Ireland - English - HPRA (Health Products Regulatory Authority)

agfa healthcare imaging agents gmbh - gadopentetate dimeglumine - solution for injection - 0.5 mmol/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

sanochemia pharmazeutika ag - gadopentetate dimeglumine - solution for injection - 500 micromol

Canada - English - Health Canada

bayer inc - gadopentetate dimeglumine - solution - 469mg - gadopentetate dimeglumine 469mg - other diagnostic agents

Kenya - English - Pharmacy and Poisons Board

bayer pharma ag bayer pharma ag 13342 berlin germany - gadopentetate dimeglumine - solution for injection - each ml contains 0.5 mmol gadopentetate… - contrast media - magnetic resonance imaging:

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

bayer australia ltd - dimeglumine gadopentetate -

Singapore - English - HSA (Health Sciences Authority)

dch auriga singapore - gadobenate dimeglumine; gadobenate dimeglumine - injection - 529 mg/ml - gadobenate dimeglumine 529 mg/ml; gadobenate dimeglumine 529 mg/ml

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

bracco diagnostics inc - gadobenate dimeglumine (unii: 3q6ppc19po) (gadolinium cation (3+) - unii:azv954tz9n) - multihance is indicated for intravenous use in magnetic resonance imaging (mri) of the central nervous system (cns) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. multihance is indicated for use in magnetic resonance angiography (mra) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. multihance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [see warnings and precautions (5.3) ]. risk summary gbcas cross the placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data ). in animal reproduction studies, gadobenate dimeglumine has been shown to be teratogenic in rabbits following repeated intravenous administration during organogenesis at doses up to 6 times the recommended human dose. there were no adverse developmental effects observed in rats with intravenous administration of gadobenate dimeglumine during organogenesis at doses up to three times the recommended human dose (see data). because of the potential risks of gadolinium to the fetus, use multihance only if imaging is essential and cannot be delayed. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and is 15 to 20%, respectively. data human data contrast enhancement is visualized in the placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the maternal indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. reproductive toxicology gadobenate dimeglumine has been shown to be teratogenic in rabbits when administered intravenously at 2 mmol/kg/day (6 times the recommended human dose based on body surface area) during organogenesis (day 6 to 18) inducing microphthalmia/small eye and/or focal retinal fold in 3 fetuses from 3 separate litters. in addition, multihance administered intravenously at 3 mmol/kg/day (10 times the recommended human dose based on body surface area) has been shown to increase intrauterine deaths in rabbits. there was no evidence that multihance induced teratogenic effects in rats at doses up to 2 mmol/kg/day (3 times the recommended human dose based on body surface area), however, rat dams exhibited no systemic toxicity at this dose. there were no adverse effects on the birth, survival, growth, development and fertility of the f1 generation at doses up to 2 mmol/kg in a rat peri- and post-natal (segment iii) study. risk summary limited literature reports that breastfeeding after gadobenate dimeglumine administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose. there is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. additionally, there is limited gbca gastrointestinal absorption. the developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for multihance and any potential adverse effects on the breastfed infant from multihance or from the underlying maternal condition. multihance is approved for intravenous use for mri of the cns to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to less than 17 years of age. pediatric use is based on evidence of effectiveness in adults and in 202 pediatric patients 2 years of age and older, in addition to experience in 105 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dose adjustment according to age is necessary in pediatric patients two years of age and older. for pediatric patients, less than 2 years of age, the recommended dosage range is 0.1 to 0.2 ml/kg [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of multihance has not been established in preterm neonates. of the total number of 4967 adult subjects in clinical studies of multihance, 33% were 65 or older. no overall differences in safety or effectiveness were observed between these elderly subjects and the younger subjects. the drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to multihance may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function it may be useful to monitor renal function.

Namibia - English - Namibia Medicines Regulatory Council

bayer (pty) ltd - gadopentetate dimeglumine - injection - each 1 ml solution contains 469,01 mg gadopentetate dimeglumine

Namibia - English - Namibia Medicines Regulatory Council

bayer (pty) ltd - gadopentetate dimeglumine - injection - each 1 ml solution contains 469,01 mg gadopentetate dimeglumine

Namibia - English - Namibia Medicines Regulatory Council

bayer (pty) ltd - gadopentetate dimeglumine - injection - each 1 ml solution contains 469,01 mg gadopentetate dimeglumine