Administration revised lai ammonia aspirin for injection instruction: after children’s drugs or cause reye syndrome

recently, the state food and drug supervision bureau released on revising with lai ammonia injection aspirin manual announcement no. 11 (2018).

administration on revising with lai ammonia injection aspirin instructions announcement no. 11 (2018)

according to the results of the adverse drug reactions assessment in order to further ensure public security, the state food and drug supervision and administration bureau decided to lai ammonia aspirin instruction for injection increase warnings, and 【 indications 】 【 side effect 】 【 notes 】 children’s drugs and so on a revised 】. Will now matters related to notice the following:

a, all with lai ammonia injection aspirin production enterprise shall be in accordance with the relevant provisions of the “drug registration management measures” and so on, in accordance with the requirements for injection by lai wood manual revision (see attachment), put forward to revise the description of the supplement, on March 31, 2018 at the provincial food and drug regulatory authorities for the record.

revised content involves drug label, should be revised; Specification and other contents label shall be consistent with the original approval content. Within 6 months after the supplement for the record to all have factory instructions and labels to be replaced.

each vial lai ammonia wood production enterprise shall on new adverse reaction mechanism to carry out in-depth study, to take effective measures to make use and safety propaganda and training, to guide rational drug use.

2, clinicians should be read carefully for injection lai ammonia Lin manual revision content, horse, when choosing drugs shall be amended according to the new instruction to fully benefit/risk analysis.

3, patients should strictly prescribed medication, should read the instructions carefully before using this drug.

vial lai ammonia aspirin manual revision request

a, warnings

add warnings: & other; This product can lead to adverse reactions such as anaphylactic shock, serious skin damage. Medicine should be closely monitored in the process, if a skin rash, itching, breathing problems, asthma, laryngeal edema, blood pressure to drop, such as signs or symptoms, should be stopped immediately and timely treatment. Throughout the &;

2, indications

by & other; Used for heat and light, moderate pain & throughout; Modified to & other; Does not apply to oral dosing of fever and the treatment of moderate pain & throughout; .

three, adverse reactions to

【 side effect 】 in & other; Allergy & throughout; And & other Reye syndrome & throughout; Revised as the following:

an allergic reaction: a few patients after using a skin rash, hives, asthma, allergic reactions such as angioneurotic oedema or mucosal hyperemia, serious anaphylactic shock can occur. Asthma which is more, and more in over 30 middle-aged, difficulty breathing, breathing in for several minutes, called & other; Aspirin asthma & throughout; That can be life-threatening. Have reported serious skin damage include: bulla sex skin rashes, toxic epidermal necrosis release and exfoliative dermatitis, etc.

reye syndrome: use this product to children under the age of 16 May be reye syndrome. 1 & ndash; 2 weeks with chickenpox or flu-like symptoms in children and teenagers should not use this product. As the crowd suddenly appeared severe headache after using this product, such as frequent vomiting and irritability performance, should be alert to reye syndrome. This kind of situation, although rare, the nervous system symptoms progress rapidly, can be life-threatening.

4, note

【 notes 】 to increase the following content:

the drug can cause anaphylactic shock. Doctors should ask patients with history of drug allergy medication to closely monitor in the process, if a skin rash, itching, breathing problems, laryngeal edema, blood pressure to drop, such as signs and symptoms, should be stopped immediately and timely treatment.

the drug can cause serious skin damage, including bulla sex skin rashes, toxic epidermal necrosis release, exfoliative dermatitis, etc. If the patient after drug adverse reactions such as a skin rash, itching, should immediately stop medicine and clinic in time.

five, children’s drugs

“medicine for children” is amended as:

children under the age of 16 with caution, infant banned under 3 months. Children’s drugs may cause reye syndrome, after see 【 side effect 】.

(note: other content such as do not agree with the above revised requirements, should be revised.)

(formerly called “attention! With lai ammonia injection instruction to amend the” Lin)

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