Consider higher doses if the mother has been receiving oral anticoagulants. Phytonadione is a man-made form of vitamin K, which occurs naturally in the body. The recommended dosage of phytonadione injectable emulsion is 1 mg given either subcutaneously or intramuscularly. Other diluents should not be used. If you are a consumer or patient please visit Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk[seeWarnings and Precautions (5.1)]. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Severe reactions, including fatalities, have occurred during and immediately after IV injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates; antibiotics) is suggested as an alternative to administering concurrent phytonadione injectable emulsion. & Articles, All Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Last Updated: November 15, 2022 Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Phytonadione Injectable Emulsion, USP. Benzyl alcohol as a preservative has been associated with toxicity in newborns. If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated. What is this medicine? Discontinue phytonadione injectable emulsion for skin reactions and institute medical management. The resulting gamma-car-boxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. Phytonadione Injectable Emulsion, USP does not affect the anticoagulant action of heparin. Vitamin K injection, Pfizer, 2 mg/mL, 0.5 mL ampule, 25 count, NDC 00409-9157-01. (8.4). Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from phytonadione injectable emulsion overdose. Copy the URL below and paste it into your RSS Reader application. Get Label RSS Feed, 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. Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution of vitamin K 1, with a pH of 4.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. The following serious adverse reactions are described elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Phytonadione Injectable Emulsion 25x1 ml ACB902 ACB903 ACB904 ACB905 03.2021. The following adverse reactions have been identified during post-approval use of phytonadione injectable emulsion. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. In rare instances 50 mg may be required. 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. Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis). Pfizer has Vitamin K (phytonadione) 2 mg/mL 0.5 mL ampules available in limited supply. When diluted, start administration of phytonadione injectable emulsion immediately after dilution. (1.2), Injection: 2 mg/mL and 10 mg/mL single-dose vials. There are no data on the effects of phytonadione injectable emulsion on the breastfed child or on milk production. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of phytonadione injectable emulsion. Consider higher doses if the mother has been receiving oral anticoagulants. Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection . However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors. View NDC Code(s)NEW! this version. Each milliliter contains phytonadione 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as . anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. (5.1), Cutaneous Reactions: May occur with parenteral use. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Events, (What hives, itching, skin rash. Hypersensitivity to any component of this medication. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. 5.2 Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative. View full details $ 8,999.00 Ascorbic Acid (Vitamin C for Injection) 25,000 mg/ 50 mL Multidose Vial BULK (25/Tray) **Requires Refrigeration** McGuff Company . Phytonadione injectable emulsion should be given to a pregnant woman only if clearly needed. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 12 Dec 2022) and others. Hypersensitivity to phytonadione or any other componet of this medication[see Warnings and Precautions (5.1)]. Files, All Mapping Vitamin K injection, Cipla USA, 1 mg/0.5mL, 0.5 mL vial, 10 count, NDC 69097-0709-96, Vitamin K injection, Cipla USA, 10 mg/mL, 1 mL vial, 10 count, NDC 69097-0708-96, Vitamin K injection, Dr. Reddy's, 10 mg/mL, 1 mL ampule, 25 count, NDC 43598-0405-16, Vitamin K injection, Pfizer, 10 mg/mL, 1 mL ampule, 25 count, NDC 00409-9158-01. Advise the patient and caregivers of the risk of gasping syndrome associated with the use of products that contain benzyl alcohol (including phytonadione injectable emulsion) in neonates, infants, and pregnant women [see Warnings and Precautions (5.2)]. If you are a consumer or patient please visit Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of phytonadione injectable emulsion. Phytonadione injection has been administered orally and is typically used when lower oral doses (e.g., 1 mg) are needed and no oral product is commercially available. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine. The estimated background risk for the indicated population is unknown. Time of onset ranged from 1 day to a year after parenteral administration. It has a molecular weight of 450.70. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. (, When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known[see Warnings and Precautions (5.2)]. Citations, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION, PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION, Report Adverse 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Copy the URL below and paste it into your RSS Reader application. Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. ), 6 Files, Presentations Use the lowest effective dose of phytonadione injectable emulsion. 