Gentamicin Injection
Composition
The main ingredient of this product is gentamicin sulfate. It is a multi component antibiotic containing C1, C1a, C2a, C2 and other components.
Indication
1.It is suitable for the treatment of severe gram-negative bacilli, such as Escherichia coli, Klebsiella, enterobacter, proteus, Sarre, Pseudomonas aeruginosa, and Staphylococcus methicillin sensitive strains, such as septicaemia, lower respiratory tract infection, intestinal infection, pelvic infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdomen Cavity infection, skin and soft tissue infection, complicated urinary tract infection and so on. The treatment of abdominal infection and pelvic infection should be combined with anti anaerobic drugs. Gentamicin is commonly used in combination with other antibiotics. Combination with penicillin (or ampicillin) can treat enterococci infection.
2. It is suitable for the treatment of central nervous system infection caused by sensitive bacteria, such as meningitis and ventriculitis, intrathecal injection of this product can also be used as adjuvant therapy.
Usage and dosage
Intramuscular injection or diluted intravenous infusion: once 80mg (80 thousand units) 2~3 times a day for 8 hours. The children were given 3 to 5mg (3000~5000 units) per kilogram of body weight each day, divided into 2~3 doses.
Adverse reaction
1.during the course of medication, it may cause hearing loss, tinnitus or ear fullness, which can cause instability and vertigo when affecting vestibular function. There may also be hematuria, voiding frequency significantly reduced or urine loss, loss of appetite, extreme thirst and other toxic reactions. Low incidence of dyspnea, drowsiness, weakness and so on caused by neuromuscular block or nephrotoxicity. Occasionally there were rash, nausea, vomiting, hypothyroidism, leukocytic reduction, granulocytic anemia, anemia, hypotension, and so on.
2. a small number of patients with hearing loss, tinnitus or ear fullness after withdrawal can cause ototoxic symptoms.
3. systemic administration combined with intrathecal injection may cause leg convulsions, rashes, fever and general spasms.
Contraindication
prohibits the allergy to this product or other aminoglycosides.
Precautions
1 caution should be taken in the following situations: loss of water, eighth damage to the cranial nerves, myasthenia gravis, Parkinson's disease and renal impairment.
2 cross anaphylaxis, which is allergic to an aminoglycoside antibiotic such as streptomycin and Amikacin, may be allergic to this product.
3 regular urine routine tests and renal function tests should be performed before and during the use of drugs to prevent severe renal toxicity. If necessary, do audiological examination or listen to electrogram, especially high frequency audiometry and temperature stimulation test to detect vestibular toxicity.
4 the blood concentration should be monitored during the course of treatment and adjusted according to the dosage, especially for the neonates, the elderly and the patients with renal dysfunction. The effective blood concentration should be maintained at 4 ~ 10mg/ml every 8 hours and 1 times, the peak concentration should be avoided more than 12mg/ml, the concentration of the valley remained from 1 to 2mg/ml, and the concentration of the blood drug peak should be kept at 16 to 24mg/ml for 1 times per 24 hour, and the valley concentration should be < 1mg/ml. Intrathecal injection should also monitor the concentration of CSF.
5 when blood concentration is not determined, dosage should be adjusted according to the creatinine clearance rate.
6 after giving the first saturated dose (1 to 2mg/kg), the maintenance dosage of patients with renal insufficiency, vestibular function or hearing loss should be reduced. 7 patients should be given enough water to reduce damage to the renal tubules.
8 long term application may lead to overgrowth of drug-resistant bacteria.
9 should not be used for subcutaneous injection.
10 this product can inhibit respiration and not intravenous injection.
11 interference of diagnosis: This product can increase the determination of alanine aminotransferase (ALT), aspartate aminotransferase (GOT), serum bilirubin concentration and lactate dehydrogenase (LDH) concentration; the determination of blood calcium, magnesium, potassium and sodium may decrease.
Special groups
Attention to children:
Gentamicin is a kind of aminoglycoside, which should be used carefully in pediatrics, especially in premature infants and neonates. Because the kidney has not been fully developed, the half-life of this kind of drug is prolonged, and it is easy to accumulate in the body to produce toxic reaction.
Notice of pregnancy and lactation:
This product can pass through the placental barrier to enter the fetal tissue, and may cause hearing damage to the fetus. Pregnant women should fully weigh the pros and cons before using this product. This product has very little secretion in milk, but usually breastfeeding women should stop breastfeeding during the medication period.
Matters needing attention by the elderly:
The renal function of elderly patients has a certain degree of physiological decline. Even if the renal function is within the normal range, a smaller amount of treatment should be adopted. It is easy for elderly patients to produce various toxic reactions after using this product. Blood concentration should be monitored as far as possible during the course of treatment.
Product foto
Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH.\
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.
Our Quality control system
In manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:
Our Registration Team and technical support
We have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.
We can provide regulatory documents
Composition
The main ingredient of this product is gentamicin sulfate. It is a multi component antibiotic containing C1, C1a, C2a, C2 and other components.
