Mustafa Nevzat Pharmaceuticals
Multisef
Multisef
  • Multisef IM/IV for enjection 250-750 mg, 1 vial+1 dilvent ampoule.
  • Multisef IM for enjection, 1 vial+1 dilvent ampoule with 1% lidocaine Hcl.

Composition

Each vial contains cefuroxime sodium equivalent to 250-750 mg cefuroxime

Multisef IM

Each vial contains cefuroxime sodium equivalent to 250-750 mg cefuroxime. Each diluent ampoule contains 1- 3 mL 1% lidocain hydrochloride solution. The preparation is sterile apyrogen.

Features

  • A second generation cephalosporin with a broad spectrum of activity.
  • A bactericidal antibiotic which inhibits cell-wall synthesis of the bacteria including the ß-lactamase producing strains.
  • Detectable serum levels are observed up to 8 hours after administration.
  • Well tolerated.

Spectrum of Activity

Gram-positive bacteria:

  • Staphylococcus aureus
  • Staphylococcus epidermidis
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Enterococci
  • Listeria monocytogenes

Gram-negative bacteria:

  • Haemophilus influenzae
  • Neisseria meningitidis
  • Neisseria gonorrhoeae
  • Morexella catarrhalis
  • Acinetobacter spp.
  • Pseudomonas aeruginosa
  • Enterobacter species including Enterobacter cloacea
  • Escherichia coli
  • Salmonella spp.
  • Providencia stuartii
  • Klebsiella pneumoniae
  • Serratia marcescens
  • Proteus mirabilis

Anaerobic bacteria:

  • Clostridium spp. including Clostridium difficile
  • Bacteroides spp. including Bacteroides fragilis

Indications

Multisef is indicated in the treatment of infections caused by susceptible strains of designated microorganisms in the diseases listed below:

  • Respiratory tract infections: Bronchitis, bacterial pneumonia, lung abscesses, post- operative infections.
  • Urinary tract infections: Cystitis, pyelonephritis, asymptomatic bacteriuria, gonorrhea (if penicillin is contraindicated).
  • Skin and soft tissue infections: Wound infections, erysipeloid, cellulitis, etc.
  • Bone and joint infections: Osteomyelitis, septic arthritis
  • Other infections: Meningitis, septicemia, pelvic inflammations

Contraindications

Multisef is contraindicated in patients with known hypersensitivity to cefuroxime and cephalosporins.

Warnings and Precautions

Although there is cross-resistance between penicillin and cephalosporin group of antibiotics, cefuroxime can be administered when necessary to patients with penicillin allergy. In this case it should be given with caution. In severe cases of sensitivity, epinephrine and other emergency measures should be applied. Pseudomebranous colitis has been reported with the use of cephalosporins (and other wide spectrum antibiotics); if diarrhea occurs, the drug should be discontinued promptly. Safety of cefuroxime administration in pregnant women has not been established. It is also not recommended for nursing mothers. Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins. Cefuroxime should not be used in children below the age of 3 months.

Adverse Reactions

Cefuroxime is generally well tolerated and local or systemic reactions listed below are the most common adverse effects which have been encountered rarely;

  • Local reactions: Thrombophlebitis has occurred with intravenous administration. Rash, urticaria and pruritus have been recorded.
  • Gastrointestinal reactions: Nausea, diarrhea and colitis. Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.
  • Hepatic reactions: Transient rise in SGOT, SGPT, alkaline phosphotase, LDH and biluribin levels has been noted.

Drug Interactions

There is no report on the interaction of cefuroxime with any other drug. A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict’s or Fehling’s solution or with Clinitest tablets), but not with enzyme-based tests for glycosuria. A false negative reaction may occur in the ferricyanide test for blood glucose.

Dosage and Administration

Multisef injection can be administered intramuscularly or intravenously.

  • Adults: The usual adult dosage is given every 8 hours for 5 or 10 days. Usually, in uncomplicated urinary tract infections, skin and soft tissue infections, disseminated gonococcal infections and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. This dose can be increased to 1.5 g in serious or severe infections. In bone and joint infections, a 1.5 g dose every 8 hours is recommended. In life threatening infections or infections due to less susceptible organisms, 1.5 g every 6 hours may be required.
  • For infants and children: Above 3 months of age, administration of 50-100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dose of 100 mg/kg/day not to exceed the maximum adult dose should be used for more severe and serious infections. In case of bone and joint infections, a dose of 150 mg/kg/day every 8 hours is recommended and the total daily dose should not exceed the maximum adult dose. In case of bacterial meningitis, 200-240 mg/kg/day intravenously in divided doses every 6-8 hours is recommended.

Multisef IM 750 mg vial for injection should be administered intramuscularly.

Preparation of Multisef Solution

Preparing Solution for Intramuscular Use

Each 250 mg vial of MULTISEF should be constituted with 1 mL of sterile water for injection. Each 750 mg vial of MULTISEF should be constituted with 3 mL of sterile water for injection. Shake gently to disperse and withdraw completely the resulting suspension for injection.

Multisef IM

Multisef 250 mg IM vial for injection 1mL is diluted with Multisef 750 mg IM vial for injection 3 mL diluent and shaken until an opaque suspension is obtained. All of the suspension is withdrawn into the injector and administered intramuscularly. Diluted suspensions are stable for 24 hours at room temperature and for 48 hours in the refrigerator.

Preparing Solution for Intravenous Use

Each 250 mg vial of MULTISEF should be constituted with 2 mL of sterile water for injection. Each 750 mg vial of MULTISEF should be constituted with 6 mL of sterile water for injection. Withdraw completely the resulting solution for injection. It can be administrated either directly in intravenous way or into the parenteral set.

Overdosage

In managing overdosage, the patient's airway should be protected and ventilation and perfusion supported. Patient's vital signs, blood gases and serum electrolytes should be meticulously monitored and maintained. If the patient develops convulsions, the drug should be promptly discontinued; anticonvulsant therapy may be administered if clinically indicated.

Storage Conditions

Should be kept out of reach of children, at room temperature (<25ºC) and in its package.

Available Forms

MULTISEF IM 250 mg vail containing powder for injection, 1 vial + 1 diluent ampoule (1 mL)

MULTISEF IM 750 mg vail containing powder for injection, 1 vial + 1 diluent ampoule (3 mL)

MULTISEF for injection 250 mg, 1 vial + 1 diluent ampoule (2 mL)

MULTISEF for injection 750 mg, 1 vial + 1 diluent ampoule (6 mL)

Name And Address Of The Authorisation Holder

Mustafa Nevzat Ilac Sanayii A.Ş. Prof. Dr. Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul.

Name And Address Of The Manufacturing Company

Mustafa Nevzat Ilac Sanayii A.Ş. ÇobançeşmeMah.Sanayi Cad. No.13 Yenibosna-Istanbul.

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