06.2021. Events, (What Get Label RSS Feed, To correct excessively prolonged prothrombin time caused by oral anticoagulant therapy2.5 to 10 mg or up to 25 mg initially is recommended. HOW SUPPLIED Vitamin K 1 Injection (Phytonadione Injectable Emulsion, USP) is supplied as follows: Unit of Sale Concentration NDC 0409-9157-01 Bundle of 5 clamcells containing 5 single-dose ampuls 1 mg/0.5 mL NDC 0409-9158-01 Bundle of 5 clamcells Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of phytonadione injectable emulsion. Phytonadione is present in breastmilk. The recommended dosage of Phytonadione Injectable Emulsion, USP is 1 mg given either subcutaneously or intramuscularly. Use the lowest dose of Phytonadione Injectable Emulsion, USP. Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorlessliquid. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data]. Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. The preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants. When prescribing phytonadione injectable emulsion in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including phytonadione injectable emulsion (contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. ), More about getting RSS News & Updates from DailyMed, Hemorrhagic Disease of the Newborn Prophylaxis, 1 mg SC or It (Higher doses may be necessary if the mother has been receiving oral anticoagulants), Anticoagulant-Induced Prothrombin Deficiency(caused by coumarin or indanedione derivatives), 2.5 mg to 10 mg or up to 25 mg (rarely 50 mg), Hypoprothrombinemia Due to other causes(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis), 2.5 mg to 25 mg ormore (rarely up to 50 mg), 1 mL in 1 AMPULE; Type 0: Not a Combination Product, analysis(43598-405) , manufacture(43598-405), 5 Warnings and Precautions, Cutaneous Reactions (5.3) 04/2018, Phytonadione Injectable Emulsion, USP is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when cause by vitamin K deficiency or interference with vitamin K activity. If available, preservative-free phytonadione injectable emulsion is recommended when phytonadione injectable emulsion is needed during lactation [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Read more Did you find an answer to your question? Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose vials. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not reasible and the serious risk is justified. View NDC Code(s)NEW! Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution of vitamin K 1, with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes.Phytonadione injectable emulsion, USP is available in 1 mg (2 mg/mL) and 10 mg (10 mg/mL) single-dose ampuls. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of phytonadione injectable emulsion. Reason for the Shortage. RxNorm, If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Animal reproduction studies have not been conducted with phytonadione. Administer phytonadione injectable emulsion subcutaneously whenever feasible. Each milliliter contains phytonadione 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. Events, Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Therefore,all of the above diluents should be preservative-free. (5.1). PubMed, (See Box Warning.) Phytonadoine is 2-methyl-3-phyty-1, 4-naphthoquinone. Therefore, all of the above diluents should be preservative-free (see WARNINGS). Design: Single-dose, two-way crossover in-vivo. The recommended dosage of phytonadione injectable emulsion is 0.5 mg to 1 mg within one hour of birth for a single dose. Very little vitamin K accumulates in tissues. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.2)]. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. See full prescribing information for PHYTONADIONE INJECTABLE EMULSION. When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see Warnings and Precautions (5.1)]. It is not known whether this drug is excreted in human milk. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. The developmental and health benefits of breastfeeding should be considered along with the clinical need for Phytonadione Injectable Emulsion, USP and any potential adverse effects on the breasfed child from Phytonadione Injectable Emulsion, USP or from the underlying maternal condition. Amphastar has Vitamin K (phytonadione) 2 mg/mL 0.5 mL syringes available in limited supply. The preservative benzyl alcohol can cause serious adverse events and death when administgered intravenously to neonates and infants. Phytonadione Injectable Emulsion, USP is not a clotting agent, but overzealous therapy with Phytonadione Injectable Emulsion, USP may restore conditions which originally permitted thromboembolic phenomena. The intravenous LD 50 of Vitamin K 1 Injection (Phytonadione Injectable Emulsion, USP) in the mouse is 41.5 and 52 mL/kg for the 0.2% and 1% concentrations,. this version. It is . (3), Hypersensitivity to any component of this medication. 04.2021. Phytonadione injectable emulsion, USP contains glacial acetic acid for pH adjustment to 6.3 (4.5 7.0). Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.. A phytonadione injection may cause a serious allergic reaction. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine. In normal animals and humans, phytonadione is virtually devoid of activity. SHARE THIS. (, Administer phytonadione injectable emulsion by the subcutaneous route, whenever possible. Because some of these reactions were reported voluntarily from a population of uncertain size. Phytonadione injectable emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Pediatric. Labels, All Index At M/s Immacule Lifesciences Pvt. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. A single intramuscular dose of phytonadione injectable emulsion 0.5 to 1 mg within one hour of birth is recommended. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion, USP. The recommended dosage of Phytonadione Injectable Emulsion, USP is 0.5 mg to 1 mg within one hour of birth for a single dose. Advise the patient and caregivers to report the occurrence of new rashes after receiving phytonadione injectable emulsion. Keep ampules in carton until time of use. Brand Name: AquaMEPHYTON. The action of the aqueous dispersion, when administered intravenously, is generally detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. Created August 2, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Phytonadione injectable emulsion does not affect the anticoagulant action of heparin. