Nufirom

Composition :

Each vial NUFIROM® contain 1.433 g dry powder which contain Cefpirome sulfate 1.190 g equivalent with 1.0 g Cefpirome

 

Pharmacology:

NUFIROM® with active ingredients Cefpirome belongs to fourth generation cephalosporin antibiotics that have antibacterial activity by inhibiting bacterial cell wall synthesis and have broad activity against gram positive and gram negative organisms including aerobic and anaerobic bacteria. Cefpirome has a high stability against ß (beta) – lactamase. Penetration of Cefpirome into the tissues is excellent and is distributed rapidly to all body fluid.

In vitro Cefpirome is sensitive to :

  • Gram positive bacteria :

Streptococcus haemolytic and non haemolytic, Streptococcus pyogenes ( group A ), Streptococcus from serogroup B and F, Streptococcus viridans group, Streptococcus pneumoniae, Streptococcus agalactiae, Corynebacterium spp, Enterococcus faecalis, Staphylococcus aureus and coagulase negative epidermidis, Staphylococcus saprophyticus, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus spp, ( Methicillin – resistant straine ), Enterococcus faecium, Listeria monocytogenes, Clostridium difficile.

  • Gram negative bacteria :

Neisseria spp, Citrobacter spp, Salmonella spp, Escherichia coli, Enterobacter spp, Haemophillus influenzae and other spesies Haemophillus, Indol positive and Indol negative Klebsiella spp and Proteus spp, Hafnia alvei, Morganella morganii, Pasteurella multocida, Providencia spp, Serratia marcescens, Moraxella catarrhalis, Alcaligines spp, Bacteroides spp, Acinetobacter calcoaceticus, Pseudomonas aeruginosa and other spesies Pseudomonas, Citrobacter spp, Anthomonas maltophilia, Fusobacterium varium, Bacteroides fragilis ( Beta – lactamase – producing strains ).

 

Indication :

NUFIROM® is effective for treatment of infections which caused by microorganisms that are sensitive to Cefpirome such as:

  • Complicated lower and upper urinary tract infections (pyelonephritis).
  • Lower respiratory tract infections (bronchopneumonia and lobar pneumonia).
  • Neutropenic infections (except which caused by Pseudomonas aeruginosa) and patients with decreased immune systems.
  • Skin and soft tissue infections (cellulitis, skin abcession and wound infection)
  • Septicaemia.
  • Severe infections in patients with intensive care.

 

Dosage and Administration :

Dosage and administration depends on the condition of infection and sensitivity of the pathogen, the condition of the patient and renal function.

Below is the dose table for adults with normal renal function:

 

Type of infection

 Disposable dosage

Interval

 Total daily dose
Complicated lower and upper urinary tract infections 1 g 12 jam 2 g
Skin and soft tissue infections 1 g 12 jam 2 g
Lower respiratory tract infections 1 g/2 g 12 jam  

2 g/4 g

 
Septicaemia 2 g 12 jam 4 g
Neutropenic infections / patients with decrease immune systems 2 g 12 jam 4 g
Severe infection/ patients with intensive care 2 g 12 jam 4 g

 

For urinary tract, skin and soft-tissue infections, a single dose can be increased up to 2 grams in severe cases.

 

Dosage for patients with renal dysfunction conditions should be adjusted. Here is the recommended dose:

 

( Creatinine clearance )

Dosage
> 50 ml/minute The daily dose is the same as recommended for normal renal function.

2 times 1 gram to 2 times 2 grams
Arrangement doses in patients with impaired renal function
Severe infection Very severe infection
1 g as initial dose, then: 2 g as initial dose, then:
50 – 20 ml/minute 2 times 0.5 gram 2 times 1 gram
20 – 5 ml/minute 1 time 0.5 gram 1 time 1 gram
< 5 ml/menit ( hemodialisa ) 1 time 0.5 gram, with additional 0.25 gram immediately after dialisa 1 time 1 gram, with additional 0.5 gram immediately after dialisa

 

Based on the level of serum creatinine, creatinine clearance can be calculated using the equation COCKLOFT’S:

  • Men: creatinine clearance (ml/min)

 

Body weight (kg) x (140-age on years)

73 x serum creatinine (mg/dl)

 

  • Women: The equation is multiplied by 0.85

 

Instructions for use:

  • Patients with impaired renal function: the initial dose as usual.
  • Patients with impaired renal function (creatinine clearance 20-50 ml / min): maintenance dose 0.5 – 1.0 gram, twice daily.
  • Patients with impaired renal function (creatinine clearance 5-20 ml / min): maintenance dose 0.5 – 1.0 gram, once daily.
  • Patients with impaired renal function (creatinine clearance <5 ml / min): maintenance dose 0.5 – 1.0 grams, once daily, in patients receiving hemodialysis conditions, 0.25 – 0.5 grams should be added immediately after the dialysis process.

 

Dissolve the solution :

For making solution injection add 10 ml of aqua pro injection into the vial containing Cefpirome 1 g, and when the injection aqua pro is added to the powder there will be an increase in pressure caused by CO2 gas so the needle is heavy. Therefore, to reduce the pressure is then push on the vial cap with a syringe that has been provided. The occurrence of CO2 gas does not affect the efficacy and effectiveness of the drug. A clear yellow solution after being completely dissolved.

 

Stages Dissolve NUFIROM® Injection :

  1. Fill syringe with aqua pro injection that has been provided as much as 10 ml.
  2. Push the little needle that has been provided into vial NUFIROM® injection with the upright position. Then stick the needle syringe that has a 10 ml aqua pro injection on the side. Press the end of the syring containing the injection aqua pro slowly to the ground and when the aqua pro injection mixes with the powder will arise CO2 gas.
  3. In the upright position shake slowly until the powder of NUFIROM® solvent injection soluble perfectly and obtained a clear yellow solution. Then the small needle is pulled out. The injection syringe position is still in its original position.
  4. Invert the vial and suction solution into the syringe then use in accordance with the specified dose.

 

Administration :

Intra venous injection

NUFIROM® 1 g is completely dissolved with a 10 ml aqua pro injection then injected directly into the vein or through the distal portion of the IV tube for 3 – 5 minutes.

 

Short intra venous infusion

NUFIROM®1 g is completely dissolved with 100 ml aqua pro injection and then infused for 20 – 30 minutes. Some of infusion solutions that can be used include: 0.9% NaCl solution, ringer solution, electrolyte solution, 5% and 10% glucose solution, 5% fructose solution, 6% glucose solution + 0.9% NaCl solution. NUFIROM® should not be administered with sodium bicarbonate solution. NUFIROM® should be used immediately after reconstitution, and if stored in the refrigerator the solution is stable for 24 hours. Color changes may occur during storage but this does not affect the efficacy and effectiveness of the drug.

 

Presentation and Registration Number :

NUFIROM® Box 1 vial @ 1.433g dry powder + 1 ampoule @ 10 ml aqua pro injection; DKL 0608014044A1

 

ON MEDICAL PRESCRIPTION ONLY

 

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