CAPREOMYCIN Powder for solution for injection (2015)
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Περιεχόμενα
Name of the medicinal product
CAPREOMYCIN Injection.
Qualitative and quantitative composition
Each vial contains Capreomycin Sulphate (approximately equivalent to 1g Capreomycin base).
Pharmaceutical form
Powder for solution for injection.
Therapeutic indications
Actions: Capreomycin is active against human strains of Mycobacterium tuberculosis. Frequent cross-resistance occurs between capreomycin and viomycin. Varying degrees of cross-resistance between capreomycin ...
Posology and method of administration
The usual dose is 1g daily (but 20mg/kg/day should not be exceeded) given by deep intramuscular injection only for 60 to 120 days, followed by 1g intramuscularly two or three times a week. Capreomycin ...
Contraindications
Hypersensitivity to the active substance.
Special warnings and precautions for use
Warnings The use of capreomycin in patients with renal insufficiency or pre-existing auditory impairment must be undertaken with great caution, and the risk of additional eighth cranial nerve impairment ...
Interaction with other medicinal products and other forms of interaction
Simultaneous administration of other antituberculous drugs which also have ototoxic and nephrotoxic potential (e.g. streptomycin, viomycin) is not recommended. Also, use with other drugs that are not given ...
Fertility, pregnancy and lactation
Pregnancy The safety of capreomycin for use during pregnancy has not been established. Capreomycin has been shown to be teratogenic in rats when given at 3.5 times the human dose. There are no adequate ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Renal: Elevation of serum creatinine or blood urea and abnormal urine sediment have been observed. Toxic nephritis was reported in one patient with tuberculosis and portal cirrhosis who was treated with ...
Overdose
Signs and symptoms Hypokalaemia, hypocalcaemia, hypomagnesaemia and an electrolyte disturbance resembling Bartters syndrome have been reported to occur in patients with capreomycin toxicity. Nephrotoxicity, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycobacterials ATC code: J04AB30 Capreomycin is active against human strains of Mycobacterium tuberculosis.
Pharmacokinetic properties
Capreomycin sulphate is not significantly absorbed from the gastrointestinal tract, and must be administered parenterally. Following intramuscular injection of 1g of capreomycin in human subjects, peak ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber in addition to those summarised in other sections of the Summary of Product Characteristics.
List of excipients
None.
Incompatibilities
Not applicable.
Shelf life
Shelf life: Three years. Reconstituted solutions of Capreomycin may be stored below 25°C for 24 hours. Discard unused portion.
Special precautions for storage
Store below 25°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Rubber stoppered, clear glass vial, with aluminium or plastic seal, containing capreomycin sulphate equivalent to approximately 1g capreomycin base, as sterile white powder.
Special precautions for disposal and other handling
The solution may acquire a pale straw colour and darken with time, but this is not associated with loss of potency or the development of toxicity. No special requirements for disposal. Any unused medicinal ...
Marketing authorization holder
King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland
Marketing authorization number(s)
PL 14385/0006
Date of first authorization / renewal of the authorization
Date of first authorisation:19 November 1997 Date of latest renewal: 01 June 2010
Date of revision of the text
19/11/2015
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