Den europeiske union - engelsk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - hiv infections - antivirals for systemic use - aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of hiv-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.this indication is based on the results of two phase-iii studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-ii study investigating pharmacokinetics, safety and efficacy of aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.in deciding to initiate treatment with aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of aptivus. initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to aptivus, co-administered with low-dose ritonavir.

USA - engelsk - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - tipranavir (unii: zzt404xd09) (tipranavir - unii:zzt404xd09) - tipranavir 250 mg - aptivus, co-administered with ritonavir, is indicated for combination antiretroviral treatment of hiv-1 infected adults and pediatric patients weighing 36 kg or higher who are treatment-experienced and infected with hiv-1 strains resistant to more than one protease inhibitor (pi) [see use in specific populations (8.4)] . this indication is based on analyses of plasma hiv-1 rna levels in two controlled studies of aptivus/ritonavir of 48 weeks duration in treatment-experienced adults and one open-label 48-week study in pediatric patients. the adult studies were conducted in clinically advanced, 3-class antiretroviral (nrti, nnrti, pi) treatment-experienced adults with evidence of hiv-1 replication despite ongoing antiretroviral therapy. the following points should be considered when initiating therapy with aptivus/ritonavir: - the use of aptivus/ritonavir in treatment-naïve patients is not recommended [see warnings and precautions (5.2) ]. - the use of other active agents with aptivus/ritonavir is associated with a greater likelihood of treatment response [see microbiology (12.4) and clinical studies (14) ]. - genotypic or phenotypic testing and/or treatment history should guide the use of aptivus/ritonavir [see microbiology (12.4) ]. the number of baseline primary protease inhibitor mutations affects the virologic response to aptivus/ritonavir [see microbiology (12.4) ]. - use caution when prescribing aptivus/ritonavir to patients with elevated transaminases, hepatitis b or c co-infection or patients with mild hepatic impairment [see warnings and precautions (5.2) ]. - liver function tests should be performed at initiation of therapy with aptivus/ritonavir and monitored frequently throughout the duration of treatment [see warnings and precautions (5.2) ]. - the drug-drug interaction potential of aptivus/ritonavir when co-administered with other drugs must be considered prior to and during aptivus/ritonavir use [see contraindications (4) and drug interactions (7) ]. - use caution when prescribing aptivus/ritonavir in patients who may be at risk for increased bleeding or who are receiving medications known to increase the risk of bleeding [see warnings and precautions (5.5) ]. there are no study results demonstrating the effect of aptivus/ritonavir on clinical progression of hiv-1. - aptivus is contraindicated in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.2) ]. - aptivus/ritonavir is contraindicated when co-administered with drugs that are highly dependent on cyp3a for clearance or are potent cyp3a inducers (see table 1) [see drug interactions (7.2) ]. due to the need for co-administration of aptivus with ritonavir, please refer to the ritonavir prescribing information for a description of ritonavir contraindications. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aptivus during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr and an expanded access program are not sufficient to adequately assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. tipranavir use during pregnancy has been evaluated in a limited number of women as reported by the apr and an expanded access program, and available data show no birth defects in 13 first trimester exposures (see data) compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. in animal reproduction studies, fetal toxicities were observed with tipranavir at maternally toxic doses with systemic exposures (auc) less than those in humans at the recommended human dose (rhd) (see data) . data human data based on prospective reports to the apr and an expanded access program for approximately 17 live births following exposure to tipranavir-containing regimens (including 13 live births exposed in the first trimester and 4 live births exposed in the second/third trimester), there were no birth defects reported in live-born infants. tipranavir has been shown to cross the placenta. animal data tipranavir was administered orally to pregnant rats (at 0, 40, 400, or 1000 mg/kg/day from gestation day 6 to 17) and rabbits (at 0, 75, 150, or 375 mg/kg/day from gestation day 6 to 20). in rats, fetal toxicities including decreased body weight and sternebrae ossification occurred at maternally toxic doses (≥400 mg/kg/day) (approximately 0.8 times human exposure at the rhd). in rabbits, fetal toxicities including decreased fetal body weights, wavy ribs, and bent femurs occurred at a maternally toxic dose (375 mg/kg/day) (approximately 0.05 times human exposure at the rhd). maternal toxicity included an increased incidence of abortions at doses ≥150 mg/kg/day (approximately 0.05 times human exposure at the rhd). in the pre/post-natal development study, tipranavir was administered orally to rats at 0, 40, 400, 1000 mg/kg/day from gestation day 6 to lactation day 21. the only significant effect observed was growth inhibition of the offspring at maternally toxic doses (≥400 mg/kg/day) (approximately 0.8 times human exposure at the rhd). risk summary there is no information regarding the presence of tipranavir in human milk, the effects on the breastfed infant, or the effects on milk production. tipranavir is present in rat milk (see data) . potential risks of breastfeeding include: (1) hiv-1 transmission (in hiv-1 negative infants), (2) developing viral resistance (in hiv-1-positive patients), and (3) adverse reactions in a breastfed infant similar to those seen in adults. data in a lactation study, tipranavir was excreted into the milk of lactating rats following a single oral dose of tipranavir (10 mg/kg) on lactation/postpartum day 14, with a maximal milk concentration achieved 2 hours post-administration (milk concentration 0.13 times that of maternal plasma concentration). contraception use of aptivus may reduce the efficacy of estrogen-based oral contraceptives. advise patients to use alternative methods of nonhormonal contraception [see drug interactions (7.2) ]. the safety and effectiveness of aptivus, co-administered with ritonavir have been established in pediatric patients for combination antiretroviral treatment of hiv-1 infected pediatric patients weighing 36 kg or higher who are treatment-experienced and infected with hiv-1 strains resistant to more than one protease inhibitor (pi) [see indications and usage (1) and dosage and administration (2.2)] . the safety, pharmacokinetic profile, and virologic and immunologic responses of aptivus in those weighing 36 kg or higher were similar to those observed in adults. however, rash was reported more frequently in pediatric subjects than in adults [see warnings and precautions (5.6), adverse reactions (6.2), clinical pharmacology (12.3), and clinical studies (14.2) ]. the safety and effectiveness of aptivus, co-administered with ritonavir have been established in pediatric patients greater than 2 years of age or weighing less than 36 kg, but not recommended due to lack of a suitable pediatric formulation. clinical studies of aptivus/ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. in general, caution should be exercised in the administration and monitoring of aptivus in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. tipranavir is principally metabolized by the liver. caution should be exercised when administering aptivus/ritonavir to patients with mild (child-pugh class a) hepatic impairment because tipranavir concentrations may be increased [see clinical pharmacology (12.3) ]. aptivus/ritonavir is contraindicated in patients with moderate or severe (child-pugh class b or child-pugh class c) hepatic impairment [see contraindications (4) ].

