New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - tranexamic acid 100 mg/ml - solution for injection - 100 mg/ml - active: tranexamic acid 100 mg/ml excipient: water for injection - haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. local fibrinolysis may occur in the following conditions: · prostatectomy and bladder surgery · menorrhagia · epistaxis · conisation of the cervix · management of dental extraction in patients with coagulopathies · ulcerative colitis · haematuria · gastrointestinal haemorrhage. general fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: · in obstetrical complications such as abruptio placentae and post-partum haemorrhage · in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - tranexamic acid 100 mg/ml - solution for injection - 100 mg/ml - tranexamic acid 100 mg/ml - tranexamic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - tranexamic acid - solution for injection/infusion - 100 milligram(s)/millilitre - amino acids; tranexamic acid

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - tranexamic acid - injection - 100 mg/ml - tranexamic acid 100 mg/ml

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - tranexamic acid 100 mg/ml - solution for injection - 100 mg/ml - tranexamic acid 500 mg - tranexamic acid

Canada - English - Health Canada

pfizer canada ulc - tranexamic acid - solution - 100mg - tranexamic acid 100mg - hemostatics

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pfizer manufacturing belgium n.v., belgium - tranexamic acid - solution for injection - 100 mg/ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - tranexamic acid - solution for injection - 100mg/1ml

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - tranexamic acid - solution for injection/infusion - tranexamic acid 500 mg/5ml - antihemorrhagics

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

pfizer laboratories div pfizer inc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - cyklokapron® 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. cyklokapron injection is contraindicated: 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 resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see data) . reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see data) . the estimated background risk for 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 the clinically recognized pregnancies is 2–4% and 15–20%, respectively. it is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. for decisions regarding the use of cyklokapron during pregnancy, the potential risk of cyklokapron administration on the fetus should always be considered along with the mother's clinical need for cyklokapron; an accurate risk-benefit evaluation should drive the treating physician's decision. data human data tranexamic acid passes through the placenta. the concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/l, as high as in the maternal blood. there were 13 clinical studies that described fetal and/or neonatal functional issues such as low apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22–36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. animal data in embryo-fetal development studies, tranexamic acid was administered to pregnant mice from gestation day (gd) 6 through gd 12 and rats from gd 9 through gd 14 at daily doses of 0.3 or 1.5 g/kg. there was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. in rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from gd 6 through gd 18. there was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. risk summary published literature reports the presence of tranexamic acid in human milk. there are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cyklokapron and any potential adverse effects on the breastfed child from cyklokapron or from the underlying maternal condition. contraception concomitant use of cyklokapron, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. advise patients to use an effective alternative (nonhormonal) contraceptive method [see warnings and precautions (5.1), drug interactions (7.1)] . there are limited data concerning the use of cyklokapron in pediatric patients with hemophilia who are undergoing tooth extraction. the limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. clinical studies of cyklokapron did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.2), clinical pharmacology (12.3)] . reduce the dosage of cyklokapron in patients with renal impairment, based on the patient's serum creatinine [see dosage and administration (2.2), clinical pharmacology (12.3)] .