The instruction for medical use
the Trade name
contains the International unlicensed name Sulfadiazinum Dosage Form 1% Cream Structure of 1 G of Cream:
active agent: Sulfadiazinum of silver of 10 mg
excipients: cetyl alcohol, the peanut butter hydrogenated, polysorbate 60, propylene glycol, methylparahydroxybenzoate, propilparagidroksibenzoat, the water purified.
White homogeneous cream.
Antimicrobial drugs for topical administration. Streptocides. Sulfadiazinum.
The ATX D06BA01 code
Pharmacokinetics Sulfadiazinum properties of silver can undergo absorption only in case of its use in large numbers, on extensive sites of skin and during the long span.
At the patients with serious burn wounds undergoing treatment by silver Sulfadiazinum after putting cream on burns within 24 hours the concentration of Sulfadiazinum in a syvorotoka reached 9 mg/dl.
The risk of emergence of an argiriya at the increased system absorption of silver is minimum.
At the patients with burn wounds undergoing treatment by silver Sulfadiazinum, silver kumulirutsya in various fabrics.
About 60% of Sulfadiazinum are removed in not changed view with urine. The amount of Sulfadiazinum in urine is proportional to the area affected with a burn and to amount of the applied cream. Sulfadiazinum can kumulirovatsya at patients with serious violations of function of kidneys, in particular, in organism dehydration.
Elimination half-life makes 10 hours. At the patients suffering from an anury, elimination half-life increases and makes till 22 o’clock.
Dermasinum is local chemotherapeutic means for prevention and treatment of burn infections.
When drawing breaks up to the burn surface, Sulfadiazinum of silver, at the same time slowly and continuously releasing ions of silver and streptocide. These ions contact deoxyribonucleic acid, inhibiting these growth and reproduction of bacterial cells, not affecting at the same time cells of tissues of skin and hypodermic cellulose. Dermasinum cream has the wide range of antibacterial activity including actually all species of the microbes causing infection of burn and other wounds on the surface of skin.
The table of the minimum overwhelming concentration (MOC) of Sulfadiazinum of silver (in-vitro) to sensitive microorganisms:
of MPK (mkg/ml)
of Pseudomonas aeruginosa 50 or less Pseudomonas maltophilia 50 or less Enterobacter 100 or less E.
cloacae 50 or less Klebsiella 100 or less E.
coli 50 or less Serratia 100 or less Proteus 50 or less Morganella morganii 50 or less Providencia 50 or less Citrobacter 50 or less Acinetobacter 100 or less Corynebacterium diphteriae 50 or less Staphylococcus 100 or less Streptococcus pyogenes 50 or less Enterococcus spp 100 or less Clostridium perfrigens 100 or less Candida albicans 100 or less Herpes 10 Dermatophytes 100 Herella 6.25 Aspergillus fumigatus 100 Aspergilus flavus 100 Mucor pussilus 50 Rhizopus nigricans 10
Dermasinum gets into nekrotizirovanny fabrics and exudate. This action is especially important because system antibiotics are not effective against bacterial flora of avascular burn necrosis.
– treatment and prevention of burn infections, including to an autodermoplastika
– treatment and prevention of infection of decubituses, trophic ulcers, various wounds, grazes, the replaced sites of skin
the Route of administration and doses
Outwardly. Dermasinum cream is intended only for drawing on skin.
Cream can be used using bandages (cream is applied on a sterile gauze, then is imposed on a burn wound) or without bandage. Cream can also be applied with use of a sterile shovel or in sterile gloves.
Before use of cream it is necessary to clean and process completely burned site of skin.
Cream should be applied with a thin layer in 2-4 mm once a day, in case of heavy burn wounds, cream can be applied several times in day, however anyway cream should be applied repeatedly at least each 24 hours. Before each repeated drawing, the wound should be washed with water or special antiseptic solution for the purpose of removal of residues of cream or discharges which are emitted plentifully after putting cream Dermasinum. Discharges on color are similar to pus, but in fact are aseptic.
The route of administration of cream is identical to treatment of burns and trophic ulcers.
Bandages should be changed at each use.
Dermasinum the cream packaged in tubas is intended for reuse, but only one patient.