Indication
1.It is suitable for the treatment of severe gram-negative bacilli, such as Escherichia coli, Klebsiella, enterobacter, proteus, Sarre, Pseudomonas aeruginosa, and Staphylococcus methicillin sensitive strains, such as septicaemia, lower respiratory tract infection, intestinal infection, pelvic infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdominal infection, abdomen Cavity infection, skin and soft tissue infection, complicated urinary tract infection and so on. The treatment of abdominal infection and pelvic infection should be combined with anti anaerobic drugs. Gentamicin is commonly used in combination with other antibiotics. Combination with penicillin (or ampicillin) can treat enterococci infection.
2. It is suitable for the treatment of central nervous system infection caused by sensitive bacteria, such as meningitis and ventriculitis, intrathecal injection of this product can also be used as adjuvant therapy.
Usage and dosage
Intramuscular injection or diluted intravenous infusion: once 80mg (80 thousand units) 2~3 times a day for 8 hours. The children were given 3 to 5mg (3000~5000 units) per kilogram of body weight each day, divided into 2~3 doses.
Adverse reaction
1.during the course of medication, it may cause hearing loss, tinnitus or ear fullness, which can cause instability and vertigo when affecting vestibular function. There may also be hematuria, voiding frequency significantly reduced or urine loss, loss of appetite, extreme thirst and other toxic reactions. Low incidence of dyspnea, drowsiness, weakness and so on caused by neuromuscular block or nephrotoxicity. Occasionally there were rash, nausea, vomiting, hypothyroidism, leukocytic reduction, granulocytic anemia, anemia, hypotension, and so on.
2. a small number of patients with hearing loss, tinnitus or ear fullness after withdrawal can cause ototoxic symptoms.
3. systemic administration combined with intrathecal injection may cause leg convulsions, rashes, fever and general spasms.
Contraindication
prohibits the allergy to this product or other aminoglycosides.
Precautions
1 caution should be taken in the following situations: loss of water, eighth damage to the cranial nerves, myasthenia gravis, Parkinson's disease and renal impairment.
2 cross anaphylaxis, which is allergic to an aminoglycoside antibiotic such as streptomycin and Amikacin, may be allergic to this product.
3 regular urine routine tests and renal function tests should be performed before and during the use of drugs to prevent severe renal toxicity. If necessary, do audiological examination or listen to electrogram, especially high frequency audiometry and temperature stimulation test to detect vestibular toxicity.
4 the blood concentration should be monitored during the course of treatment and adjusted according to the dosage, especially for the neonates, the elderly and the patients with renal dysfunction. The effective blood concentration should be maintained at 4 ~ 10mg/ml every 8 hours and 1 times, the peak concentration should be avoided more than 12mg/ml, the concentration of the valley remained from 1 to 2mg/ml, and the concentration of the blood drug peak should be kept at 16 to 24mg/ml for 1 times per 24 hour, and the valley concentration should be < 1mg/ml. Intrathecal injection should also monitor the concentration of CSF.
5 when blood concentration is not determined, dosage should be adjusted according to the creatinine clearance rate.
6 after giving the first saturated dose (1 to 2mg/kg), the maintenance dosage of patients with renal insufficiency, vestibular function or hearing loss should be reduced. 7 patients should be given enough water to reduce damage to the renal tubules.
8 long term application may lead to overgrowth of drug-resistant bacteria.
9 should not be used for subcutaneous injection.
10 this product can inhibit respiration and not intravenous injection.
11 interference of diagnosis: This product can increase the determination of alanine aminotransferase (ALT), aspartate aminotransferase (GOT), serum bilirubin concentration and lactate dehydrogenase (LDH) concentration; the determination of blood calcium, magnesium, potassium and sodium may decrease.
Special groups
Attention to children:
Gentamicin is a kind of aminoglycoside, which should be used carefully in pediatrics, especially in premature infants and neonates. Because the kidney has not been fully developed, the half-life of this kind of drug is prolonged, and it is easy to accumulate in the body to produce toxic reaction.
Notice of pregnancy and lactation:
This product can pass through the placental barrier to enter the fetal tissue, and may cause hearing damage to the fetus. Pregnant women should fully weigh the pros and cons before using this product. This product has very little secretion in milk, but usually breastfeeding women should stop breastfeeding during the medication period.
Matters needing attention by the elderly:
The renal function of elderly patients has a certain degree of physiological decline. Even if the renal function is within the normal range, a smaller amount of treatment should be adopted. It is easy for elderly patients to produce various toxic reactions after using this product. Blood concentration should be monitored as far as possible during the course of treatment.
Product foto
Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH.\
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.
Our Quality control system
In manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:
- Initial inspection (such as raw material, excipients, package materials, etc.)In-process inspection (make sure that each testing items should be qualified )Final inspection before shipment of each order. Provide temperature control recorder when it is necessary for special market before loading.
Our Registration Team and technical support
We have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.
We can provide regulatory documents
- GMP Certificate / CE CertificateFree sales certificate Certificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.