GMP Certified / Clindamycin Phosphate Injection 2ml: 0.3G

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 2ml: 0.3g
• Model NO.: injection
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Clindamycin Phosphate Injection
Strength	2ml:0.3g
Packing	5 amps/box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Clindamycin Phosphate Injection 2ml:0.3g

Character:
This product is colorless clear or almost clear liquid.

Indications:
1. The following infectious diseases caused by Gram-positive bacteria:
(1) tonsillitis, suppurative otitis media, sinusitis, etc.
(2) Acute bronchitis, acute attack of chronic bronchitis, lung abscess and bronchiectasis combined with infection, etc.
(3) Skin and soft tissue infections: boils, carbuncles, abscesses, cellulitis, wounds, burns and post-operative infections.
(4) Urinary system infection: acute urethritis, acute pyelonephritis, prostatitis, etc.
(5) Others: osteomyelitis, septicemia, peritonitis and oral infection.
2. Various infectious diseases caused by anaerobic bacteria:
(1) Empyema, lung abscess, anaerobic pneumonia.
(2) Skin and soft tissue infection, sepsis.
(3) Abdominal infection: peritonitis, abdominal abscess.
(4) Female pelvic and genital infections: endometritis, non-gonococcal fallopian tube and ovarian abscess, pelvic cellulitis and gynecological surgery infection.

Adverse reactions:
Foreign literature shows that the adverse reactions of clindamycin phosphate injection are as follows:
1. Gastrointestinal reactions: common nausea, vomiting, abdominal pain, diarrhea, etc.; In severe cases, abdominal cramps, abdominal tenderness, severe diarrhea (watery or empyema), accompanied by fever, abnormal thirst, and fatigue (pseudomembranous enteritis). Diarrhea, enteritis, and pseudomembranous enteritis may occur at the beginning of medication or several weeks after discontinuation.
2. Blood system: Occasionally leukopenia, neutropenia, eosinophilia and thrombocytopenia may occur; Rare aplastic anemia.
3. Allergic reactions: rashes, pruritus, occasionally urticaria, angioedema and serological reactions, rare exfoliative dermatitis, bullosa dermatitis, erythema multiforme and Steven-Johnson syndrome.
4. Abnormal liver and kidney function, such as elevated serum aminotransferase, jaundice, etc.
5. Intravenous infusion may cause phlebitis; Pain, induration, and sterile abscess may occur at intramuscular injection sites.
6. Others: tinnitus, vertigo, candida infection, etc.
The adverse reactions of clindamycin phosphate and clindamycin hydrochloride injection have been reported. The use of clindamycin may cause renal function damage and hematuria. In a very small number of serious cases, adverse reactions include dyspnea, anaphylactic shock, acute renal failure, purpura, convulsions, abnormal liver function, chest tightness, palpitations, chills, high fever, dizziness, low blood pressure, tinnitus, hearing loss, etc.

Pharmacology and toxicology:
Pharmacological action
Clindamycin phosphate is a chemically synthesized clindamycin derivative, which has no antibacterial activity in vitro and is rapidly hydrolyzed into clindamycin to exert antibacterial activity.
In vitro tests have shown that clindamycin is active against the following microorganisms:
Aerobic gram-positive bacteria:
Staphylococcus aureus and Staphylococcus epidermidis (both penicillinase producing and non-penicillinase producing strains), Streptococcus (except enterococcus faecalis), pneumococcus.
Anaerobic Gram-negative Bacillus:
Bacteroides (containing Bacteroides fragilis group and Bacteroides melanogenes group) and Fusobacterium.
Anaerobic Gram-negative Spore-producing Bacillus:
Propionibacterium, Eubacterium and Actinomyces.
Anaerobic and microaerobic Gram-positive bacilli:
Peptococcus, Microaerobic Streptococcus and Peptostreptococcus genera.
Toxicological study
Genotoxicity: The Ames S. retromutation test and the rat micronucleus test were negative.
Reproductive toxicity: Oral administration of this product in rats was 0.3g/kg, which had no effect on the mating and fertility of the animals. No teratogenic effects were observed in rats and mice given oral doses of clindamycin up to 0.6g/kg or subcutaneous doses of 0.25mg/kg, respectively. However, adequate and rigorous clinical studies have not been conducted on pregnant women, and reproductive studies in animals do not fully predict human responses.
Carcinogenicity: Long-term carcinogenic potential has not been studied in animals.

Storage:
Keep in a cool and dark place (no more than 20 ° C from light).