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Imipenem And Cilastatin Sodium Sterile Powder For Solution For Injection 2 Years Shelf Time

Categories Sterile Powder For Injection
Brand Name: UNP/Imipenem
Model Number: 0.5g+0.5g
Certification: GMP
Place of Origin: China
MOQ: 20000VIALS
Price: USD3.0-3.15/boxFOB SHANGHAI OR GUANGZHOU
Payment Terms: L/C, T/T, Western Union, D/P
Supply Ability: 100000VIALS/MONTH
Delivery Time: 30-35days after order is setted
Packaging Details: 0.5g+0.5g/vial/20ml/box, 500boxes/carton
Product name: Ceftriaxone Sodium Powder for Injection
Appearace: White or almost white sterile powder
Composition: Each vial contains: 0.5g+0.5g
Indications: AAntibiotic, Anti-infective
Assay: >98.0%
Specification: 0.5g+0.5g
Quality standard: USP/BP
Shelf time: 2 years
Package: 0.5g+0.5g/vial/20ml/box, 500boxes/carton
Storage: Store below 25 degrees celsius. Protect from moisture. Keep out of reach of children.
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Imipenem And Cilastatin Sodium Sterile Powder For Solution For Injection 2 Years Shelf Time

GMP Certified Best Quality Imipenem and Cilastatin Sodium for Injection 0.5g+0.5g/vial/20ml/box


1. Name of the medicinal product

Cilastatin Sodium for Injection


2. Qualitative and quantitative composition

Cilastatin Sodium for Injection 0.5g+0.5g/vial


3. Pharmaceutical form

Cilastatin Sodium for Injection 0.5g+0.5g/vial Powder for solution for injection or infusion


4. Descriptions:

Imipenem and Cilastatin for Injection is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase l), with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injectionis a potent broad spectrum antibacterial agent for intravenous administration.

Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4S•H2O, and its structural formula is:


Imipenem - Structural Formula Illustration

Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:


Cilastatin sodium - Structural Formula Illustration

Imipenem and Cilastatin for Injection is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directedImipenem and Cilastatin for Injection250 contains 18.8 mg of sodium (0.8 mEq) and Imipenem and Cilastatin for Injection500 contains 37.5 mg of sodium (1.6 mEq). Solutions ofImipenem and Cilastatin for Injection range from colorless to yellow. Variations of color within this range do not affect the potency of the product.


5. Indications:

Imipenem and Cilastatin for Injectionis indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

  1. Lower respiratory tract infections. Staphylococcus aureus(penicillinase-producing strains), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae1, Klebsiella species, Serratia marcescens
  2. Urinary tract infections (complicated and uncomplicated).Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii1, Proteus vulgaris1, Providencia rettgeri1, Pseudomonas aeruginosa
  3. Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus (penicillinaseproducing strains)1, Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiellaspecies, Morganella morganii1, Proteus species, Pseudomonas aeruginosa, Bifidobacterium species, Clostridium species, Eubacteriumspecies, Peptococcus species, Peptostreptococcus species,Propionibacterium species1, Bacteroides species including B. fragilis, Fusobacterium species
  4. Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains)1, Staphylococcus epidermidis, Streptococcus agalactiae (Group B streptococci), Enterobacter species1,Escherichia coli, Gardnerella vaginalis, Klebsiella species1, Proteusspecies, Bifidobacterium species1, Peptococcus species1,Peptostreptococcus species, Propionibacterium species1, Bacteroidesspecies including B. fragilis1
  5. Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains), Enterobacter species, Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species1,Bacteroides species including B. fragilis1
  6. Bone and joint infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter species, Pseudomonas aeruginosa
  7. Skin and skin structure infections. Enterococcus faecalis, Staphylococcus aureus (penicillinaseproducing strains), Staphylococcus epidermidis, Acinetobacter species, Citrobacter species, Enterobacterspecies, Escherichia coli, Klebsiella species, Morganella morganii, Proteus vulgaris, Providencia rettgeri1, Pseudomonas aeruginosa,Serratia species, Peptococcus species, Peptostreptococcus species,Bacteroides species including B. fragilis, Fusobacterium species1
  8. Endocarditis. Staphylococcus aureus (penicillinase-producing strains)
  9. Polymicrobic infections. Imipenem and Cilastatin for Injection is indicated for polymicrobic infections including those in which S. pneumoniae (pneumonia,septicemia), S. pyogenes (skin and skin structure), or nonpenicillinaseproducing S. aureus is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.

