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Розель 60 мг для инъекций | Розель 60 мг таблетки | Apple фармацевтика

Розель 60 мг для инъекций | Розель 60 мг таблетки | деносумаб 
 Apple, фармацевтика




Rozel 60 мг  относится к новому полностью человеческому моноклональному антителу IgG2, особенно к рецепторному активатору лиганда каппа-B ядерного фактора (RANKL), ограничивает маркеры резорбции кости у пациентов с различием метастатических опухолей и изучается в многочисленных клинических испытаниях на предмет ингибирования и лечение костных метастазов. Химически, он существует из 2 тяжелых и 2 легких цепей. Каждая легкая цепь содержит 215 аминокислот. Каждая тяжелая цепь содержит 448 аминокислот с 4 внутримолекулярными дисульфидами.


ПРЕДПИСАНО ДЛЯ


Лечение пациентов с постменопаузой у женщин с остеопорозом с высоким риском перелома. 
Лечение пациентов с увеличением костной массы у мужчин с повышенным риском переломов, получающих терапию андрогенной депривации при неметастатическом раке предстательной железы. 
Treatment for patients having to increase bone mass in women at more risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

DOSAGE


For adult :
Osteoporosis :
60mg SC (subcutaneously) once every 6 months
Injection of drug should be done in upper arm, upper thigh or abdomen
Giant Cell Tumor of bone :
120mg SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
Injection of drug should be done in upper arm, upper thigh or abdomen
Osteolytic Bone Metastases of Solid Tumors :
120mg subcutaneously every 4 weeks
Injection of drug should be done in upper arm, upper thigh or abdomen
Hypercalcemia :
120mg subcutaneously every 4 weeks
Injection of drug should be done in upper arm, upper thigh or abdomen
Dosage and administration in pediatric :
13 years and older and 45kg or more
Giant Cell Tumor of bone:
Dose of 120mg Rozel tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
OVERDOSE: 
Rozel overdose has no overdose. If occurs seek to emergency department and call poison control

MECHANISM

Denosumab linked to RANKL, a protein which is specific for the formation, function and survival of osteoclasts, the cells necessary for bone resorption. Denosumab prohibits osteoclast formation, function and survival hence, reducing bone resorption and raising bone mass and strength of the bone.


ADME

Peak plasma concentration: 6.75mcg/mL
Tmax : 10days
Without aggregation in Rozel pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months. Pharmacokinetics of Rozel will not affected by the binding antibodies formation.
Half-life is 25.4 days.


PRECAUTION

• Before to start treatment with Rozel, discuss with the doctor about any other regimens you are using (including over-the-counter drugs, vitamins, or herbal remedies). Avoid having aspirin or products containing aspirin unless your doctor permits this. 
• Rozel injection may improve the negative effects of immuno-suppressants. Especially the risk for serious infections may be increased. Inform your doctor of any immuno-suppressive drugs you early consume. 
• Not to receive any type of vaccination without your doctor's consultation while admonishing 
denosumab
• Use in pregnancy only if benefit to mother outweighs risk to fetus. Consult with doctor before the treatment 
• During Rozel treatment do not breastfeed your infants.


DRUG INTERACTION


No formal drug-drug interaction with denosumab during trials.
When interacting with some anticancer drug, orthopedic drugs, vaccines will lead to risk of adverse effects can be increased


CONTRAINDICATION

Rozel is contraindicated in patients having Hypocalcemia, Pregnancy, Hypersensitivity


LACTATION

Rozel 60mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Rozel 60mg injection, a decision should be considered that to discontinue nursing or discontinue the drug by giving preference of the importance of the drug to the mother.


STORAGE

Store at 2℃ to 8℃ in the original container, avoid freeze
Before to administration keep at room temperature
Rozel protect from direct light and heat.


MISSED DOSE

Принимайте дозу непосредственно перед продолжением приема следующей дозы, затем пропустите пропущенную дозу и продолжайте регулярное расписание. Избегайте приема двойной дозы одновременно. Пожалуйста, проконсультируйтесь с врачом для получения дополнительной информации.


ПОБОЧНЫЕ ЭФФЕКТЫ


Общие побочные эффекты:  усталость, мышечная слабость, снижение уровня фосфора в крови, тошнота
Менее распространенные побочные эффекты:
Одышка, гипокальциемия, кашель, артралгия, боль в конечностях, экзема, головная боль

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