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ROCEPHIN® |
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Product Information (Abridged) |
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Properties |
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ROCEPHIN® (Ceftriaxone) is a potent semi
synthetic |
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once daily administered third generation cephalosporin |
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with a broad antibacterial spectrum for intramuscular |
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and intravenous use. Cefriaxone is characterized by an |
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unusually long elimination half life of approximately |
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eight (8) hours and is reversibly bound to albumin, with |
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the binding decreasing as concentration increases. 50 – |
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60% of ceftriaxone is excreted unchanged in the urine, |
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while 40 – 50% is excreted unchanged in the bile. |
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Ceftriaxone is not metabolized
systemically, but is converted to inactive metabolites
by the gut flora. |
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Microbiology |
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ROCEPHIN® is a broad
spectrum antibiotic active against the most common
aerobic gram-negative and gram postive pathogens.
Studies have shown ROCEPHIN® to have the
following main properties in vitro: |
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Unusually potent activity against H. influenzae, N.
meningitides, N.gonorrhoae and P.mirabilis. |
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Remarkable efficacy against Serratia marcescens,
Salmonella typhi and paratyphi, Streptococcus pneumoniae
and also Staphylococus aureus provided it is methicillin
susceptible. |
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Synergism with aminoglycosides, for example against Ps.
aeruginosa. |
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Bactericidal effect often at the minimium inhibitory
concentration owing to a strong affinity for the
penicillin-binding proteins. |
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High b-lactamase stability |
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Indications |
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Sepsis, meningitis, abdominal
infections, infections of the bones, joints, soft
tissue, skin and of wounds, infections in patients with
impaired defence mechanisms, renal and urinary tract
infections, respiratory tract infections, particularly
pneumonia and ear, nose and throat infections, genital
infections including gonorrhoea. Perioperative
prophylaxis of infections. |
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Dosage |
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Adults and children over 12 years: 1
– 2 g once daily. Neonates, infants and children up to
12 years: daily dose of 20 – 80 mg/kg body weight, not
to exceed 50mg /kg for neonates. Intravenous doses of
50mg or more per kg should be given by infusion over at
least 30 minutes.
Gonorrhoea: single i.m. dose of 250mg ROCEPHIN®
is recommended. |
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Contraindications |
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Known hypersensitivity to cephalosporins. |
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Precautions |
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Pregnancy (particularly in the first
trimester) unless absolutely necessary. Hypersensitivity
to penicillin (possibly of allergic cross-reactions).
Anaphylactic shock. |
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Side
effects |
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Gastrointestinal complaints, haematological changes,
skin reaction. |
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Packs |
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Packs of 250mg, 500mg and 1g. The
solvent ampoule for i.m. injections contains 1%
lidocaine solution. Water for injection should be used
as diluents for intravenous administration. |
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