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of phytonadione injection in neonates. The following adverse reactions associated with the use of Phytonadione Injectable Emulsion, USP were identified in clinical studies or postmarketing reports. Protect Phytonadione Injectable Emulsion, USP from light at all times. Severe reactions, including fatalities, have also been reported following IM administration. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particuarly in premature infants, may result from Phytonadione Injectable Emulsion, USP overdose. Studies of carcinogenicity, genotoxicity or impairment of fertility have not been conducted with phytonadione. Protect from light at all times. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. Other diluents should not be used. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. The coagulant effects of Phytonadione Injectable Emulsion, USP are not immediate; improvement of INR may take 1-8 hours. Evaluate INR after 6-8 hours, and repeat dose if INR remains prolonged. Files, All Mapping Phytonadione (injection) is a vitamin that is FDA approved for the treatment of coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose vials. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Phytonadione Injectable Emulsion, USP may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione Injectable Emulsion, USP are used. When diluted, start administration of Phytonadione Injectable Emulsion, USP immediately after dilution. There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations]. (3) (3), Hypersensitivity to any component of this medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Cardiac Disorders: Tachycardia, hypotension. Each milliliter of phytonadione injectable emulsion, USP contains the following inactive ingredients: 70 mg polyoxyl 35 castor oil, 37.5 mg dextrose monohydrate, 9 mg benzyl alcohol (preservative), and water for injection. Phytonadione injectable emulsion contains benzyl alcohol, which has been associated with gasping syndrome in neonates. We comply with the HONcode standard for trustworthy health information. Labels, All Index View Labeling Archives, Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including phytonadione injectable emulsion. Phytonadione is a man-made form of vitamin K, which occurs naturally in the body. A normal INR may often be obtained in 12 to 14 hours. Monitor international normalized ratio (INR) regularly and as clinical conditions indicate. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of phytonadione injectable emulsion. Updated November 15, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Anticoagulant-Induced Hypoprothrombinemia: Hypoprothrombinemia Due to Other Causes (Non-Anticoagulation-Induced Hypoprothrombinemia): Amount of Phytonadione injectable emulsion In Container, All Drug Administration of vitamin K1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. After absorption phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). (6) (6), To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd at 1-866-604-3268, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Phytonadione injection was packaged in 0.75 mL aliquots in amber . Give IM injection in adults and older children in upper outer quadrant of buttocks. Parenteral drug products should be . However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis). A failure to respond (shortening of the INR in 2 to 4 hours) may indicate another diagnosis or coagulation disorder. General disorders and administration site conditions: Generalized flushing; pain, swelling, and tenderness at injection site. (8.2), Pediatric Use: The safety and effectiveness of Phytonadione Injectable Emulsion, USP in pediatric patients from 6 months from 17 years have not been established. Vitamin K for Injection (Phytonadione Injectable Emulsion) 10 mg/mL Single-dose Vials 1 mL by Cipla USA (NDC: 69097-0708-96). Evaluate INR after 6-8 hours, and repeat dose if INR remains prolonged. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. It treats and prevents low levels of blood clotting . The coagulant effects of phytonadione injectable emulsion are not immediate; improvement of INR may take 1-8 hours. An immediate coagulant effect should not be expected after administration of phytonadione. There is no evidence to suggest that the small amount of benzyl alcohol contained in phytonadione injectable emulsion, USP, when used as recommended, is associated with toxicity. There is no evidence to suggest that the small amount of benzyl alcohol contained in Vitamin K 1 Injection (Phytonadione Injectable Emulsion, USP), when used as recommended, is associated with toxicity. If you are a consumer or patient please visit Amphastar did not provide a reason for the shortage. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Phytonadione is not a clotting agent, but overzealous therapy with phytonadione injectable emulsion may restore conditions which originally permitted thromboembolic phenomena. Discontinue Phytonadione Injectable Emulsion, USP for skin reactions and institute medical management. Skin and Subcutaneous Tissue Disorders: Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=1add4de5-0f9c-453e-9dd5-abb8077b566a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. This therapy, however, does not correct the underlying disorder and phytonadione injectable emulsion should be given concurrently. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. Clinical Trials, Disease-associated maternal and/or embryo/fetal risk. Use benzyl alcohol-free formulations in neonates and infants, if available. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. this version. The recommended dosage of phytonadione injectable emulsion is based on whether the hypoprothrombinemia is anticoagulant-induced (e.g., due to coumarin or indanedione derivatives) or non-anticoagulant-induced (e.g., due to antibiotics; salicylates or other drugs; factors limiting absorption or synthesis) as follows: Repeated large doses of phytonadione injectable emulsion are not warranted in liver disease if the initial response is unsatisfactory. is this? Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk. Ltd. India, Boxed Warnings, A normal INR may often be obtained in 12 to 14 hours. 1. Whenever possible, phytonadione injectable emulsion, should be given by the subcutaneous route. (, Cutaneous Reactions: May occur with parenteral use. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. See full prescribing information for complete boxed warning. The "gasping syndrome" is characterized by central system depression, metabolic acidosis, and gasping respirations. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. The American Academy of Pediatrics recommends that phytonadione be given to the newborn. If Phytonadione is needed during pregnancy, consider using a benzyl alcohol-free formulation[see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Phytonadione Injectable Emulsion, USP is a yellow, sterile, aueous colloidal solution and is supplied in unit use packages containing one single-dose vial and a SAF-T-Jet vial injector, 27 G. x 1/2" needle. It is also not known whether phytonadione injectable emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Discard unused portions of diluted solution as well as unused contents of the vial. 43598-405-16, WARNING INTRAVENOUS AND INTRAMUSCULAR USE. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessare (i.e., heparin sodium). Its empirical formula is C31H46O2 and its molecular structure is: Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 4.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Whole blood or component therapy may be indicated if bleeding is excessive. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium. In pregnant rats receiving vitamin K1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. (4), Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. The estimated background risk for the indicated population is unknown. Phytonadione is readily absorbed following intramuscular administration. PHYTONADIONE (fye toe na DYE one) is a man-made form of vitamin K. . Whenever possible, administer phytonadione injectable emulsion by the subcutaneous route [see Boxed Warning]. Do not give this medicine to a child without medical advice. This activity reviews the indications, contraindications, activity, adverse events, and other critical elements of phytonadione therapy in the clinical setting related to the essential points needed by members of an . Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number, Boxed Warnings, (, Lactation: If available, use the preservative-free formulation in lactating women. Pain, swelling, and tenderness at the injection site may occur. Treatment of Vitamin K Deficiency Bleeding in Neonates. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. Immune System Disorders: Fatal hypersensitivity reactions, anaphylactic reactions. In pregnant rats receiving vitamin K1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. Prothrombin time should be checked regularly as clinical conditions indicate. (See PRECAUTIONS, Pediatric Use. Injection: 1 mg/0.5 mL single-dose vial and a SAF-T-Jet vial injector. Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion, USP. Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. (current), Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; (, Hypoprothrombinemia due to antibacterial therapy; (, Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; (, Other drug-induced hypoprothrombinemia where is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. yellow eyes or skin. Form/Route: Injectable/Injection. (6). In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated. (4) (4), Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. Phytonadione, Vitamin K1 injection. Whenever possible, administer benzyl alcohol-free formulations in pediatric patients[see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Phytonadione is readily absorbed following intramuscular administration. Time of onset ranged from 1 day to a year after parenteral administration. When prescribing phytonadione injectable emulsion in infants consider the combined daily metabolic load of benzyl alcohol from all sources including phytonadione injectable emulsion (phytonadione injectable emulsion contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Whenever possible, administer Phytonadione Injectable Emulsion, USP by the subcutaneous route[see Boxed Warning]. Some patients have exhibited these severe reactions on receiving phytonadione for the first time.Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified. (7). It is usually given by a health care . Avoid use of other diluents that may contain benzyl alcohol, which can cause serious toxicity in newborns or low birth weight infants [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)]. Type of study: Subcutaneous administration . In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Dosage and Administration(2.1)]. Report Adverse Background: Vitamin K, or phytonadione, is available in both injectable and oral formulations. Directions for Dilution. Cipla USA has Vitamin K injection available. (2.1), When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. PHYTONADIONE (fye toe na DYE one) is a man-made form of vitamin K. This medicine is used to treat vitamin K deficiency or bleeding problems caused by various disorders. Select one or more newsletters to continue. