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Ceftriaxone Sodium 2g Injection
2017-04-23 03:10:48 来源: 作者: 【 】 浏览:574次 评论:0
1. Name of the medicinal product

Ceftriaxone 2g Powder for Solution for Injection or Infusion

2. Qualitative and quantitative composition

Ceftriaxone sodium equivalent to 2g ceftriaxone per vial.

Each gram of ceftriaxone sodium contains approximately 3.6 mmol sodium.

3. Pharmaceutical form

2 g Powder for Solution for injection or infusion

Powder for solution for injection or infusion.

4. Clinical particulars
 
4.1 Therapeutic indications

• Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth)

• Bacterial Meningitis

• Community acquired pneumonia

• Hospital acquired pneumonia

• Acute otitis media

• Intra-abdominal infections

• Complicated urinary tract infections (including pyelonephritis)

• Infections of bones and joints

• Complicated skin and soft tissue infections

• Gonorrhoea

• Syphilis

• Bacterial endocarditis

Ceftriaxone may be used:

For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults

For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age.

For pre-operative prophylaxis of surgical site infections

In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection

In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.

Adults and children over 12 years of age (≥ 50 kg)

Ceftriaxone Dosage*

Treatment frequency**

Indications

1 - 2 g

Once daily

Community acquired pneumonia

Acute exacerbations of chronic obstructive pulmonary disease

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

2 g

Once daily

Hospital acquired pneumonia

Complicated skin and soft tissue infections

Infections of bones and joints

2 – 4 g

Once daily

 

Management of neutropenic patients with fever that is suspected to be due to a bact

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