Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الرام للصناعات الدوائية - ram pharmaceutical industries co. ltd. - paracetamol 33.3 mg/5ml, oxomemazine (as hcl) 1.65 mg/5ml, guaifenesin 33.3 mg/5ml, sodium benzoate 33.3 mg/5ml - 33.3 mg/5ml, (as hcl) 1.65 mg/5ml, 33.3 mg/5ml, 33.3 mg/5ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الرام للصناعات الدوائية - ram pharmaceutical industries co. ltd. - paracetamol 33.3 mg/5ml, oxomemazine (as hcl) 1.65 mg/5ml, guaifenesin 33.3 mg/5ml, sodium benzoate 33.3 mg/5ml - 33.3 mg/5ml, (as hcl) 1.65 mg/5ml, 33.3 mg/5ml, 33.3 mg/5ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة الرام للصناعات الدوائية - ram pharmaceutical industries co. ltd. - paracetamol 33.3 mg/5ml, oxomemazine (as hcl) 1.65 mg/5ml, guaifenesin 33.3 mg/5ml, sodium benzoate 33.3 mg/5ml - 33.3 mg/5ml, (as hcl) 1.65 mg/5ml, 33.3 mg/5ml, 33.3 mg/5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 0.1 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts); allergen extracts 1 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts); allergen extracts 10 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) - solution for injection - active: allergen extracts 0.1 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 1 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 10 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 10 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) - solution for injection - 10 ic/ml - active: allergen extracts 10 ic/ml (fraxinus excelsior (33.33%), olea europaea (33.33%), ligustrum vulgare (33.33%) pollen extracts) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water

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

sandoz inc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron tablets are contraindicated in patients: risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see data ]. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth def

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

allergan, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - namenda xr®  is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. namenda xr is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk   summary   there are no adequate data on the developmental risk associated with the use of namenda xr in pregnant women.  adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of namenda xr [see   data].    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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal   data oral administration of memantine 

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

mckesson corporation dba sky packaging - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 8 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine hydrobromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal

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

ascend laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride tablets are indicated for the treatment of: - attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults - narcolepsy - hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. hypersensitivity reactions, such as angioedema and anaphylacticreactions, have been reported in patients treated with methylphenidate[seeadverse reactions (6.1)]. - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 daysfollowingdiscontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)]. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womens

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

aspen veterinary resources®, ltd - marbofloxacin (unii: 8x09wu898t) (marbofloxacin - unii:8x09wu898t) - delaquintm  chewable tablets are indicated for the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. marbofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. marbofloxacin is contraindicated in immature dogs during the rapid growth phase (small and medium breeds up to 8 months of age, large breeds up to 12 months of age and giant breeds up to 18 months of age). marbofloxacin is contraindicated in cats under 12 months of age. marbofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.