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Medical Network July 28 News On July 27, the State Food and Drug Administration issued an announcement on the revision of the instructions for vitamin B6 injections (No.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
Appendix:
Revision of the instruction manual ofvitamin B6 injection
1.
[Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post- marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, redness, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Neuropsychiatric system: dizziness, headache, paresthesia, irritability, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, increased or decreased blood pressure, etc.
;
;
Respiratory system: shortness of breath, difficulty breathing, etc.
;
;
Medication site: pain at the injection site, itching at the injection site, rash at the injection site, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Immune system: allergic-like reactions, anaphylactic shock, etc.
;
;
Other: flushing, pallor, cold extremities
.
.
2.
[Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
Amendments to the Instructions for Vitamin B6 for Injection
1.
[Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post-marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Nervous system: dizziness, headache, paresthesia, etc.
;
;
Respiratory system: difficulty breathing, shortness of breath, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, etc.
;
;
Medication site: pain at the injection site, etc.
;
;
Immune system: allergic reactions, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Other: pale, flushing and so on
.
.
2.
[Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
Medical Network July 28 News On July 27, the State Food and Drug Administration issued an announcement on the revision of the instructions for vitamin B6 injections (No.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
Appendix:
Revision of the instruction manual of vitamin B6 injection
1.
[Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post- marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, redness, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Neuropsychiatric system: dizziness, headache, paresthesia, irritability, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, increased or decreased blood pressure, etc.
;
;
Respiratory system: shortness of breath, difficulty breathing, etc.
;
;
Medication site: pain at the injection site, itching at the injection site, rash at the injection site, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Immune system: allergic-like reactions, anaphylactic shock, etc.
;
;
Other: flushing, pallor, cold extremities
.
.
2.
[Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
Amendments to the Instructions for Vitamin B6 for Injection
1.
[Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post-marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Nervous system: dizziness, headache, paresthesia, etc.
;
;
Respiratory system: difficulty breathing, shortness of breath, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, etc.
;
;
Medication site: pain at the injection site, etc.
;
;
Immune system: allergic reactions, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Other: pale, flushing and so on
.
.
2.
[Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
Medical Network July 28 News On July 27, the State Food and Drug Administration issued an announcement on the revision of the instructions for vitamin B6 injections (No.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
97 of 2021).
Based on the results of adverse drug reaction evaluations, the National Drug Administration has further ensured the safety of drug use by the public.
The Administration decided to make unified revisions to the [Adverse Reactions] and [Contraindications] items of the Vitamin B6 injection instructions
.
Appendix:
Appendix:Revision of the instruction manual of vitamin B6 injection
Revision of the instruction manual of vitamin B6 injection 1.
[Adverse Reaction] item should be added:
1. [Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post- marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Drug side effects Drug Drug adverse side effects Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, redness, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Neuropsychiatric system: dizziness, headache, paresthesia, irritability, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, increased or decreased blood pressure, etc.
;
;
Respiratory system: shortness of breath, difficulty breathing, etc.
;
;
Medication site: pain at the injection site, itching at the injection site, rash at the injection site, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Immune system: allergic-like reactions, anaphylactic shock, etc.
;
;
Other: flushing, pallor, cold extremities
.
.
2.
[Taboo] item should be added:
2. [Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
Amendments to the Instructions for Vitamin B6 for Injection
Amendments to the Instructions for Vitamin B6 for Injection 1.
[Adverse Reaction] item should be added:
1. [Adverse Reaction] item should be added:
[Adverse Reaction] item should be added:
Post-marketing adverse drug reaction monitoring found that this product has the following adverse reactions/event reports:
Systemic reactions: chills, chills, fever, fatigue, etc.
;
;
Skin and its accessories: rash, itching, sweating, etc.
;
;
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort, etc.
;
;
Nervous system: dizziness, headache, paresthesia, etc.
;
;
Respiratory system: difficulty breathing, shortness of breath, etc.
;
;
Cardiovascular system: chest tightness, palpitations, cyanosis, etc.
;
;
Medication site: pain at the injection site, etc.
;
;
Immune system: allergic reactions, etc.
;
;
Musculoskeletal: limb pain, etc.
;
;
Other: pale, flushing and so on
.
.
2.
[Taboo] item should be added:
2. [Taboo] item should be added:
[Taboo] item should be added:
People who are allergic to this product and its ingredients are prohibited
.
.
(Note: In principle, the manual cannot be deleted.
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
If the safety content of the original approved manual is more comprehensive or stricter than the revised recommendations, the original approved content should be retained
.
If the other content of the manual is inconsistent with the above-mentioned revised requirements, it should be included.
Make revisions
.
)
