followed up for a median of 5 and 4.6 years, respectively. (amgen.com)

may apply for new indications to be added to the PID. (addisons.com)
It is open to sponsors or others to apply for new indications to be included in future editions of the PID on the basis that they meet the relevant criteria and are approved by the TGA. (addisons.com)

Anatomy11

Organisms4

Diseases21

Chemicals and Drugs58

Analytical, Diagnostic and Therapeutic Techniques and Equipment101

Psychiatry and Psychology1

Phenomena and Processes25

Disciplines and Occupations10

Anthropology, Education, Sociology and Social Phenomena3

Technology, Industry, Agriculture7

Humanities1

Information Science12

Named Groups1

Health Care45

Geographicals6

Durand Jones7

Contraindications1

Dosage2

20161

Pediatric2

Multiple indications1

20212

20231

20191

20222

Therapeutic Goods2

Clinical3

Adjuvant1

Dead Oceans2

Packaging2

Inclusion1

Comply2

Assessment2

Prescription drugs2

Patients10

Product1

Consistent2

Medication3

Committee1

Geographical12

Cardiovascular1

Usage3

Band's1

Products2

American Love Call1

Medicines4

Food3

Includes1

Outcomes1

Efficacy1

Include1

Rapidly1

Data2

Antibiotics1

Substantial1

Device2

Treatment2

Early2

Specific3

Require2

Drugs3

Medicine5

Results1

Recommendations1

Health1

Package1

Drug label1

Patient1

Space1

Read1

Program1

Years1

Apply2