Chapter I General Provisions
Article 1 These Provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China.
article 2 the instructions and labels of drugs listed and sold in the people's Republic of China shall meet the requirements of these provisions.
article 3 drug instructions and labels shall be approved by the state food and drug administration.
The labels of drugs should be based on the instructions, and their contents should not go beyond the scope of the instructions, and words and labels that imply curative effect, mislead use and improperly publicize the products should not be printed.
article 4 drug packages must be printed or labeled according to regulations, and no other words, audio-visual and other materials that introduce or publicize products and enterprises may be included.
the minimum package produced by a pharmaceutical manufacturer for marketing must be accompanied by instructions.
article 5 the written expression of drug instructions and labels shall be scientific, standardized and accurate. Instructions for over-the-counter drugs should also be expressed in easy-to-understand words, so that patients can judge, choose and use them by themselves.
article 6 the words in drug instructions and labels should be clear and legible, and the labels should be clear and eye-catching, and there should be no phenomenon such as the printed words falling off or the paste is not firm, and it is not allowed to be modified or supplemented by pasting, cutting or altering.
article 7 standardized Chinese characters published by state language commission should be used in drug instructions and labels. if other characters are added for comparison, the Chinese characters shall prevail.
article 8 for the purpose of protecting public health and guiding the correct and rational use of drugs, pharmaceutical production enterprises may take the initiative to put warnings on drug instructions or labels, and the state food and drug administration may also require pharmaceutical production enterprises to put warnings on drug instructions or labels.
chapter ii drug instructions
article 9 drug instructions shall contain important scientific data, conclusions and information on the safety and effectiveness of drugs to guide the safe and rational use of drugs. The specific format, content and writing requirements of drug instructions shall be formulated and promulgated by the State Food and Drug Administration.
article 1 the description of disease names, pharmaceutical terms, drug names, clinical test names and results in drug instructions shall adopt special words uniformly promulgated or standardized by the state, and the units of measurement shall conform to the provisions of national standards.
article 11 the drug instructions shall list all the active ingredients or all the traditional Chinese medicines in the prescription. Injections and over-the-counter drugs should also list the names of all excipients used.
if the drug prescription contains ingredients or auxiliary materials that may cause serious adverse reactions, it shall be explained.
article 12 pharmaceutical production enterprises shall actively follow up the safety and effectiveness of drugs after they are put on the market, and if it is necessary to modify the drug instructions, they shall apply in time.
according to the monitoring of adverse drug reactions, the results of drug re-evaluation, and other information, the State Food and Drug Administration may also require pharmaceutical manufacturers to modify the drug instructions.
article 13 after the drug instructions are approved to be revised, the drug manufacturer shall immediately notify the relevant drug trading enterprises, users and other departments of the revised contents, and use the revised instructions and labels in a timely manner as required.
article 14 drug instructions shall fully contain information on adverse drug reactions, and specify the adverse drug reactions in detail. If a pharmaceutical production enterprise fails to modify the instructions in time according to the safety and effectiveness of the drugs after listing, or fails to fully explain the adverse drug reactions in the instructions, the adverse consequences arising therefrom shall be borne by the production enterprise.
article 15 the date of approval and the date of revision of the drug instructions should be clearly marked in the instructions.
chapter iii labeling of drugs
article 16 labeling of drugs refers to the contents printed or affixed on the packaging of drugs, which are divided into internal labels and external labels. The inner label of a drug refers to the label that directly contacts the package of the drug, and the outer label refers to the label of other packages other than the inner label.
article 17 the internal label of a drug shall include the generic name, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, manufacturer, etc.
if the package size is too small to indicate all the above contents, at least the generic name, specifications, product batch number, expiration date and other contents of the drug shall be indicated.
article 18 the external label of a drug shall indicate the generic name, ingredients, properties, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval number, manufacturer and other contents. If indications or functional indications, usage and dosage, adverse reactions, contraindications and precautions cannot all be indicated, the main contents shall be marked and the words "see the instructions for details" shall be indicated.
article 19 the label of the package used for transportation and storage shall at least indicate the general name, specifications, storage, production date, product batch number, expiration date, approval number and production enterprise of the drug, and may also indicate the necessary contents such as the number of packages, transportation precautions or other marks as required.
Article 2 The label of an API shall indicate the drug name, storage, production date, product batch number, expiration date, implementation standard, approval number, and manufacturer, and shall also indicate the necessary contents such as packaging quantity and transportation precautions.