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known[see Use in Specific Populations (8.1, 8.2 and 8.4)]. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified[see Dosage and Administration (2.1)]. Transient flushing sensations and peculiar sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. Empiric administration of phytonadione should not replace proper laboratory evaluation of the coagulation mechanism. Phytonadione injectable emulsion is indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with phytonadione metabolism, e.g., salicylates. Phytonadione, Vitamin K1 injection May 06, 2021 . Its empirical formula is C31H46O2 and its molecular structure is: Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Updated Labels, All Index It has a molecular weight of 450.70.Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Recommended studies: 2 studies. Warning. Baseline concentrations should be determined for each dosing Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. There are not data on the effects of Phytonadione Injectable Emulsion, USP on the breastfed child or on milk production. Skin and Subcutaneous Tissue Disorders: Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans. See 17 for PATIENT COUNSELING INFORMATION. View NDC Code(s)NEW! Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. These reactions may be delayed for up to a year after treatment [see Warnings and Precautions (5.3)]. Store container in closed original carton until contents have been used. Use of phytonadione injection for prophylaxis and treatment of vitamin K deficiency is based on published clinical studies. Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. pH is 6.3 (5.0 to 7.0). Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate. (. Parenteral administration of vitamin K replacements (including phytonadione injectable emulsion) may cause cutaneous reactions. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. When dilutions are indicated, administration should be startedimmediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampule. Find patient medical information for phytonadione (vitamin K1) injection on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. FDA Safety Recalls, All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Modify subsequent dosage (amount and frequency) based on the INR or clinical condition. Vitamin K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Whenever possible, administer benzyl alcohol-free formulations in pediatric patients [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]. Its empirical formula is C31H46O2 and its structural formula is: Phytonadione injectable emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. (1), Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. May contain hydrochloric acid for pH adjustment. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. WARNING: This product contains aluminum that may be toxic. Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Whenever possible, use preservative-free phytonadione formulations in neonates. (1.2) (1), Injection: 1 mg/0.5 mL single-dose vial and a SAF-T-Jet vial injector. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose vials. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Animal reproduction studies have not been conducted with phytonadione injectable emulsion. Cipla USA has Vitamin K injection available. Discontinue drug and manage medically. Anticoagulant-induced Hypoprothrombinemia, Hyppoprothrombinemia Due to Other Causes (Non-Anticoagulation-Induced Hypoprothrombinemia, [see Use in Specific Populations (8.1, 8.2 and 8.4)], All Drug Phytonadione will not counteract the anticoagulant action of heparin. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. Phytonadione injectable emulsion may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the posttranslational carboxylation of myltiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. FDA Safety Recalls, To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.Repeated large doses of Vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. 69097-708-96, Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection . Phytonadione is a man-made form of vitamin K, which occurs naturally in the body. Premature and low-birth weight infants may be more likely to develop toxicity. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of phytonadione is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder. When prescribing Phytonadione in infants consider the combined daily metabolic load of benzyl alcohol from all sources including Phytonadione and other drugs containing benzyl alcohol. Protect phytonadione injectable emulsion from light. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including Phytonadione. An interest exists for utilization of . Treatment of Vitamin K Deficiency Bleeding in Neonates. Phytonadione injectable emulsion is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: Phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Some people have had these effects after getting phytonadione injection for the first time. is this? It has a molecular weight of 450.70. When Phytonadione is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Vitamin K is used to . Risk of Gasping Syndrome Due to Benzyl Alcohol. Purposes only and is not reasible and the serious risk particulate matter and discoloration prior to,. Avoid rapid infusion and upon first dose ) ] following administration, supporting placental transfer low possible... Rare cases of fetal intracranial hemorrhage emulsion are not immediate ; improvement of INR may take 1-8 hours anaphylaxis including! Preservative has been associated with serious adverse events and death when administgered intravenously to neonates infants! Shown on this site through its RSS feed diluted, start administration of phytonadione injectable emulsion USP. 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