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SPC, UK: ZINACEF Powder for injection or infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zinacef for Injection or Infusion.

Qualitative and quantitative composition

Vials contain either 250 mg, 750mg or 1.5g cefuroxime (as sodium). The total quantity of sodium per vial is as follows: Zinacef strength Amount of sodium per vial 250 mg 14 mg 750 mg 42 mg 1.5 g 83 ...

Pharmaceutical form

Cefuroxime is a white to cream powder to which appropriate amounts of water are added to prepare an off-white suspension for intramuscular use or a yellowish solution for intravenous administration.

Therapeutic indications

Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1). Community acquired pneumonia. Acute exacerbations ...

Posology and method of administration

Posology Table 1. Adults and children ≥40 kg: Indication Dosage Community acquired pneumonia and acute exacerbations of chronic bronchitis 750 mg every 8 hours (intravenously or intramuscularly) Soft-tissue ...

Contraindications

Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic ...

Special warnings and precautions for use

Hypersensitivity reactions As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment ...

Interaction with other medicinal products and other forms of interaction

Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Cefuroxime is excreted by glomerular filtration and tubular secretion. ...

Fertility, pregnancy and lactation

Pregnancy There are limited amounts of data from the use of cefuroxime in pregnant women. Studies in animals have shown no reproductive toxicity (see section 5.3). Zinacef should be prescribed to pregnant ...

Effects on ability to drive and use machines

No studies on the effects of cefuroxime on the ability to drive and use machines have been performed. However, based on known adverse reactions, cefuroxime is unlikely to have an effect on the ability ...

Undesirable effects

The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm ...

Overdose

Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see ...

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, second-generation cephalosporins ATC code: J01DC02 Mechanism of action Cefuroxime inhibits bacterial cell wall synthesis following attachment ...

Pharmacokinetic properties

Absorption After intramuscular (IM) injection of cefuroxime to normal volunteers, the mean peak serum concentrations ranged from 27 to 35 µg/mL for a 750 mg dose and from 33 to 40 µg/mL for a 1000 mg dose, ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity ...

List of excipients

None.

Incompatibilities

Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions. The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore ...

Shelf life

Shelf life: Three years when stored below 25°C and protected from light.

Special precautions for storage

Store below 25°C and protect from light. After constitution, Zinacef should be stored at 2-8°C for no longer than 24 hours.

Nature and contents of container

Moulded glass (type 1 or III) vials with bromobutyl or fluoro-resin laminated butyl rubber plug, overseal and flip-off cap containing either 250mg, 750mg or 1.5g Zinacef. A bulk pack of 100 vials. Monovial ...

Special precautions for disposal and other handling

Instructions for constitution Table 4. Additional volumes and concentrations which may be useful when fractional doses are required:   Additional volumes and concentrations, which may be useful when ...

Marketing authorization holder

Glaxo Operations UK Limited, 980 Great West Road,Brentford,TW8 9GS Trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Marketing authorization number(s)

PL 00004/0263

Date of first authorization / renewal of the authorization

28 April 2002

Date of revision of the text

21<sup>st</sup> January 2019

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