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

morus alba) pollen 500micrograms/ml solution for skin prick test (inmunotek - white mulberry (morus alba) pollen allergen extract - solution for skin-prick test

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

cscm pty ltd - crocus sativus, quantity: 20 mg - capsule, hard - excipient ingredients: gelatin; methyl hydroxybenzoate; sodium lauryl sulfate; microcrystalline cellulose; purified water; titanium dioxide; allura red ac; propyl hydroxybenzoate; brilliant blue fcf; amaranth; macrogol 6000 - traditionally used in western herbal medicine to maintain/support eye health ; traditionally used in western herbal medicine to maintain/support healthy eyesight/vision

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

agbitech pty ltd - nuclear polyhedrosis virus of helicoverpa armigera - liquid concentrate - nuclear polyhedrosis virus of helicoverpa armigera biological-virus active 0.0 p - insecticide - adzuki bean | apple | blackberry | blueberry | boysenberry | brassica leafy vegetables - see label | brassica vegetables | broad - helicoverpa armigera | helicoverpa punctigera | bollworm | corn earworm | cotton bollworm | native budworm | tobacco budworm | tomato grub

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

boehringer ingelheim pty ltd - tipranavir -

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

b braun australia pty ltd - 32885 - wire cutter - wire cutters are used to cut implant wires and similar foreign bodies.

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

stryker australia pty ltd - 43660 - wire-driving power tool attachment - intended to connect to a surgical power tool system motor to perform a wire driving/insertion function when an appropriate orthopaedic wire is inserted.

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

zimmer biomet pty ltd - 43660 - wire-driving power tool attachment - adapter for power drill to simplify placing and removing of k-wires.