the package insert of the medicine Silkis. Active principles Calcitriol. Sale under medical prescription.
topical Treatment of psoriasis vulgaris.
Hypersensitivity to calcitriol or to the other components of the formula. Patients with hypercalcemia or with alteration of the metabolism of calcium. Patients with renal or hepatic dysfunction.
How to use?
Exclusively for external use.
Wash and dry the affected area. apply a thin layer of silkis ointment on the areas affected with psoriasis twice a day, once in the morning and once at night, before bedtime.
The product should not be applied on the face. avoid accidental contact of product with eyes and lips. the product should not be used under occlusion.
The maximum recommended dose is 30 g of ointment per day, up to 35% of the body surface.
After the application, wash your hands thoroughly. keep the product out of the reach of children.
Conduct in overdose: excessive use will not lead to therapeutic results faster or better, and may occur irritation of the skin, with designed, peeling, and discomfort.
The application of excessive (more than 30g per day) may produce elevation of calcium levels in the plasma and in the urine. in these cases, you should discontinue the treatment until the levels of calcium in serum and urine return to normal value.
elderly Patients: patients over 65 years should use the product under medical supervision.
Attention: this product is a new drug and although research carried out have indicated the efficacy and safety when properly indicated, can occur adverse reactions unpredictable, not yet described or known. in the case of suspected adverse reactions the physician should be notified.
What are the evils that can cause me?
it Can occur irritation transient skin, which disappears with the decrease of the frequency of application or discontinuation of treatment.
Warnings and Precautions
what should I know before using?
If you experience local irritation intense, reduce the frequency of application and consult the doctor.
Pregnancy : The safety and efficacy of SILKIS during human gestation has not been established, although studies in animals have not shown evidence of toxicity. Its use during pregnancy should be decided by the doctor.
Lactation: After oral administration, calcitriol is excreted through breast milk. For this reason it is not recommended to use the product during breastfeeding.
paediatric Use has not been established safety and efficacy in children.
Due to its mild irritating potential, it is possible that concomitant use with abrasive substances, astringents or irritants may produce irritant effects.
Use with caution in patients under treatment with medications that increase the level of serum calcium, such as diuretics (thiazides, or patients receiving calcium supplements or high doses of vitamin D.
there are No studies on the concomitant use of calcitriol and other medications for the treatment of psoriasis over the same area of the skin.
The absorption of calcitriol through human skin is low, not being likely to occur in the interaction with medications systemic.
Sale under medical prescription.
SILKIS is intended for the topical treatment of psoriasis vulgaris. The lesions of the skin improve gradually with the course of treatment.
The product should be kept at room temperature, not exceeding 25ºC.
The validity period is 24 months from the date of manufacture is written on the packaging. Do not use medicines with expired.
Tell your doctor the occurrence of pregnancy during treatment or after its completion. Tell your doctor if you are breast-feeding. The use of the product during pregnancy should be evaluated by the doctor. It is not recommended to use the product during breastfeeding.
EXCLUSIVELY FOR USE TOPIC.
In case of contact with eyes, rinse immediately with plenty of water. Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment. Do not stop treatment without the knowledge of your doctor.
Tell your doctor the appearance of reactions unpleasant. Discontinue use if you experience reactions hipersensiblidade.
ALL MEDICINE SHOULD BE KEPT OUT OF the REACH OF CHILDREN.
Tell your doctor about any medicine you are using before the beginning or during the treatment.
do NOT USE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR. IT CAN BE DANGEROUS TO YOUR HEALTH.
– TECHNICAL INFORMATION
Calcitriol is a derivative of Vitamin D, which inhibits the proliferation and stimulates the differentiation of keratinocytes. Calcitriol inhibits proliferation of T-cells and normalises the production of various causative factors of the inflammation. The administration is topical in patients with plaques of psoriasis result in improvement of the skin lesions. This effect is noticed in 2 or 4 weeks after the start of treatment.
Studies in animals and humans have not demonstrated the potential fototóxico or fotoalérgico for calcitriol.
– the PHARMACOKINETIC PROPERTIES
After topical application of the ointment on the skin, occurs absorption incomplete calcitriol, and it is unknown if the exact degree of absorption. After absorption, calcitriol and its metabolites were detected in plasma. The effect of the metabolites on the homeostasis of calcium is insignificant. In the majority of patients, the circulating levels of calcitriol, exogenous are below the level of detection (2 pg/ml). In clinical trials, there was a significant increase in plasma levels of calcitriol after the treatment of large areas of body surface up to 6000 cm2 (35% of body surface area).
Galderma Brasil Ltda.
Rodovia SP-101, Km 9, Condominium, Tech Town, 13186-904 – Hortolândia – SP – Brazil. CNPJ 00.317.372/0004-99
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