Basic Info.
Application
Internal Medicine
Suitable for
Elderly, Children, Adult
Pharmaceutical Technology
Chemical Synthesis
Product Description
DESCRIPTION
CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester
of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg
disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Clindamycin is a
semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent
compound lincomycin.
INDICATIONS AND USAGE
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.
Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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.
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 Certificate
Free sales certificate
Certificate of Pharmaceutical Products
Manufacture License
CTD Dossier.
Address:
Xingda Business Centre, No. 24 Bayi Road, Lanshan District, Linyi, Shandong, China
Business Type:
Manufacturer/Factory, Trading Company, Group Corporation
Business Range:
Chemicals, Health & Medicine, Service
Management System Certification:
ISO 9001, ISO 9000, GMP, LEED
Company Introduction:
Shandong Synta Pharma Co., Ltd. (SSP) is a different kind of pharmaceuticals (both finished medicine products and raw materials), health products and medical supplies company for human needs, focusing on global markets, especially the developing world. Working with the highest levels of government and local distributors alike, we aim to not only expand our business scale and scope but also have a special interest in serving the needs of the end consumer that requires our products the most. To this end, we have a presence in 5 continents with an expanding product range to meet the demand of our main markets.
Moreover, our manufacturing facilities follow strict GMP rules and regulations. We have intergraded all GMP guidelines into internal procedures improving the degree to which results are consistently exceeding expectations. As one of the best pharmaceutical companies in China, we take our ethical obligation to improving access to high quality and affordable WHO essential drugs seriously. This is the ethical basis our company was founded on.
){kind=link}