Drug does not leave spots on clothes and on bed linen.
Duration of treatment is determined by the doctor.
Use for children
the Recommended dosage at babies is more senior than two months and at children does not differ from that at adults. A route of administration at children same, as at adults.
Often (≥1/100 – & lt, 1/10)
– a leukopenia *, generally decrease in neutrophils
– irritation of skin, an itching, burning sensation, pain when imposing, the skin rash, gray coloring of skin (argiriya)
Very seldom (≥1/10000)
– skin and allergic reactions, including Stephens-Johnson’s syndrome and a Lyell’s disease
– a hyperpegmentation
At prolonged use on big wound surfaces system side effects are possible:
– an eosinophilic leukocytosis
– liver necrosis
– interstitial nephrite
– a crystalluria
*-Tranzitornaya a leukopenia usually does not demand suspension of treatment or acceptance of other special measures. Patients are recommended to carry out blood test.
– hypersensitivity to sulfanamide drugs or any of drug components
– the pregnancy period, the lactation period
– premature newborns and also children within the first 2 months after the birth
– the porphyria
Sulfadiazinum of silver can inactivate the local proteolytic fermental drugs used for clarification of a wound at their simultaneous use.
Can strengthen effect of anticoagulants, oral hypoglycemic drugs from group of sulphonylurea, a methotrexate, sodium thiopental.
It is noted that simultaneous use of Cimetidinum can increase the frequency of development of a leukopenia.
the care when assigning Is necessary for patients with the known hypersensitivity to sulfanamide drugs because of possible development of cross sensitivity.
As well as at use of other local antimicrobial drugs, at treatment by Sulfadiazinum superinfection can develop.
It is required to be careful at treatment of patients with congenital insufficiency glyukozo-6-fosfatdegidrogenazy because of risk of development of hemolysis.
The care is necessary when assigning for patients with disturbances of functions of a liver and kidneys because of possible cumulation of drug owing to the slowed-down removal. It is necessary to resolve an issue of expediency of continuation of therapy, considering possible consequences of its cancellation and advantage at its continuation. It is regularly necessary to carry out control of content of Sulfadiazinum in blood serum.
When putting cream Dermasinum on burn wounds of the big area the concentration of Sulfadiazinum in blood serum can reach therapeutic level at oral administration. In this case control of concentration of Sulfadiazinum in blood serum and also control of urine on possible presence of Sulfadiazinum is necessary.
Drug should not be used at a porphyria.
To avoid hit in eyes.
Important information of rather some excipients
Ointment contains methylparahydroxybenzoate and propilparagidroksibenzoat which can cause allergic reactions (on the slowed-down type). Drug contains the peanut hydrogenated butter therefore, in the presence of an allergy to a peanut or to soy, it is recommended not to use drug. Drug contains propylene glycol which can cause irritation of skin. Drug also contains cetyl alcohol which can cause local skin reactions (for example, contact dermatitis).
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to run the vehicle or potentially dangerous mechanisms.
At prolonged use on the extensive areas of a body of concentration of streptocide in blood serum can approach the level reached at system use that can lead to development of the side reactions characteristic of streptocides.
Is recommended to define concentration of Sulfadiazinum in blood serum. If necessary it is necessary to control function of kidneys and number of uniform elements of blood.
Symptomatic treatment, plentiful drink is appointed (it is recommended to support a daily urine at the level of 1200 – 1500 ml and more). Rezorbirovanny Sulfadiazinum is easily dialyzed by means of haemo – and peritoneal dialysis.
A form of release and packing
On 50 g of cream in tubas aluminum. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not higher than 25 wasps.
To store out of children’s reach!
not to use a period of storage after the expiry date specified on packing.
According to the prescription
of Producer/Upakovshchik Salyutas Pharm GmbH, Germany
Lange Göhren 3, 39171 Osterweddingen, Germany
the Owner of the registration certificate
Lek Pharmasyyutikals of of, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Sandoz Pharmasyyutikals d. d. in the Republic of KazahstanRespublika Kazakhstan, 050051, Almaty, Luganskogo St., 96, Business center “Keruyen”, the 3rd floor. Ph. +7 (727) 2581048 Fax: +7 (727) 2581047
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