USA - engelsk - NLM (National Library of Medicine)

alvogen, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated)  are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred  [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insuffici

USA - engelsk - NLM (National Library of Medicine)

alvogen, inc. - primaquine phosphate (unii: h0982hf78b) (primaquine - unii:mvr3634gx1) - primaquine 26.3 mg

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 7.7 mg in 1 g - superficial dermatophyte infections ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, or epidermophyton floccosum . seborrheic dermatitis ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp. ciclopirox gel is contraindicated in individuals who have shown hypersensitivity to any of its components.

USA - engelsk - NLM (National Library of Medicine)

alvogen, inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or - vitamin d toxicity [see warnings and precautions (5.1) ]. pregnancy category c. paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times a human dose of 14 mcg or 0.24 mcg/kg (based on body surface area, mcg/m2 ), and when administered to rats at a dose two times the 0.24 mcg/kg human dose (based on body surface area, mcg/m2 ). at the highest dose tested, 20 mcg/kg administered three times per week in rats (13 times the 14 mcg human dose based on surface area, mcg/m2 ), there was a significant i

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 5 mg in 1 ml - midazolam injection, usp is indicated: injectable midazolam hydrochloride is contraindicated in patients with a known hypersensitivity to the drug. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam hydrochloride; patients with glaucoma have not been studied. midazolam hydrochloride is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. midazolam hydrochloride is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see warnings and precautions, pediatric use ). midazolam hydrochloride contains midazolam, a schedule iv control substance. midazolam was actively self-administered in primate models used to assess the positive

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: • in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. • in patients with active intravascular clotting [see warnings and precautions (5.1)]. • in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions (5.3)]. risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that

USA - engelsk - NLM (National Library of Medicine)

alvogen, inc. - pyridostigmine bromide (unii: kvi301na53) (pyridostigmine - unii:19qm69hh21) - pyridostigmine bromide 180 mg - pyridostigmine bromide extended release tablets is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. care should be observed in the use of atropine for counteracting side effects, as discussed below.

USA - engelsk - NLM (National Library of Medicine)

alvogen, inc - gadopentetate dimeglumine (unii: rh248g8v27) (gadopentetate - unii:v7ok6j19hq) - gadopentetate dimeglumine 469.01 mg in 1 ml - gadopentetate dimeglumine injection is indicated for use with magnetic resonance imaging (mri) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. gadopentetate dimeglumine injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. gadopentetate dimeglumine is indicated for use with mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. gadopentetate dimeglumine injection is indicated for use in mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart). gadopentetate dimeglumine is contraindicated in patients with:

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l), nitrofurantoin monohydrate (unii: e1qi2cqq1i) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin 25 mg - nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of escherichia coli or staphylococcus saprophyticus . nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader tissue distribution of other therapeutic agents

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - butalbital 50 mg - butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. abuse and dependence: butalbital: barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin b