Pharmacure Nozoil 10ml

Product Information

Drugs that are administered via the nose. such as allergy medication. often dry out the nasal mucosa in conjunction with repeated use. Nozoil restores the normal moisture to the nasal mucosa. Each vial of plerixafor is filled to deliver 1.2 ml of 20 mg/ml plerixafor aqueous solution for injection containing 24 mg of plerixafor.

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How does Flo Nozoil work?

In rat distribution studies concentrations of radiolabelled plerixafor was detected in reproductive organs (testes, ovaria, uterus) two weeks after single or 7 daily repeated doses in males and after 7 daily repeated doses in females. The elimination rate from tissues was slow. The efficacy and safety of Mozobil were evaluated in an open label, multi-center, controlled study in paediatric patients with solid tumors (including neuroblastoma, sarcoma, Ewing sarcoma) or lymphoma who were eligible for autologous hematopoietic stem cell transplantation (DFI12860). Patients with leukemia, persistent high percentage marrow involvement prior to mobilization, or previous stem cell transplantation were excluded. The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies (679 patients). Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea (n = 1) or hypoxia (n = 1). These events were generally mild or moderate and occurred within approximately 30 min after Mozobil administration.

Colds – during and after a cold or flu your nose may become sore due to crusting or excessive nose blowing.In the two placebo-controlled clinical studies of plerixafor, 24% of patients were ≥ 65 years old. No notable differences in the incidence of adverse reactions were observed in these elderly patients when compared with younger ones.

FLO Nozoil provides long lasting relief and it helps to shield a damaged nose from the drying effects of the air while helping to reduce the effects of inflammation. The dose of haematopoietic stem cells used for each transplant was determined by the investigator and all haematopoietic stem cells that were collected were not necessarily transplanted. For transplanted patients in the Phase III studies, median time to neutrophil engraftment (10-11 days), median time to platelet engraftment (18-20 days) and graft durability up to 12 months post-transplantation were similar across the Mozobil and placebo groups. Plerixafor is moderately bound to human plasma proteins up to 58%. The apparent volume of distribution of plerixafor in humans is 0.3 l/kg demonstrating that plerixafor is largely confined to, but not limited to, the extravascular fluid space. Pre-clinically, ipratropium bromide was found to be well-tolerated. Two-year carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to approximately 1,200 times the maximum recommended human daily dose for Rinaspray. Results of various mutagenicity tests were negative.Flo Nozoil is a preservative-free, non-medicated nasal moisturiser containing pharmaceutical-grade sesame seed oil (1mL/mL) to help relieve dry and crusting nasal tissue. The pharmacokinetics of plerixafor were evaluated in 48 paediatric patients (1 to less than 18 years) with solid tumours at subcutaneous doses of 0.16, 0.24 and 0.32 mg/kg with standard mobilisation (G-CSF plus or minus chemotherapy). Based on population pharmacokinetic modeling and similar to adults, µg/kg-based dosage results in increase in plerixafor exposure with increasing body weight in paediatric patients. At the same weight-based dosing regimen of 240 µg/kg, the plerixafor mean exposure (AUC 0-24h) is lower in paediatric patients aged 2 to <6 years (1410 ng.h/mL), 6 to <12 years (2318 ng.h/mL), and 12 to <18 years (2981 ng.h/mL) than in adults (4337 ng.h/mL). Based on population pharmacokinetic modeling, the plerixafor mean exposures (AUC 0-24h) in paediatric patients aged 2 to <6 years (1905 ng.h/mL), 6 to <12 years (3063 ng.h/mL), and 12 to <18 years (4015 ng.h/mL), at the dose of 320 µg/kg are closer to the exposure in adults receiving 240 µg/kg. Age over 60 and/ or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as predictors of poor mobilisation.

The adverse reactions reported in patients with lymphoma and multiple myeloma who received Mozobil in the controlled Phase III studies and uncontrolled studies, including a Phase II study of Mozobil as monotherapy for haematopoietic stem cell mobilisation, are similar. No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age, or gender. Studies to investigate the possible influence of ipratropium bromide on fertility, embryo-fetotoxicity, and peri-/postnatal development have been performed on mice, rats and rabbits. High oral dose levels, i.e. 1000 mg/kg/day in the rat and 125 mg/kg/day in the rabbit were maternotoxic for both species and embryo-/fetotoxic in the rat, where the fetal weight was reduced. Treatment-related malformations were not observed. The highest, technically feasible doses for inhalation of the metered dose aerosol, 1.5 mg/kg/day in rats (human equivalent dose (HED) of 0.24 mg/kg) and 1.8 mg/kg/day in rabbits (HED of 0.576 mg/kg), showed no adverse effects on reproduction.the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction Plerixafor has to be drawn up into a syringe size type which should be selected according to the weight of the patient.