United States - English - NLM (National Library of Medicine)

proficient rx lp - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association's diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual dur

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

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; peg-40 hydrogenated castor oil; purified water; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - posaconazole is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole is also indicated for the: ? treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. ? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Singapore - English - HSA (Health Sciences Authority)

pharmeng technology pte. ltd. - a/vietnam/1203/2004 (h5n1) - injection, suspension - 7.5µg haemagglutinin per 0.5ml - a/vietnam/1203/2004 (h5n1) 7.5µg haemagglutinin per 0.5ml

Singapore - English - HSA (Health Sciences Authority)

opella healthcare singapore pte. ltd. - fexofenadine 28 mg/5 ml eqv fexofenadine hydrochloride - suspension - 30.00 mg/5 ml - fexofenadine 28 mg/5 ml eqv fexofenadine hydrochloride 30.00 mg/5 ml

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: polysorbate 80; aluminium; histidine; sodium chloride; borax; water for injections - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: sodium chloride; histidine; borax; aluminium; water for injections; polysorbate 80 - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

Philippines - English - FDA (Food And Drug Administration)

drugmaker's laboratories, inc. - paracetamol - suspension - 125mg/5ml

United States - English - NLM (National Library of Medicine)

pharmacyclics llc - ibrutinib (unii: 1x70osd4vx) (ibrutinib - unii:1x70osd4vx) - ibrutinib 70 mg - imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll). imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll) with 17p deletion. imbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm). imbruvica is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy. none risk summary imbruvica can cause fetal harm based on findings from animal studies. there are no available data on imbruvica use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in animal reproduction studies, administration of ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 3-20 times the clinical dose of 420 mg daily produced embryofetal toxicity including structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data ibrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 10, 40 and 80 mg/kg/day. ibrutinib at a dose of 80 mg/kg/day was associated with visceral malformations (heart and major vessels) and increased resorptions and post-implantation loss. the dose of 80 mg/kg/day in rats is approximately 20 times the exposure in patients with cll/sll or wm administered a dose of 420 mg daily. ibrutinib at doses of 40 mg/kg/day or greater was associated with decreased fetal weights. the dose of 40 mg/kg/day in rats is approximately 8 times the exposure (auc) in patients administered a dose of 420 mg daily. ibrutinib was also administered orally to pregnant rabbits during the period of organogenesis at doses of 5, 15, and 45 mg/kg/day. ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal variations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased resorptions and post-implantation loss. the dose of 15 mg/kg/day in rabbits is approximately 2.8 times the exposure in patients with cll/sll or wm administered a dose of  420 mg daily. risk summary there is no information regarding the presence of ibrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with imbruvica and for 1 week after the last dose. imbruvica can cause fetal harm when administered to pregnant women [see use in specific populations ( 8.1 )] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating imbruvica. contraception females advise females of reproductive potential to use effective contraception during treatment with imbruvica and for 1 month after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with imbruvica and for 1 month following the last dose. chronic gvhd the safety and effectiveness of imbruvica have been established for treatment of cgvhd after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older. use of imbruvica for this indication is supported by evidence from imagine, a study which included pediatric patients age 1 year and older with previously treated cgvhd, including patients in the following age groups: one patient 1 year to less than 2 years of age, 20 patients 2 years to less than 12 years of age, and 19 patients 12 years to less than 17 years of age. additional supportive efficacy data was provided from study 1129 in adults [see adverse reactions ( 6.1 ), clinical pharmacology ( 12.3 ), and clinical studies ( 14.3 )] . the recommended dosage of imbruvica in patients age 12 years and older is the same as that in adults, and the recommended dosage in patients age 1 year to less than 12 years old is based on body-surface area (bsa) [see dosage and administration ( 2.1 )] . the safety and effectiveness of imbruvica have not been established for this indication in pediatric patients less than 1 year of age. mature b-cell non-hodgkin lymphoma the safety and effectiveness of imbruvica in combination with chemoimmunotherapy were assessed but have not been established based on an open-label, randomized study (nct02703272) in 35 patients, which included 26 pediatric patients age 5 to less than 17 years, with previously treated mature b-cell non-hodgkin lymphoma. the study was stopped for futility. in the randomized population, major hemorrhage and discontinuation of chemoimmunotherapy due to adverse reactions occurred more frequently in the ibrutinib plus chemoimmunotherapy arm compared to the chemoimmunotherapy alone arm. cll/sll, cll/sll with 17p deletion, wm the safety and effectiveness of imbruvica in pediatric patients have not been established in cll/sll, cll/sll with 17p deletion, or wm. of 992 patients in clinical studies of imbruvica for b-cell malignancies or cgvhd, 62% were ≥ 65 years of age, while 22% were ≥ 75 years of age [see clinical studies ( 14.1 , 14.2 , 14.3 )] . no overall differences in effectiveness were observed between younger and older patients. anemia (all grades), pneumonia (grade 3 or higher), thrombocytopenia, hypertension, and atrial fibrillation occurred more frequently among older patients treated with imbruvica [see adverse reactions ( 6.1 )] . adult patients with b-cell malignancies avoid use of imbruvica in patients with severe hepatic impairment (child-pugh class c). the safety of imbruvica has not been evaluated in patients with mild to severe hepatic impairment by child-pugh criteria. reduce the recommended dose when administering imbruvica to patients with mild or moderate hepatic impairment (child-pugh class a and b). monitor patients more frequently for adverse reactions of imbruvica [see dosage and administration ( 2.4 ), clinical pharmacology ( 12.3 )]. patients with cgvhd avoid use of imbruvica in patients with total bilirubin level > 3 x uln (unless of non-hepatic origin or due to gilbert’s syndrome). reduce recommended dose when administering imbruvica to patients with total bilirubin level > 1.5 to 3 x uln (unless of non-hepatic origin or due to gilbert’s syndrome) [see dosage and administration ( 2.4 )] . management of hyperviscosity in wm patients may include plasmapheresis before and during treatment with imbruvica. modifications to imbruvica dosing are not required. instructions for use imbruvica (im-bru-vih-kuh)   (ibrutinib) oral suspension this instructions for use contains information about how to prepare and take or give a dose of imbruvica oral suspension . read this instructions for use before you take or give imbruvica and each time you get a refill. there may be new information. this instructions for use does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment. call your healthcare provider or 1-877-877-3536 if you need help or have any questions about how to take or give imbruvica the right way. important information you need to know before taking or giving imbruvica. - imbruvica is for oral use only. - take or give imbruvica exactly as your healthcare provider tells you to. - if you miss a dose of imbruvica, it can be taken or given as soon as possible on the same day. do not take or give  more than the prescribed dose in 1 day.  - keep these instructions for future use. each imbruvica carton contains (see figure a ): - 1 bottle of imbruvica (called ‘bottle’ in this instructions for use) with pre-inserted bottle adapter (called ‘adapter’ in this instructions for use). do not remove the bottle adapt e r. - 2 reusable 3 ml oral dosing syringes (called ‘syringe’ in this instructions for use) measuring in 0.1 ml increments. p reparing and taking or giving a dose of   imbruvica - check the prescribed dose in milliliters (mls). find this ml marking on the syringe. - if the dose is more than the marking on the syringe, split the dose between syringes as prescribed. - gather bottle and syringe(s) (see figure a ). - check the bottle and make sure that the bottle has imbruvica oral suspension printed on it and the expiration date (“exp”) has not passed. - when opening the bottle for the first time, record the date that is 60 days from the day the bottle is opened underneath the words “discard date” (see figure b ). - use imbruvica within 60 days after first opening the bottle. - shake the bottle well before each use (see figure c ) . - press down and twist the cap counterclockwise to remove it from the bottle (see figure d ). - if there is fluid on top of the adapter, you may wipe it with a clean disposable tissue. - make sure the syringe is clean and dry before use. - push the plunger down all the way. - gently insert tip of the syringe into the adapter. - turn the assembled bottle and syringe upside down (see figure e ). - slowly pull the syringe plunger down, past the number of mls for your prescribed dose (see figure f ). - check for air bubbles and proceed to step 7 for instructions on how to remove air bubbles.  - hold the syringe and tap the sides to send bubbles to the tip. - with the syringe attached to the bottle, push the plunger up to remove the air bubbles from the top (see  figure g ). - after the bubbles are removed, push the plunger up until the top of the colored plunger is even with the markings on the syringe for the prescribed dose.  - turn the assembled bottle upright. - hold the middle of the syringe and carefully remove it from the bottle (see figure h ). - place the bottle aside. - place the tip of the syringe along the inside of the cheek. - slowly push the plunger all the way in to take or give the entire dose (see figure i ). - repeat with second syringe if needed to complete the prescribed dose. - place the cap back on the imbruvica bottle (see figure j ).   - make sure the bottle is tightly closed between each use. - remove the plunger from the syringe. - rinse the plunger and the syringe only with water and air dry (see figure k ). - store the syringe in a clean, dry place. turn over for more    information how to s tore imbruvica   oral suspension - store the bottle between 36°f and 77°f (2°c and 25°c). - imbruvica oral suspension comes in a bottle with a child-resistant cap. - store imbruvica and all medications out of   the reach of children. how to d ispose of imbruvica   - ask your pharmacist how to properly dispose of the medicine. - for syringe disposal, rinse and place in household trash. this instructions for use has been approved by the u.s. food and drug administration. distributed and marketed by: pharmacyclics llc south san francisco, ca 94080 usa and marketed by: janssen biotech, inc. horsham, pa 19044 usa patent http://www.imbruvica.com imbruvica® is a registered trademark owned by pharmacyclics llc  © 2024 pharmacyclics llc © 2024 janssen biotech, inc. 20080493 revised: 2/2024

