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You can double click on a word to look it up on TermGallery.
You can double click on a word to look it up on TermGallery.
Meanings of package insert in English
Material affixed to a container or article with printed information.
Related terms
Document accompanying a medication.
Synonyms
Examples for "spc"
Examples for "spc"
1
Disability organisations in region hope SPC can further help in their work
2
SPC is a regional organisation that helps the development of 22 countries.
3
SPC is a regional organization that helps the development of 22 countries.
4
The SPC in the past has typically gone along with ADNOC's recommendations.
5
The SPC was formed in 1974 to oversee the country's oil interests.
1
A patient information leaflet or eye swab had no effect on the main outcomes.
2
A full list of the possible side effects can be found in the patient information leaflet, available here.
3
Written patient information leaflets have not been surpassed by other communication methods.
4
Method: A structured review of patient information leaflets about hayfever.
5
GPs rarely perform eye swabs or give patient information leaflets to patients with AIC.
1
Patients will be randomized to either intravenous ferric carboxymaltose (dose based according to Summary of Product Characteristics) or intravenous placebo.
1
The present study evaluated which monitoring instructions are given in the SmPCs, and assessed whether instructions are informative enough to be applicable in clinical practice.
Usage of package insert in English
1
Amgen said the side effects are already included in the drug's package insert label.
2
The same dangers were previously printed in bold-face type in Enbrel's package insert label.
3
The same dangers have previously been printed in bold-face type in Enbrel's package insert label.
4
Every prescription drug comes with what is called a drug information insert or package insert.
5
Spectrum said the FDA did not request any changes to the currently approved indications and package insert.
6
Background and Purpose- The 2015 updated US Food and Drug Administration alteplase package insert altered several contraindications.
7
For new drugs, the information listed on the package insert comes primarily from FDA-required studies on the drug.
8
The package insert for IFX recommends that maintenance therapy be prescribed for patients who respond to induction therapy.
9
According to the package insert, Anadrol (oxymetholone) is an anabolic steroid, a synthetic derivative of testosterone.
10
Conclusion: This study found that testicular doses from Zevalin were much lower than that originally reported in the package insert.
11
Mylotarg's package insert label in the United States says the drug was approved based on its ability to shrink tumors.
12
An indication on the drug package insert that no negative effects have been found does not mean there aren't any.
13
Tysabri's package insert label cautions that patients taking the drug have a 1-in-1,000 risk of developing PML.
14
It said safety risks are noted in the product's package insert label and that cardiac monitoring is suggested in patients with cardiac risk factors.
15
Genzyme, based in Cambridge, Massachusetts, said data from the four-year North American study was recently added to the package insert label of the drug.
16
The drugs' makers have also added risk of heart attack, stroke, or sudden death in people with undiagnosed heart problems to their package inserts.