Imipenem and Cilastatin for Injection is not indicated in patients with meningitis because safety and efficacy have not been established.


6. Side effects

Adults

Imipenem and Cilastatin for Injection is generally well tolerated. Many of the 1,723 patients treated in clinical trials were severely ill and had multiple background diseases and physiological impairments, making it difficult to determine causal relationship of adverse experiences to therapy with Imipenem and Cilastatin for Injection

Local Adverse Reactions

Adverse local clinical reactions that were reported as possibly, probably, or definitely related to therapy with PRIMAXIN I.V. were:

Phlebitis/thrombophlebitis — 3.1%
Pain at the injection site — 0.7%

Erythema at the injection site — 0.4%
Vein
induration — 0.2%
Infused vein infection — 0.1%

Systemic Adverse Reactions

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. were nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%),hypotension (0.4%), seizures (0.4%) (see PRECAUTIONS), dizziness (0.3%),pruritus (0.3%), urticaria (0.2%), somnolence (0.2%).

Additional adverse systemic clinical reactions reported as possibly, probably, or definitely drug related occurring in less than 0.2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity: Gastrointestinal — pseudomembranous colitis(the onset of pseudomembranous colitis symptoms may occur during or afterantibacterial treatment, see WARNINGS), hemorrhagic colitis, hepatitis(including fulminant hepatitis), hepatic failure, jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation;Hematologic — pancytopenia, bone marrow depression, thrombocytopenia,neutropenia, leukopenia, hemolytic anemia; CNS — encephalopathy, tremor, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances including hallucinations, dyskinesia, agitation; Special Senses — hearing loss, tinnitus, taste perversion; Respiratory — chest discomfort, dyspnea,hyperventilation, thoracic spine pain; Cardiovascular — palpitations,tachycardia; Skin — Stevens-Johnson syndrome, toxic epidermal necrolysis,erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae; Body as a whole —polyarthralgia, asthenia/weakness, drug fever; Renal — acute renal failure,oliguria/anuria, polyuria, urine discoloration. The role of Imipenem and Cilastatin for Injectionin changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.


7. Warnings:

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY W ITH BETA-LACTAMS. THESE REACTIONS ARE MORE APT TO OCCUR IN PERSONS W ITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

THERE HAVE BEEN REPORTS OF PATIENTS W ITH A HISTORY OF PENICILLIN HYPERSENSITIVITY W HO HAVE EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS W HEN TREATED W ITH ANOTHER BETA-LACTAM. BEFORE INITIATING THERAPY W ITH PRIMAXIN I.V., CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA-LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PRIMAXIN SHOULD BE DISCONTINUED.


8.Overdose:

The acute intravenous toxicity of imipenem-cilastatin sodium in a ratio of 1:1 was studied in mice at doses of 751 to 1359 mg/kg. Following drug administration, ataxia was rapidly produced and clonic convulsions were noted in about 45 minutes. Deaths occurred within 4-56 minutes at all doses.

The acute intravenous toxicity of imipenem-cilastatin sodium was produced within 5-10 minutes in rats at doses of 771 to 1583 mg/kg. In all dosage groups, females had decreased activity, bradypnea, and ptosis with clonic convulsions preceding death; in males, ptosis was seen at all dose levels while tremors and clonic convulsions were seen at all but the lowest dose (771 mg/kg). In another rat study, female rats showed ataxia, bradypnea, and decreased activity in all but the lowest dose (550 mg/kg); deaths were preceded by clonic convulsions. Male rats showed tremors at all doses and clonic convulsions and ptosis were seen at the two highest doses (1130 and 1734 mg/kg). Deaths occurred between 6 and 88 minutes with doses of 771 to 1734 mg/kg.

In the case of overdosage, discontinue PRIMAXIN I.V., treat symptomatically, and institute supportive measures as required. Imipenem-cilastatin sodium is hemodialyzable. However, usefulness of this procedure in the overdosage setting is questionable.



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