Article 21 If the specifications and packaging specifications of the same drug produced by the same pharmaceutical manufacturer are the same, the contents, formats and colors of the labels must be the same; If the drug specifications or packaging specifications are different, the labels shall be clearly distinguished or the specifications shall be clearly marked.
if the same drug produced by the same pharmaceutical manufacturer is managed according to prescription drugs and over-the-counter drugs respectively, the packaging colors of the two drugs should be obviously different.
article 22 drugs with special storage requirements shall be clearly marked on the label.
article 23 the expiration date in the drug label shall be marked in the order of year, month and day, with the year being represented by four digits and the month and daily use being represented by two digits. Its specific labeling format is "valid until XX, XXXX" or "valid until XX, XXXX"; It can also be expressed by numbers and other symbols as "valid until XXXX.XX" or "valid until XXXX/XX/XX" and so on.
the labeling of the expiration date of preventive biological products shall be carried out according to the registration standards approved by the State Food and Drug Administration. The labeling of the expiration date of therapeutic biological products shall be calculated from the packaging date, and the labeling of the expiration date of other drugs shall be calculated from the production date.
if the validity period is marked on the day, it should be the day before the starting date corresponds to the month, and if it is marked on the month, it should be the month before the starting month corresponds to the month.
Chapter IV Use of Drug Names and Registered Trademarks
Article 24 The names of drugs marked in drug instructions and labels must conform to the naming principles of common drug names and trade names published by the State Food and Drug Administration, and be consistent with the corresponding contents of drug approval documents.
Article 25 The generic name of a drug shall be conspicuous and prominent, and its font, font size and color shall be consistent, and the following requirements shall be met:
(1) The horizontal label shall be marked in a prominent position within the upper third; For the vertical label, it must be marked in a prominent position within the right third;
(2) Don't use cursive script, seal script and other difficult-to-identify fonts, and don't use italics, hollows, shadows and other forms to modify fonts;
(3) The font color should be black or white, which is in sharp contrast with the corresponding light or dark background;
(4) Unless it is impossible to write in the same trade due to the limitation of package size, it is not allowed to write in branches.
Article 26 A drug trade name shall not be written with a generic name, its font and color shall not be more prominent and conspicuous than the generic name, and its font shall not be more than half of the font used in the generic name in terms of single word area.
article 27 unregistered trademarks and other drug names that have not been approved by the state food and drug administration are prohibited in drug instructions and labels.
where a registered trademark is used in a drug label, it shall be printed on the corner of the drug label. if it contains words, the font shall not be larger than a quarter of the font used in a generic name in terms of single word area.
Chapter V Other Provisions
Article 28 Where narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs have special labels as stipulated by the state, their instructions and labels must be printed with the specified labels.
if the state has special provisions on drug instructions and labels, those provisions shall prevail.
article 29 the provisions on the label management of Chinese herbal medicines and Chinese herbal pieces shall be formulated separately by the state food and drug administration.
article 3 if the instructions and labels of drugs do not conform to these provisions, they shall be punished in accordance with the relevant provisions of the drug administration law of the people's Republic of China.
Chapter VI Supplementary Provisions
Article 31 These Provisions shall come into force as of June 1, 26. The Regulations on the Administration of Drug Packaging, Labeling and Instructions (Provisional) issued by National Medical Products Administration on October 15th, 2 shall be abolished at the same time.
this is the required
AmoxicillinSodiumforInjection
standard source
drug name
common name: amoxicillin sodium for injection product name: English name: amoxicillin sodium for injection Chinese pinyin: ZhusheyongAmoxilingna The main component of this product is amoxicillin sodium, and its chemical name is (2S,5R,6R)-3. 3- dimethyl -6-[(R)-(-)-2- amino -2-(4- hydroxyphenyl) acetamido ]-7- oxo -4- thio -1- azabicyclo [3.2.] heptane -2- sodium formate Its structural formula is: molecular formula: C16H18N3NaO5S molecular weight: 387.4
ingredients
properties
This product is white or off-white powder or crystal.
Action category
Pharmacology and toxicology
Amoxicillin is a penicillin antibiotic, which has good antibacterial activity against Streptococcus pneumoniae, hemolytic Streptococcus and other aerobic gram-positive cocci, Escherichia coli, Proteus mirabilis, Salmonella, Haemophilus influenzae, Neisseria gonorrhoeae and other aerobic gram-negative bacteria, and Helicobacter pylori. Amoxicillin plays a bactericidal role by inhibiting the synthesis of bacterial cell wall, which can make bacteria quickly become spheroids and dissolve and rupture.
