Notice in the State Food and Drug Administration on revision of the package insert of camp injection (2023 n. 49)

According to the evaluation results of adverse drug reactions, in order to further ensure the safety of drug use by the public, the State Food and Drug Administration has decided to make uniform amendments to the specifications for adenosine cyclophosphate injections (including cyclic AMP for injection, adenosine cyclophosphate injection, adenosine cyclophosphate glucose injection, and adenosine cyclochloride injection) . The relevant matters are hereby announced as follows: 

1. The holders of marketing licenses for the above-mentioned drugs shall, in accordance with the relevant provisions such as the measures for the administration of drug registration, and in accordance with the revised requirements of the specifications for cyclophosphamide injections (see annex) , the 2023 should be reported to the Provincial Drug Administration before July 20 for the record. Where the contents of the amendments involve drug labels, they shall be revised at the same time, and the instructions and other contents of the labels shall be in conformity with the original approved contents. Drugs manufactured on the date of filing shall not continue to use the original drug instructions. The holder of a drug marketing license shall, within 9 months after filing, replace the manufacturer's drug instructions and labels.

   2. Drug marketing licensees shall conduct in-depth studies on the mechanism of new adverse reactions, take effective measures to carry out publicity and training on the use and safety of drugs, and guide physicians and pharmacists in rational drug use.

   3. Clinicians and pharmacists should read the drug instructions carefully.

   4.Patients should read the drug instructions carefully before using drugs. Describe the revision of the drug package and conduct an adequate benefit/risk analysis based on the newly revised package insert when selecting a drug.

   5. The drug regulatory authorities at the provincial level shall urge the holders of drug marketing licenses for the above-mentioned drugs within the administrative areas to revise, label and replace the relevant specifications as required, we will severely investigate and punish illegal acts according to law. Notice is hereby given.

   
   

   Annex: revised requirements for the specifications of cyclic adenosine monophosphate injections

   
   

      Annex: REVISED SPECIFICATION FOR ADENOSINE INJECTION REVISED SPECIFICATION for adenosine injection (including cyclic AMP for injection, adenosine cyclophosphate injection, adenosine cyclophosphate glucose injection, and adenosine cyclophosphamide sodium chloride injection)

1. Adverse drug reactions should include, the following adverse events/events (incidence unknown) were detected after marketing: Systemic Reactions: Chills, chills, fever, and fatigue. Skin and subcutaneous tissue: erythema, papules, edema, wheal, flush, cyanosis, sweating, pruritus. Gastrointestinal system: dry mouth, vomiting, abdominal discomfort, abdominal distention, diarrhea. Nervous system: dizziness, head discomfort, hypoesthesia, dyskinesia, quadriplegia, loss of consciousness, convulsions, irritability. Cardiovascular system: palpitations, arrhythmias (such as tachycardia) , hypotension, hypertension. Respiratory system: chest tightness, chest pain, dyspnea, shortness of breath, throat edema, cough. Immune system: allergic reaction, anaphylaxis. Blood and lymphatic vessels: Phlebitis. Musculoskeletal and connective tissue: muscle weakness, limb pain. Second, [ taboo ] to this product any ingredient allergy is forbidden. NOTE: 1 cyclophosphamide injection may cause an allergic reaction. In severe cases, anaphylaxis may occur. Before taking the medicine, the patient should be asked about the allergic history, and if there is an adverse reaction after taking the medicine, the medicine should be stopped immediately and treated in time. 2 the speed should not be too fast in the first intravenous drip. (note: If the other contents of the specification are not in conformity with the above-mentioned revision requirements, they shall be revised together.)

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