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

arrotex pharmaceuticals pty ltd - amoxicillin trihydrate, quantity: 57.8 mg/ml (equivalent: amoxicillin, qty 50 mg/ml) - suspension, powder for - excipient ingredients: saccharin sodium; colloidal anhydrous silica; xanthan gum; sodium citrate dihydrate; sunset yellow fcf; sorbitol; flavour - indications: it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms. note. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e. coli (see section 5.1 pharmacodynamic properties - microbiology). respiratory (acute and chronic): h. influenzae; streptococcus; strep. pneumoniae; staphylococcus, nonpenicillinase producing; e. coli (see section 5.1 pharmacodynamic properties - microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e. coli (see section 5.1 pharmacodynamic properties - microbiology), p. mirabilis and strep. faecalis. gonorrhoea: n. gonorrhoeae (nonpenicillinase producing). prophylaxis of endocarditis: amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

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

arrotex pharmaceuticals pty ltd - amoxicillin trihydrate, quantity: 28.9 mg/ml (equivalent: amoxicillin, qty 25 mg/ml) - suspension, powder for - excipient ingredients: sunset yellow fcf; colloidal anhydrous silica; xanthan gum; saccharin sodium; sodium citrate dihydrate; sorbitol; flavour - indications: it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms. note. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e. coli (see section 5.1 pharmacodynamic properties - microbiology). respiratory (acute and chronic): h. influenzae; streptococcus; strep. pneumoniae; staphylococcus, nonpenicillinase producing; e. coli (see section 5.1 pharmacodynamic properties - microbiology). genitourinary tract (complicated and uncomplicated, acute and chronic): e. coli (see section 5.1 pharmacodynamic properties - microbiology), p. mirabilis and strep. faecalis. gonorrhoea: n.gonorrhoeae (nonpenicillinase producing). prophylaxis of endocarditis: amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.