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

acrotech biopharma inc - pralatrexate (unii: a8q8i19q20) (pralatrexate - unii:a8q8i19q20) - folotyn is indicated for the treatment of patients with relapsed or refractory peripheral t-cell lymphoma (ptcl). this indication is approved under accelerated approval based on overall response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , folotyn can cause fetal harm when administered to a pregnant woman. there are insufficient data on folotyn use in pregnant women to evaluate for a drug- associated risk. folotyn was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of the clinical dose on a mg/m2 basis. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have

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

viatrexx bio incorporated - bos taurus adrenal gland (unii: m2776swb29) (bos taurus adrenal gland - unii:m2776swb29), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), bos taurus bone marrow (unii: 08x0k2m57p) (bos taurus bone marrow - unii:08x0k2m57p), sus scrofa bone marrow (unii: vp2cn2g7y8) (sus scrofa bone marrow - unii:vp2cn2g7y8), bos taurus red blood cell (unii: 5w4flb0u2c) (bos taurus red blood cell - unii:5w4flb0u2c), - viatrexx-immunexx  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patient

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

viatrexx bio incorporated - anti-interleukin-1.alpha. immunoglobulin g rabbit (unii: ml4qrz1hcl) (anti-interleukin-1.alpha. immunoglobulin g rabbit - unii:ml4qrz1hcl), apomorphine (unii: n21far7b4s) (apomorphine - unii:n21far7b4s), beta-endorphin human (unii: 3s51p4w3xq) (beta-endorphin human - unii:3s51p4w3xq) - viatrexx-ithurts  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients

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

viatrexx bio incorporated - anti-interleukin-1.alpha. immunoglobulin g rabbit (unii: ml4qrz1hcl) (anti-interleukin-1.alpha. immunoglobulin g rabbit - unii:ml4qrz1hcl), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), apis mellifera (unii: 7s82p3r43z) (apis mellifera - unii:7s82p3r43z), beta-endorphin human (unii: 3s51p4w3xq) (metenkefalin - unii:9jez9od3as), bos taurus adrenal gland (unii: m2776swb29) (bos taurus adrenal gland - unii:m2776swb29), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrena - viatrexx-infla  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients w

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

viatrexx bio incorporated - centaurea benedicta (unii: 6l5zl09795) (centaurea benedicta - unii:6l5zl09795), milk thistle (unii: u946sh95ee) (milk thistle - unii:u946sh95ee), ceanothus americanus leaf (unii: 25b1y14t8n) (ceanothus americanus leaf - unii:25b1y14t8n), chelidonium majus (unii: 7e889u5rnn) (chelidonium majus - unii:7e889u5rnn), chionanthus virginicus bark (unii: s9y4b22u2e) (chionanthus virginicus bark - unii:s9y4b22u2e), choline (unii: n91bdp6h0x) (choline - unii:n91bdp6h0x), bos taurus solar plexus (unii: y8h8s1x8ib) (bo - viatrexx-liver  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients w

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

viatrexx bio incorporated - bos taurus adrenal gland (unii: m2776swb29) (bos taurus adrenal gland - unii:m2776swb29), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), brain-derived neurotrophic factor human (unii: 7171wsg8a2) (brain-derived neurotrophic factor human - unii:7171wsg8a2), prasterone (unii: 459ag36t1b) (prasterone - unii:459ag36t1b), malic acid (unii: 817l1n4ckp) (malic acid - unii:817l1n4ckp), basic fibroblast gro - viatrexx-mesenchyme  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patie

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

viatrexx bio incorporated - nitric acid (unii: 411vrn1tv4) (nitric acid - unii:411vrn1tv4), succinic acid (unii: ab6mnq6j6l) (succinic acid - unii:ab6mnq6j6l), escherichia coli (unii: 514b9k0l10) (escherichia coli - unii:514b9k0l10), berberis vulgaris root (unii: itj40jx79u) (berberis vulgaris root - unii:itj40jx79u), equisetum hyemale (unii: 59677rxh25) (equisetum hyemale - unii:59677rxh25), potassium nitrate (unii: ru45x2jn0z) (nitrate ion - unii:t93e9y2844), beef kidney (unii: 5hoc10fsic) (beef kidney - unii:5hoc10fsic), pork kidne - viatrexx-ki-ub  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients w

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

viatrexx bio incorporated - bos taurus adrenal gland (unii: m2776swb29) (bos taurus adrenal gland - unii:m2776swb29), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), aldosterone (unii: 4964p6t9rb) (aldosterone - unii:4964p6t9rb), androsterone (unii: c24w7j5d5r) (androsterone - unii:c24w7j5d5r), adenosine cyclic phosphate (unii: e0399ozs9n) (adenosine cyclic phosphate - unii:e0399ozs9n), cholesterol (unii: 97c5t2uq7j) (cholesterol - unii:97c5t2uq7j), prasterone (unii: 459ag36t1b) (prasterone - - viatrexx-male plus  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patien

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mundipharma pharmaceuticals sdn. bhd. - pralatrexate -

European Union - English - EMA (European Medicines Agency)

allos therapeutics ltd - pralatrexate - lymphoma, t-cell - antineoplastic agents - treatment of peripheral t-cell lymphoma,