Netilmicin Sulfate Injection

1. Pharmacology This product is a semi-synthetic aminoglycoside antibiotic. It has strong antibacterial activity against aerobic Gram-negative bacteria. Its antibacterial spectrum is similar to that of gentamicin. It has good antibacterial effects on Escherichia coli, Pseudomonas aeruginosa, indole-negative and -positive Proteus, Klebsiella, Acinetobacter, Citrobacter, and some strains of Serratia and Enterobacter. It also has good antibacterial effects on Mycobacterium tuberculosis, atypical mycobacteria and Staphylococcus aureus (enzyme-producing and non-enzyme-producing strains). Other Gram-positive bacteria (including fecal streptococci), anaerobic bacteria, Rickettsia, fungi and viruses are not sensitive to this product. This product is stable to aminoglycoside acetyltransferase AAC (3), so strains that can produce this enzyme and are resistant to kanamycin, gentamicin, tobramycin and sisomicin are sensitive to this product. This product can often achieve synergistic effects when used in combination with lactams. The mechanism of action of this product is to bind to the 30S subunit of bacterial ribosomes and inhibit the synthesis of bacterial proteins. 2. Toxicological animal test data indicate that this product has lower ototoxicity than gentamicin and tobramycin, and lower nephrotoxicity than gentamicin.

The main ingredient of this product is: Netilmicin. Its chemical name is: O-3-deoxy-4-C-methyl-3-methylamino-?-L-arabinose pyranosyl (14)-O-[2,6-diamino-2,3,4,6-tetradeoxy-?-D-glyceryl-4-enyl hexopyranosyl-(16)]-2-deoxy-N3-ethyl-L-streptamine sulfate. ┠邗ァ) 105g; zinc chloride (ZnCl2) 13.6mg; potassium iodide (KI) 166g; sodium fluoride (NaF) 2.1mg; sorbitol (C6H14O6) 3.0g; hydrochloric acid to adjust the pH value to 2.2; water for injection is added to 10ml. Each 10ml contains: Cr30.2umol; Cu220umol; Fe320umol; Mn25umol; MoO42-0.2umol; SeO32-0.4umol; Zn2100umol; F-50umol; I-11umol; pH2.2; Osmotic pressure is about 1900mOsm/kg. Osmotic pressure is about 1900mOsm/kg.

This product is a colorless or almost colorless clear liquid.

1This product is suitable for the treatment of severe infections caused by sensitive Gram-negative bacilli. Such as neonatal sepsis, septicemia, central nervous system infection (including meningitis), urinary tract and reproductive system infection, respiratory tract infection, gastrointestinal tract infection, peritonitis, biliary tract infection, skin or bone infection, otitis media, sinusitis, soft tissue infection, listeriosis, etc. caused by Pseudomonas aeruginosa, Proteus (indole positive and negative), Escherichia coli, Klebsiella, Enterobacter, Serratia and Citrobacter. 2This product can also be used in combination with other antibacterial drugs to treat staphylococcal infections, but it is often ineffective against methicillin-resistant staphylococcal infections.

Adults with normal renal function should receive intramuscular injection or dilution and intravenous drip. 1.3-2.2 mg/kg per body weight every 8 hours; or 2-3.25 mg/kg per 12 hours; for the treatment of complicated urinary tract infection, 1.5-2 mg/kg per body weight every 12 hours. The course of treatment is 7-14 days. The maximum daily dose should not exceed 7.5 mg/kg. 1 mg/kg should be supplemented after hemodialysis. Children should receive intramuscular injection or dilution and intravenous drip. (1) Children under 6 weeks old, 2-3 mg/kg per body weight every 12 hours; (2) Children 6 weeks to 12 years old, 1.7-2.3 mg/kg per body weight every 8 hours; or 2.5-3.5 mg/kg per body weight every 12 hours. The course of treatment is 7-14 days. For intravenous infusion, dilute this product with 50-200ml sodium chloride injection, 5% glucose injection or other sterile diluent, and drip intravenously within 1.5-2 hours; the amount of diluent for children should be reduced accordingly. Slowly infuse within 1.5-2 hours. When using this product, it is advisable to monitor the blood drug concentration regularly to maintain the peak blood drug concentration at 6-10mg/L and the trough concentration at 0.5-2mg/L. 2. Patients with impaired renal function must adjust the dosage according to the degree of renal function impairment. If conditions permit, it is advisable to monitor the blood drug concentration and formulate an individualized dosing plan based on the results to adjust the blood drug concentration to the above range. It is also possible to reduce the dosage of this product or extend the dosing interval based on the measured creatinine clearance rate or reference creatinine value and blood urea nitrogen value.

1. The nephrotoxicity of this product is mild and rare. It often occurs in patients with existing renal impairment or infected patients who use doses exceeding the commonly used doses. 2. Nervous system toxicity: Toxicity of the 8th cranial nerve may occur, but compared with other commonly used aminoglycoside antibiotics, the incidence of toxicity of this product is lower and the degree is also milder. It is easy to occur in patients with existing renal impairment or infected patients with excessively high treatment doses and long courses of treatment, and manifests as symptoms of vestibular and hearing impairment, such as dizziness, vertigo, and hearing abnormalities. 3. Others: Occasionally, headache, general discomfort, visual impairment, palpitations, rash, fever, vomiting, and diarrhea may occur. 4. Local reactions are generally rare, and pain in the injection area may occur occasionally.

Patients who are allergic to this product or any aminoglycoside antibiotics or have severe toxic reactions are contraindicated.

1. Avoid using this product in combination with other nephrotoxic and neurotoxic drugs such as aminoglycoside antibiotics, vancomycin, polymyxin, strong diuretics and neuromuscular blocking drugs. 2. Mixing this product with beta-lactams (cephalosporins or penicillins) may lead to mutual inactivation. When combined use is required, it must be dripped in separate bottles; this product should not be dripped in the same bottle with other drugs.

Keep tightly closed in a cool place.

2ml: 100,000 units

24 months

Huarun Shuanghe Limin Pharmaceutical (Ji'nan) Co., Ltd.

• Founded in:

  2001-06-28

• Address:

  No. 1, Limin Road, Mingshui Street, Zhangqiu District, Jinan City, Shandong Province

• Tax NO.:

  91370181163446867C

• Registered Funds:

  23.85 million yuan

• Email:

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