LINCOCIN Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
LINCOCIN lincomycin 600mg/2mL (as hydrochloride) injection vial.
Qualitative and quantitative composition
Lincomycin hydrochloride. Each mL contains lincomycin hydrochloride equivalent to lincomycin base 300 mg; Excipients with known effect: benzyl alcohol, 9.45 mg For the full list of excipients, see section ...
Pharmaceutical form
LINCOCIN Injection is a clear, colourless or almost colourless solution, practically free from particles.
Therapeutic indications
LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of gram-positive aerobes such as streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic ...
Posology and method of administration
Note: If significant diarrhoea occurs during therapy, this antibiotic should be discontinued (see section 4.4, Special Warnings and Precautions for Use). LINCOCIN is incompatible with novobiocin, kanamycin ...
Contraindications
This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin. It is not indicated in the treatment of minor bacterial infections or viral infections. Lincomycin ...
Special warnings and precautions for use
Lincomycin should not be injected IV as a bolus but should be infused as described in the DOSAGE AND ADMINISTRATION section. Risk of Colitis The use of lincomycin can lead to the development of severe ...
Interaction with other medicinal products and other forms of interaction
LINCOCIN has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such ...
Pregnancy and lactation
Effects on fertility No data available. Use in pregnancy Category A. In humans, lincomycin crosses the placenta and results in cord serum levels about 25% of the maternal serum levels. No significant accumulation ...
Effects on ability to drive and use machines
No studies were conducted to determine the effect of LINCOCIN on ability to drive and use machines.
Undesirable effects
Adverse reactions are listed according to the following categories: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 to <1/100, Rare: ≥1/10,000 to <1/1,000, Very rare: <1/10,000, Not known: ...
Overdose
The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis ...
Pharmacodynamic properties
Mode of action LINCOCIN is an antibiotic produced by fermentation of Streptomyces lincolnensis. LINCOCIN inhibits bacterial protein synthesis by binding to the 50S subunit of the bacterial ribosome. LINCOCIN ...
Pharmacokinetic properties
Absorption LINCOCIN is absorbed rapidly after a 500 mg oral dose in the fasting state, producing an average peak serum level of 5.3 micrograms/mL at 2 hours post dose. Doubling the dose increases but does ...
Preclinical safety data
Genotoxicity Lincomycin was not genotoxic in various in vitro and in vivo genotoxicity studies including bacterial reverse mutation assays, gene mutation assays in mammalian cells and Drosophila melanogaster ...
List of excipients
Benzyl alcohol Water for injections, q.s.
Incompatibilities
LINCOCIN is incompatible with novobiocin, kanamycin and phenytoin.
Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Special precautions for storage
Store below 25oC. Protect from light. Do not freeze.
Nature and contents of container
LINCOCIN Injection is available as 5 2 mL vials.
Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
Marketing authorization holder
Pfizer Australia Pty Ltd, 38-42 Wharf Road, West Ryde NSW 2114, Toll Free Number: 1800 675 229, www.pfizer.com.au
Date of first authorization / renewal of the authorization
2 August 1991
Date of revision of the text
13 September 2018
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