pharmacokinetics
after intramuscular injection of .5g amoxicillin sodium, the peak time is 1 hour, and the peak plasma concentration (Cmax) is 14mg/L, which is similar to that after oral administration of the same dose of amoxicillin. The blood concentration was 42.6mg/L 5 minutes after intravenous injection of .5g, and 1mg/L 5 hours later. This product is well distributed in most tissues and body fluids. The drug concentration in cerebrospinal fluid was 2.9 ~ 4. mg/L 1.5 hours after intravenous injection of 2g of this product. This product can pass through the placenta, and its concentration in umbilical cord blood is 1/4 ~ 1/3 of that in maternal blood, and it also contains trace amounts in milk, sweat and tears. The protein binding rate of amoxicillin is 17% ~ 2%. Blood elimination half-life (t1/2? ) for 1.8 hours, more than 6% of the drug was excreted from urine, about 24% of the drug was metabolized in the liver, and a small amount was excreted through biliary tract. The serum half-life of patients with severe renal insufficiency can be extended to 7 hours. Hemodialysis can remove this product, while peritoneal dialysis has no effect.
indications
amoxicillin is suitable for patients with the following infections caused by sensitive bacteria (β-lactamase-producing strains) who are seriously ill and need hospitalization or cannot be taken orally. 1. Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis and tonsillitis caused by Streptococcus hemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae. 2. Urogenital tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis. 3. Skin and soft tissue infections caused by hemolytic streptococcus, staphylococcus or Escherichia coli. 4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by Streptococcus hemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae. 5. This product can be used to treat typhoid fever and leptospirosis.
usage and dosage
intramuscular injection or intravenous drip after dilution. .5 ~ 1g for adults, once every 6 ~ 8 hours. The daily dose of children is 5 ~ 1 mg/kg, divided into 3 ~ 4 times. Patients with severe renal function damage need to adjust the dosage, in which patients with endogenous creatinine clearance rate of 1 ~ 3 ml/min are .25 ~ .5 g every 12 hours; Patients whose endogenous creatinine clearance rate is less than 1ml/ min are .25～.5g every 24 hours. Hemodialysis can remove this product, and amoxicillin 1g should be given after each hemodialysis.
Adverse reactions
1. Gastrointestinal reactions such as nausea, vomiting, diarrhea and pseudomembranous enteritis. 2. Allergic reactions such as rash, drug fever and asthma. 3. Anemia, thrombocytopenia and eosinophilia. 4. Serum aminotransferase can be slightly increased. 5. Double infection caused by candida or drug-resistant bacteria. 6. Occasionally, symptoms of the central nervous system such as excitement, anxiety, insomnia, dizziness and abnormal behavior are seen.
contraindications
patients with penicillin allergy and positive penicillin skin test are prohibited.
Precautions
1. Penicillins can occasionally cause anaphylactic shock, especially in patients with allergic history of penicillin or cephalosporins. Before taking medicine, we must ask about the history of drug allergy in detail and do penicillin skin test. If anaphylactic shock occurs, it should be rescued on the spot, and the airway should be kept clear, oxygen should be inhaled, and adrenaline and glucocorticoid should be used. 2. Patients with infectious mononucleosis are prone to rash when using this product, and should avoid using it. 3. Patients with a long course of treatment should check their liver, renal function and blood routine. 4. Amoxicillin can lead to false positive in urine glucose test with Benedit or Fehling reagent. 5. The following conditions should be used with caution: (1) those with a history of allergic diseases such as asthma, eczema, hay fever, urticaria, etc. (2) The dosage may need to be adjusted for the elderly and severely damaged renal function.
Pregnant women and lactating women take drugs
Animal reproductive tests show that the dose of amoxicillin 1 times that of human does not damage the fertility and fetus of rats and mice. However, there are not enough controlled studies in humans. In view of the fact that animal reproduction tests can not completely predict human reactions, pregnant women should only use this product when it is really necessary. Because a small amount of amoxicillin can be secreted in milk, it may cause baby allergy after taking it by lactating mothers.
children
elderly patients
drug interaction
1. Probenecid competitively reduces the renal tubular secretion of this product, and the simultaneous application of the two drugs can increase the blood concentration of amoxicillin and prolong the half-life; 2. Chloramphenicol, macrolides, sulfonamides and tetracyclines interfere with the antibacterial effect of amoxicillin in vitro, but their clinical significance is unknown.
drug overdose
in a prospective study involving 51 children, it was suggested that the dosage of amoxicillin did not cause significant clinical symptoms when it did not exceed 25mg/Kg. It has been reported that a few patients have renal insufficiency and oliguria due to amoxicillin overdose, but the renal function damage can be reversed after stopping the drug.
specifications
press C16H1.