Regen-Ag cream, 10 mg/g, 50 g, Fiterman

Indications:
Regen Age is a medicine that belongs to the group of local chemotherapeutics.
Regen Age is used to prevent and treat infections in patients with burns and other skin lesions.

Composition:
The active substance is silver sulfadiazine. One gram of cream contains 10 mg of silver sulfadiazine.
The other ingredients are: macrogol 6-stearate, glycol stearate, macrogol 32-stearate, cetostearyl alcohol, liquid paraffin, macrogol cetostearyl ether 12, propylene glycol, methyl p-hydroxybenzoate (E218), n-propyl p-hydroxybenzoate (E216), purified water.

Method of administration:
- adults: it is recommended to apply a thin layer, in 4-6 applications per day, by gentle massage, of an amount of gel from the size of a cherry to that of a walnut (1-3 g), to the affected area; the therapeutic effect appears immediately after application and can last up to 6 hours;
- children over 2 years of age and adolescents: it is recommended to apply a maximum of 4 times a day, in the same way as for adults;
- children under 2 years of age: the gel is applied only on the recommendation of a pediatrician.
The duration of treatment depends on the therapeutic effect.

Contraindications:
Do not use Regen Ag
- if you are allergic (hypersensitive) to sulfonamides, silver sulfadiazine or any of the components of Regen Ag;
- in premature babies and newborns (aged 0-27 days), due to the possibility of kernicterus;
- if you are in the last trimester of pregnancy or if you are breast-feeding (see Pregnancy and breast-feeding).
Take special care when using Regen Ag
- if you have congenital glucose-6-phosphate dehydrogenase deficiency (since hemolysis may occur after applying the cream to large skin areas);
- if you have kidney or liver failure (as accumulation in the body may occur);
- if you have porphyria.
You should inform your doctor if you have these diseases, as well as if you have any chronic disease or metabolic disorder.
Similar to other topical antimicrobials, superinfections may occur after treatment with Regen Ag.
Avoid contact of the cream with the eyes.
In case of prolonged use of the cream on large areas of skin, your doctor should check your blood cell count, the concentration of sulfadiazine in your blood, your kidney function and perform a urine analysis (due to the possibility of crystalluria).

Precautions:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The effect of the following active substances or medicines may be influenced during concomitant treatment with Regen Ag:
- topical proteolytic enzymes: if Regen Ag is used concomitantly with topical proteolytic enzymes, silver may inactivate these topical proteolytic enzymes (enzymes that break down proteins);
- oral antidiabetics and phenytoin: their effect may be increased;
- if cimetidine is used concomitantly with Regen Ag, a decrease in the number of white blood cells may occur with a higher frequency.

Pregnancy, lactation and fertility:
Ask your doctor or pharmacist for advice before taking any medicine.
There are no studies available for silver sulfadiazine on use in pregnant women.
The drug should be prescribed with caution to pregnant women in the first two trimesters of pregnancy (if the burn is on an area greater than 20% of the body surface and if the therapeutic benefit to the patient outweighs the possible risk to the fetus).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

Driving and using machines:
No studies have been performed on the effects of Regen Ag on the ability to drive and use machines.

Presentation:
50g

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.