Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 5.27 mg/ml (equivalent: bupivacaine hydrochloride, qty 5 mg/ml); adrenaline (epinephrine) acid tartrate, quantity: 9.1 microgram/ml (equivalent: adrenaline (epinephrine), qty 5 microgram/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium metabisulfite; citric acid; sodium citrate - pfizer bupivacaine with adrenaline injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows;,surgical anaesthesia:,- epidural block for surgery,- field block (minor and major nerve blocks and infiltration),analgesia,- continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,- field block (minor nerve block and infiltration),the choice of 2 strengths, 0.25%, and 0.5% makes it possible to vary the degree of motor blockade.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 2.64 mg/ml (equivalent: bupivacaine hydrochloride, qty 2.5 mg/ml); adrenaline (epinephrine) acid tartrate, quantity: 4.5 microgram/ml (equivalent: adrenaline (epinephrine), qty 2.5 microgram/ml) - injection, solution - excipient ingredients: sodium citrate; citric acid; sodium metabisulfite; water for injections; sodium chloride - pfizer bupivacaine with adrenaline is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows;,surgical anaesthesia:,- epidural block for surgery,- field block (minor and major nerve blocks and infiltration),analgesia,- continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,- field block (minor nerve block and infiltration),the choice of 2 strengths, 0.25%, and 0.5% makes it possible to vary the degree of motor blockade.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - sirolimus - coated tablets - sirolimus 1 mg - sirolimus - rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. it is recommended that rapamune be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. rapamune may be continued as maintenance therapy with corticosteroids only if cyclosporine can be progressively discontinued.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed ditromethamine - carcinoma, non-small-cell lung; mesothelioma - folic acid analogues, antimetabolites - malignant pleural mesotheliomapemetrexed hospira uk limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed hospira uk limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daptomycin, quantity: 350 mg - inhalation, powder for - excipient ingredients: sodium hydroxide; citric acid - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: citric acid; sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.