Colistin/Norma
 Trade Name
 Colistin/Norma 
ΑTC_Code
 J01XB01 
Active Substance
 
Phamaceutical Form
 DR.PD. INJ  
Composition
 1000000u/vial 
Product Id
 10010
Specification

COLISTIN / NORMA

SPECIFIC PRODUCT CHARACTERISTICS
( SPC)

- Trade Name of the Medicinal Product
COLISTIN / NORMA

- Qualitive and Quantitative Composition
Each vial contains 75 mg Colistin Messilate Sodium, equivalent to 1.000.000 IU.

- Pharmaceutical Form
Powder for the preparation of injectable solution.

- Clinical Particulars

- Contraindications
Hypersensitivity to Colistin, myasthenia.

- Special Warnings and Precautions for Use
Intramuscular administration of Colistin Methanesulfonate Sodium in patients with renal dysfunction results in maintenance of high blood concentrations of Colistin. Consequently the administered doses should be adjusted depending on the disorder of the renal function.

- Interactions with other Drugs and other Forms of Interaction
There have been reports of incompatibility with the following: Carbenicillin Sodium, Cephalothin Sodium, Cephazolin Sodium, Erythromycin Lactobionate, Hydrocortisone Sodium Succinate, Kanamycin Sulfate, Lincomycin Hydrochloride eae Sucralfate.

- Pregnancy and Lactation
The benefit from the administration of Colistin should outweigh the possible risks during pregnancy and lactation.

- Effect on the Ability to Drive and Use Machines
None

- Undesirable Effects
When Colistin Messilate Sodium is given parenterally the adverse events are rare, demonstrated usually as pruritus, skin diseases, vertigo e.t.c. and are transient.
Adverse events concerning the kidneys are more rare than those provoked by the administration of Polymyxin B. In most rare cases elevation of the blood urea and symptoms of renal impairment have been reported following administration of high dosages in patients with renal dysfunction. It is possible for apnea to be developed following intramuscular administration as well as neuromuscular blockage. These events are enhanced in renal impairment. It should be also mentioned the neurotoxicity of Colistin.

- Overdosage
Symptomatic therapeutic treatment is recommended.
Telephone of Athens Poisoning Center: +30 210 7793777

- Pharmacological Properties
- Pharmacodynamic Properties
Colistin is an antibiotic produced by strains of Bacillus Polymyxavan spp. Its antimicrobial spectrum is the same with Polymyxin B.
Colistin is active against all Gram microorganisms, except for Proteus spp.
Chemically, Colistin is a polypeptide soluble in water, stable to temperature, time and also resistant in acid and alkaline media.
Colistin is not toxic, even when the therapeutic doses administered reach maximum limits.
Colistin does not provoke renal disturbances, hematological disorders, neurical symptoms, vitamins deficiency, moniliales and allergic reactions as it occurs with other antibiotics.
The measurement units of Colistin are expressed depending on the lower condensation of the antibiotic per each cm3 culture juice, required for the total inhibition of growth of a special strain of Escerichia Coli.

- Pharmacokinetics Properties
Colistin Methanesulfonate Sodium
Chemically it is the sodium salt of sulfo- methyl- derivative of Colistin. At the tissues is hydrolyzed to Colistin. During intramuscular administration the release of the antibiotic takes place slowly at the injection site. This property to act as Depot results in the maintenance of blood concentrations.
The maximum blood concentration is reached 30-60 minutes after administration and is preserved for 6 hours. The intramuscular administered dose of the antibiotic is mainly excreted in the urine and, although it is slowly absorbed, significant biotherapeutic concentrations in the urine are achieved.

- Preclinical Safety Data
Intramuscular administration of Colistin Methanesulfonate Sodium in patients with renal dysfunction results in maintenance of high blood concentrations of Colistin. Consequently the administered doses should be adjusted depending on the disorder of the renal function.

- Pharmaceutical Particulars

- Incompatibilities
There have been reports of incompatibility with the following: Carbenicillin Sodium, Cephalothin Sodium, Cephazolin Sodium, Erythromycin Lactobionate, Hydrocortisone Sodium Succinate, Kanamycin Sulfate, Lincomycin Hydrochloride eae Sucralfate.

- Shelf Life
The product is maintained for 36 months before reconstitution and preserves its stability for 2 hours after reconstitution.

- Special Precautions for Storage
Store in room temperature.

Keep away from the sight and reach of children.

- Nature and Contents of the Container
Glass vials for inj. solution with caps for sterile products.

- Instructions for Use
Intramuscular Administration
Preparation of the solution for injection: The content of one vial is dissolved in sterile, isotonic solution of sodium chloride. It can also be used an isotonic solution of dextrose or water for the preparation of the solution for injections depending on the doctor’s judge.

Infusion in cavities
For infusion in the peritoneal cavity or the pleura cavity the content of one vial is dissolved in 50 ml of sterile solution of sodium chloride.

厂家：NORMA Hellas A.E.

1 BOX * 1 VIAL     1000000[iU]/VIAL