Pharmacure Nozoil 10ml
- Brand: Unbranded
Description
For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be used. This type of syringe has major graduations for 0.1 ml and minor graduations for 0.01 ml and therefore is suitable to administer plerixafor, at a dose of 240 µg/kg, to paediatric patients of at least9 kg body weight. Ipratropium is a quaternary amine that is rapidly absorbed from the nasal mucosa, however to a low extent. In healthy volunteers approximately 10% of a nasally given dose was excreted unchanged in the urine over 24 hours. In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain. Flo Nozoil helps relieve dry and crusting nasal tissue. Your healthcare practitioner may recommend Nozoil in the following situations: 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.
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S8 PRESCRIPTION
Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in approximately 30-60 minutes (t max). Following subcutaneous administration of a 0.24 mg/kg dose to patients after receiving 4-days of G-CSF pre-treatment, the maximal plasma concentration (C max) and systemic exposure (AUC 0-24) of plerixafor were 887 ± 217 ng/ml and 4337 ± 922 ng·hr/ml, respectively. In the two Phase III studies in non-Hodgkin's lymphoma and multiple myeloma patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 μg/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis. Adverse reactions that occurred more frequently with Mozobil and G-CSF than placebo and G-CSF and were reported as related in ≥1% of the patients who received Mozobil, during haematopoietic stem cell mobilisation and apheresis and prior to chemotherapy/ablative treatment in preparation for transplantation are shown in Table 1.
Adults: 1-2 squirts per nostril 2-3 times daily as required. Children from 4 to 12 years: 1 squirt per nostril twice daily as required. Adverse reactions are listed by System Organ Class and frequency. Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Flo Nozoil is not recommended for children under 4 years of age, unless advised by a healthcare practitioner. Precautions
Thirty patients were treated with 0.24 mg/kg of Mozobil in an open label, multicenter, controlled study (DFI 12860) (see section 5.1).
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. In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ cells was observed from 6 to 9 hours after administration. In pharmacodynamic studies in healthy volunteers of plerixafor in conjunction with G-CSF administered at identical dose regimen to that in studies in patients, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 18 hours after plerixafor administration with peak response between 10 and 14 hours. 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. Immediate hypersensitivity reactions following the use of Rinaspray have been demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.SDF-1α and CXCR4 play major roles in embryo-foetal development. Plerixafor has been shown to cause increased resorptions, decreased foetal weights, retarded skeletal development and increased foetal abnormalities in rats and rabbits. Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4. Systemic exposure at No Observed Adverse Effect Level for teratogenic effects in rats and rabbits was of the same magnitude or lower as found at therapeutic doses in patients. This teratogenic potential is likely due to its pharmacodynamic mechanism of action. Adults: 2-4 drops per nostril 2-3 times daily as required. Children from 4 to 12 years: 1-2 drops per nostril twice daily as required. Based on increasing exposure with increasing body weight the dose should not exceed 27 mg/day if the creatinine clearance is lower than 50 ml/min. Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies (242 patients). Patients were primarily treated with daily doses of 0.24 mg/kg plerixafor by subcutaneous injection. The exposure to plerixafor in these studies ranged from 1 to 7 consecutive days (median = 2 days). Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
- Fruugo ID: 258392218-563234582
- EAN: 764486781913
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