FLAMAZINE Cream (2019)
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Περιεχόμενα
Name of the medicinal product
FLAMAZINE CREAM 1.0% w/w.
Qualitative and quantitative composition
Contains Silver sulfadiazine 1% w/w. Excipients: Contains 4% cetyl alchol and 7% w/w propylene glycol. For the full list excipients, see section 6.1
Pharmaceutical form
Cream. White to off-white, oil in water, sterile homogeneous cream.
Therapeutic indications
FLAMAZINE cream is indicated for the prevention of infection in severe burns. Other types of wounds, such as pressure sores and leg ulcers, may also benefit from the application of FLAMAZINE cream.
Posology and method of administration
To be applied topically. Burns and Leg Ulcers/Pressure Sores: A layer approximately 3 to 5mm thick should be applied to the affected area using a sterile glove or spatula. The area should then be covered ...
Contraindications
As sulfonamides are known to cause kernicterus, FLAMAZINE cream should not be used at, or near term pregnancy, on premature infants or on newborn infants during the first months of life. FLAMAZINE cream ...
Special warnings and precautions for use
Transient leucopenia has occurred although its association with application of FLAMAZINE has not been confirmed. Nevertheless, regular blood counts are advisable in patients on long-term treatment. Patients ...
Interaction with other medicinal products and other forms of interaction
As silver may inactivate enzymatic debriding agents, their concomitant use may be inappropriate. In large-area burns where serum sulfadiazine levels may approach therapeutic levels, it should be noted ...
Fertility, pregnancy and lactation
Use in pregnancy – Pregnancy Category C Sulfonamides may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Sulfonamides should therefore be avoided ...
Effects on ability to drive and use machines
The effects of this medicine on a persons ability to drive and use machines were not assessed.
Undesirable effects
Blood & lymphatic Tissue Disorders Common: Leukopenia Leukopenia has been reported in 3-5% of burns patients treated with FLAMAZINE. This may be a drug related effect, and often manifests itself 2-3 days ...
Overdose
Not likely to occur with normal usage. In extensively burned patients or in patients suspected of showing symptoms of excessive absorption, it is important to optimally maintain fluid balance, not only ...
Pharmacodynamic properties
Silver sulfadiazine is a sulfonamide and has broad antimicrobial activity against both Gram-positive and Gram-negative organisms. Silver sulfadiazine acts on the cell membrane and cell wall. Unlike sulfadiazine ...
Pharmacokinetic properties
Absorption There is evidence that in large area wounds and/or after prolonged application, systemic absorption of silver can occur causing clinical argyria. The sulfadiazine readily diffuses across wounds ...
Preclinical safety data
Gentoxicity Silver sulfadiazine was not genotoxic in an in vitro bacterial mutation assay or an in vivo mouse micronucleus test (PO administration), although the doses administered were considered low. ...
List of excipients
Polysorbate 60 Polysorbate 80 Glycerol monostearate Cetyl alcohol Liquid paraffin Propylene glycol Purified water
Incompatibilities
None known.
Shelf life
24 months from the date of manufacture.
Special precautions for storage
FLAMAZINE should be stored below 25°C. Protect from light. The contents of one container are for the treatment of one person. 500g jars should be discarded 24 hours after opening. Tubes of FLAMAZINE should ...
Nature and contents of container
20g*, 50g or 80g* pre-printed cylindrical polyethylene tubes fitted with polypropylene caps. 250g* or 500g black polypropylene jar fitted with a black polyethylene or polypropylene lid. All tubes and jars ...
Special precautions for disposal and other handling
The contents of one container are for the treatment of one person.
Marketing authorization holder
Smith & Nephew Ltd, Unit A, 36 Hillside Road, Wairau Valley, Auckland 0627, New Zealand
Date of first authorization / renewal of the authorization
Date of publication in the New Zealand Gazette of consent to distribute the medicine: 29 October 2009
Date of revision of the text
28 June 2019
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