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Medical Network News on June 22, the State Food and Drug Administration issued an announcement stating that according to the results of the adverse drug reaction assessment, it was decided to make unified revisions to the instructions of carbimazole tablets [adverse reactions] [taboos] [precautions] and other items
.
.
The announcement stated that the [ adverse reactions ] item of carbimazole tablets should contain 8 items, involving blood and lymphatic system, hepatobiliary system, skin and its accessories, gastrointestinal system, endocrine system, musculoskeletal system, nervous system and others
.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
At the same time, the announcement requires that the item of carbimazole tablets [medicine for the elderly] should be revised to "in elderly patients, although drug accumulation is not expected, it is still recommended to carefully adjust the dose under close monitoring and individual adjustment"
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
In addition, the announcement also stipulates the content that should be included in the item of carbimazole tablets [medication for pregnant and lactating women] [drug interactions]
.
.
The announcement pointed out that the holders of the drug marketing authorization of carbimazole tablets should revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration " and report to the provincial drug regulatory authority for record before September 8, 2021; the amendments involve The drug label shall be revised together; the instructions and other contents of the label shall be consistent with the original approved contents
.
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
.
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
Medical Network News on June 22, the State Food and Drug Administration issued an announcement stating that according to the results of the adverse drug reaction assessment, it was decided to make unified revisions to the instructions of carbimazole tablets [adverse reactions] [taboos] [precautions] and other items
.
.
The announcement stated that the [ adverse reactions ] item of carbimazole tablets should contain 8 items, involving blood and lymphatic system, hepatobiliary system, skin and its accessories, gastrointestinal system, endocrine system, musculoskeletal system, nervous system and others
.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
At the same time, the announcement requires that the item of carbimazole tablets [medicine for the elderly] should be revised to "in elderly patients, although drug accumulation is not expected, it is still recommended to carefully adjust the dose under close monitoring and individual adjustment"
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
In addition, the announcement also stipulates the content that should be included in the item of carbimazole tablets [medication for pregnant and lactating women] [drug interactions]
.
.
The announcement pointed out that the holders of the drug marketing authorization of carbimazole tablets should revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration " and report to the provincial drug regulatory authority for record before September 8, 2021; the amendments involve The drug label shall be revised together; the instructions and other contents of the label shall be consistent with the original approved contents
.
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
.
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
Medical Network News on June 22, the State Food and Drug Administration issued an announcement stating that according to the results of the adverse drug reaction assessment, it was decided to make unified revisions to the instructions of carbimazole tablets [adverse reactions] [taboos] [precautions] and other items
.
.
The announcement stated that the [ adverse reactions ] item of carbimazole tablets should contain 8 items, involving blood and lymphatic system, hepatobiliary system, skin and its accessories, gastrointestinal system, endocrine system, musculoskeletal system, nervous system and others
.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
Adverse reactions adverse reactions adverse reactions accessories accessories accessories Women Women Women.
[Contraindications] The item should contain 5 items, such as "For those who are allergic to carbimazole, methimazole, other thiourea derivatives or any excipients of this product ", "moderate to severe blood cell count disorder (neutropenia) ) Are forbidden" and so on
.
[Note] entry should contain 9 content, such as "Pregnant women, abnormal liver function, neutropenia should be careful.
" "During treatment, reproductive age women need to use effective contraceptive measures"
.
At the same time, the announcement requires that the item of carbimazole tablets [medicine for the elderly] should be revised to "in elderly patients, although drug accumulation is not expected, it is still recommended to carefully adjust the dose under close monitoring and individual adjustment"
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
.
[Drug overdose] item should be revised as "Drug overdose can cause hypothyroidism and the corresponding symptoms of reduced metabolism.
Through feedback effects, the pituitary gland can be activated, and then the growth of goiter can occur
.
Once the metabolic state of normal thyroid function is reached, it will be about dose reduction, you can avoid this from happening, if necessary, can be added levothyroxine
.
negative consequences of accidental ingestion of high doses of carbimazole cause is unknown "
.
In addition, the announcement also stipulates the content that should be included in the item of carbimazole tablets [medication for pregnant and lactating women] [drug interactions]
.
.
The announcement pointed out that the holders of the drug marketing authorization of carbimazole tablets should revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration " and report to the provincial drug regulatory authority for record before September 8, 2021; the amendments involve The drug label shall be revised together; the instructions and other contents of the label shall be consistent with the original approved contents
.
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
Drugs Drugs Drugs Drug Registration Drug Registration Drug Registration .
Drugs produced from the date of filing the revised leaflet shall not continue to use the original drug leaflet; the holder of the drug marketing authorization shall replace the drug leaflet and label that has been released from the factory within 9 months after the filing
.
The provincial drug regulatory department shall urge the holders of the marketing authorization of carbimazole tablets in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law
.
(National News)
