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Pharmacure Nozoil 10ml

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About this deal

In pivotal clinical studies supporting the use of Mozobil, all patients received daily morning doses of 10 μg/kg G-CSF for 4 consecutive days prior to the first dose of plerixafor and on each morning prior to apheresis. In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions (orthostatic hypotension and/or syncope) following subcutaneous administration of plerixafor doses ≤0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil administration. 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.

Exposure margins in the juvenile rat study at the maximum tolerated dose (MTD) were ≥18 fold when compared with the highest clinical paediatric dose in children up to 18 years of age. 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.

Warnings

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. Increasing age is another reason for dry mucosa. Women frequently experience this after the menopause. Spending time in dry, particle-rich environments exacerbates the problem. 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.

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. An in vitro general receptor activity screen showed that plerixafor, at a concentration (5 µg/ml) several fold higher than the maximum human systemic level, has moderate or strong binding affinity for a number of different receptors predominantly located on pre-synaptic nerve endings in the central nervous system (CNS) and/or the peripheral nervous system (PNS) (N-type calcium channel, potassium channel SK CA, histamine H 3, acetylcholine muscarinic M 1 and M 2, adrenergic α1 B and α2 C, neuropeptide Y/Y 1 and glutamate NMDA polyamine receptors). The clinical relevance of these findings is not known. When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and subsequently collected in the leukapheresis product. Results showed that, in case tumour cells are mobilised, the number of tumour cells mobilised is not increased upon Mozobil plus G-CSF compared to G-CSF alone. Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections (see section 4.8). Appropriate precautions should be taken because of the potential for these reactions.

S8 PRESCRIPTION

As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, Rinaspray, as with other anticholinergics, should be used with caution in these patients. the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction Nasal CPAP and oxygen therapy - nasal CPAP and oxygen therapy may cause nasal dryness or congestion. Flo Nozoil has been clinically trialled in CPAP therapy and shown to help alleviate nasal dryness and improve the comfort of CPAP treatment. People who suffer from nosebleeds often develop dry crusts in the nose. They chafe and irritate and cause new nosebleeds. The pharmacokinetics of plerixafor have been evaluated in lymphoma and multiple myeloma patients at the clinical dose level of 0.24 mg/kg following pre-treatment with G-CSF (10 μg/kg once daily for 4 consecutive days).

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