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ZHEJIANG JINHUA CONBA BIO-PHARM.CO.,LTD


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The product description

 [Ingredients]This drug contains the active ingredient (azithromycin) and the inactive ingredient (sodium dihydrogen citrate)

Chemical name: 9-deoxy-9a-aza-erythromycin A

Chemical structure:

Molecular formula: C38H72N2O12

Molecular weight: 749.00

[Description]This drug is a white or almost white powder or lyophilised loose mass.

[Indications]This drug is used to treat the infections listed below that are caused by susceptible strains of the designated microorganisms:

1.Community-acquired pneumonia due to chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Staphylococcus aureus, or Streptococcus pneumoniae. Patients with such diseases should be treated by  the intravenous route initially.

2.Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patient who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with this drug.

[Specification] 0.5gof azithromycin per vial (equivalent tofive hundred thousand unit)

[Dosage and administration]

Prepare the initial solution of azithromycin by adding suitable quantity of sterile water for injection to the 0.5g vial and shaking the vial until all of the drug is dissolved. Transfer the initial solution into 250ml or 500ml of 0.9% sodium chloride or 5% dextrose in water, mix well to obtain 1.0-2.0mg/mL azithromycin solution. This solution is infused over a period of not less than 60 minutes. 

The recommended dose of this drug for the treatment of adult patients with community-acquired pneumonia is 0.5g (one vial) as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by oral administration of azithromycin at a singe daily dose of 0.5g, a therapy course of oral administration is 7 to 10 days. The timing of the switch to oral therapy should be done by the physician according to clinical response.

The recommended dose of this drug for the treatment of adult patients with pelvic inflammatory diseases is 0.5g as a single daily dose by the intravenous route for two days. Intravenous therapy should be followed by azithromycin by the oral rout e at a single, daily dose of 0.25g to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done by the physician according to clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with this drug. 

[Side effects]

1.Common side effects:

(1)Adverse effects of gastrointestinal system, including diarrhea, nausea, abdominal pain, loose stools, vomiting, are the most frequently reported.

(2)Adverse effects related to the intravenous infusion: pain at the injection site, local inflammation.

(3)Skin side effects: rash and pruritus.

(4)Other side effects: anorexia, dizziness, or dyspnea.

2.Side effects that may occur with a lower frequency include the following:

(1)Gastrointestinal: dyspepsia, flatulence, oral moniliasis and gastritis.

(2)Nervous system: headache, somnolence

(3)Allergic: bronchospasm

(4)Special senses: taste perversion

[Contraindications]

Patients who are sensitive to Azithromycin, Erythromycin or other macrolides antibiotics are contraindicated to use it.

[Precautions]

1.When this drug is administered to patients with impaired hepatic function, caution should be done.

2.Allergic reactions include anglioedema, dernatologic reactions, stevens johnson syndrome and toxic epidermal necrolysis. if the allergic reaction occurs during azithromycin administration, the drug should be discontinued and appropriate therapy should be instituted.

3.If patients develops diarrhea during this drug therapy, consideration should be taken whether pseudomembranous colitis may occur. If the diagnosis is confirmed, appropriate therapy should be instituted, including fluid and electrolyte management, protein supplementation and so on.

4.An intravenous infusion is not less than 60 minutes.

[Use for pregnant women and nursing mothers]

Caution should be exercised when this drug is administered to a pregnant or nursing woman.

[Pediatric use]

Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

[Geriatric use]

There are no adequate studies in older patients.

[Overdosage]

There are no adequate studiesfor this drug overdosage.

[Storage]

keep vials tightly closed, and store in a cool and dry place (not exceed 20).

[Package] Antibiotics vials: 1 vial/ box, 2 vials/ box

[Shelf life]The shelf life is defined to be “24 months” temporarily.

[Standard] Trial standard of national drugs YBH15152004

[License No.]Guo Yao Zhun Zi H20040447

[Manufacturer]

Name: Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd.

Address: 288 Jinqu road, Jinhua, Zhejiang province, China

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