Pfizer Hospital USVITAMIN K1- phytonadione injection, emulsion Hospira, Inc. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- VITAMIN K1 INJECTIONPhytonadioneEmulsión injection, USP Aqueous dispersal of vitamin K1 Ampul Rx only Protects from the light. Keep the ampules in tray until the time of use. ADMINISTRATION - INTRAVENTIVE AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after the INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute phytonadione and prevent rapid infusion. Serious reactions, including deaths, have also been reported following the administration of INTRAMUSCULAR. Typically these severe reactions have appeared to be hypersensitivity or anaphylaxis, including heart and/or respiratory shock and strike. Some patients have exhibited these severe reactions by receiving phyto-dione for the first time. Therefore, the routes INTRAVENOUS and INTRAMUSCULAR should be limited to situations where the subcutaneous route is not feasible and the serious risk involved is considered justified. DESCRIPTION Photonadione is a vitamin, which is a clear liquid, yellow to amber, viscous, toilet or almost toilet. It is water-soluble, soluble in chloroform and slightly soluble in ethanol. He's got a molecular weight of 450.70. Photonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is: Injection of vitamin K1 (Injectable pitonadiona emulsion, USP) is a yellow, sterile, non-pyrogenic aqueous dispersion available for injection by intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadiona 2 or 10 mg, derivative polyoxylated fatty acid 70 mg, dextrose, hydrous 37.5 mg in injection water; alcohol bencil 9 mg added as preservative. It may contain chloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Photonadione is oxygen sensitive. PHARMACOLOGYVitamin K1 Injection (Phytonadione Injectable Emulsion, USP) aqueous vitamin K1 dispersion for parenteral injection, possesses the same type and degree of activity as naturally-acquired vitamin K, necessary for production through the active protrombin liver (factor II), plasma proconverin (factor VII), component IX is sensitive to protrombin. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes post-translational carboxylation of multiple glutamine residues, specific, with peptide limits in inactive liver precursors of factors II, VII, IX and X. Gamma-carboxy-glutamic acid residues convert precursors into active coagulation factors that are later secreted by liver cells in the blood. Photonadione is easily absorbed after intramuscular administration. After absorption, phytonadiona initially concentrates on the liver, but concentration decreases rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic destiny of vitamin K. Almost no free vitamin K without metabolized appears in bile or urine. In normal animals and humans, phytonadiona is practically devoid of pharmacodynamic activity. However, in vitamin K-deficient animals and humans, the pharmacological action of vitamin K is related to its normal physiological function, i.e. to promote liver biosynthesis of vitamin K-dependent coagulation factors. The action of aqueous dispersal, when administered intravenously, is usually detectable within an hour or two and the bleeding is usually controlled within 3 to 6 hours. A normal level of protrombin can often be obtained in 12 to 14 hours. In the prophylaxis and treatment of newborn hemorrhagic disease, phytoonadione has shown a greater safety margin than that of water-soluble vitamin K analogues. INDICATIONS AND USAGEVitamin K1 Injection (Emulsion injectable of hydrotonadion, USP) is indicated in the following coagulation disorders that are due to the defective formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference in the activity of vitamin K. Vitamin K1 Injection is indicated in: protrombin deficiency induced by anticoagulants caused by coumarin or derivatives indanediones;prophylaxis and therapy of the hemorrhagic disease of the newborn; hypotrombinemia hypoprotrombinemia due to antibacterial therapy; hypoprotrombinemia secondary to factors that limit the absorption or synthesis of vitamin K, for example fibrosis WARNINGSThe bencillin alcohol as a preservative in the injection of bacteriostatic sodium chloride has been associated with toxicity in newborns. Data are not available on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in vitamin K1 injection (Pytonadion injectable emulsion, USP), when used as recommended, is associated with toxicity. An immediate coagulative effect should not be expected after the administration of phytonadione. It takes a minimum of 1 to 2 hours for a measurable improvement in protrombin time. Total blood or component therapy may also be necessary if the bleeding is severe. The Fitonadiona will not counteract the anticoagulant action of the heparin. When vitamin K1 is used to correct hypoprotrombinemia induced by excessive anticoagulants, anticoagulant therapy continues to be indicated, the patient faces again the existing coagulation risks before initiating anticoagulant therapy. Photonadione is not a coagulation agent, but excessive therapy with vitamin K1 can restore the conditions that originally allowed thromboembolic phenomena. The dose should be kept as low as possible, and protrombin time should be checked regularly as clinical conditions indicate. Repeated large doses of vitamin K are not justified in liver disease if the response to the initial use of vitamin is unsatisfactory. The lack of response to vitamin K may indicate that the condition being treated is inherently inresponsible to vitamin K.Bencilin alcohol has been reported to be associated with a fatal "gast syndrome" in premature babies. Warning: This product contains aluminum that can be toxic. Aluminum can reach toxic levels with extended parenteral management if the kidney function deteriorates. Premature neonates are particularly at risk because their kidneys are immature, and require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with poor kidney function, including premature neonates, who receive kineal levels of aluminum at more than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with the central nervous system and bone toxicity. The tissue load can occur at even lower management rates. PRECAUTIONS Drug Interactions Temporary resistance to protrombient depressive anticoagulants may result, especially when larger doses of phytodine are used. If relatively large doses have been used, anticoagulant therapy may be necessary to use somewhat larger doses of protrombino-depressant anticoagulant, or to use one that acts in a different principle, such as heparin sodium. Laboratory tests Protrombin time should be regularly reviewed as clinical conditions indicate. Carcinogenesis, Mutagenesis, Fertility ImpermeabilityCarcinogenicity studies, mutagenesis or fertility impairment have not been performed with vitamin K1 injection (Seponadiona injection, USP). Pregnancy Animal reproduction studies have not been performed with vitamin K1 injection. Nor is it known whether vitamin K1 injection can cause fetal damage when given to a pregnant woman or may affect the reproductive capacity. Injection of vitamin K1 should be given to a pregnant woman only if clearly necessary. Mothers of Nursing It is not known if this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the injection of vitamin K1 is given to a woman in nursing. Pediatric useHemolisis, jaundice and hyperbilirubibinemia in neonates, in particular premature ones, may be related to the injection dose of vitamin K1. Therefore, the recommended dose should not exceed (See and ). REACTIONS Deaths have occurred after intravenous and intramuscular administration. (See .)Transient feelings of "flushing" and "peculiar" of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, short hypotension, dyspnea and cyanosis. Pain, swelling, and tenderness at the injection site may occur. Consideration should be given to the possibility of allergic sensitivity, including an anaphylactoid reaction. Infrequently, usually after repeated injection, there have been erythematous, indurate and pruritus plates; they have rarely progressed to lesions such as scleroderma that have persisted for long periods. In other cases, these lesions have resembled to erythema. Hyperbilirubinemia has been observed in the newborn after the administration of phytonadione. This has rarely occurred and mainly with doses above recommended (See , ). OVERDOSAGEIntravenous vitamin injection LD50 K1 (hydrotonadion injectable emulsion, USP) in the mouse is 41.5 and 52 mL/kg for concentrations of 0.2% and 1%, respectively. DOSAGE AND ADMINISTRATION Whenever possible, the injection of vitamin K1 (pitonadion injectable emulsion, USP) must be given by the subcutaneous route (see ). When intravenous administration is considered inevitable, the medication should be injected very slowly, not exceeding 1 mg per minute. Protects from the light at all times. Pharmaceutical products for parenteral should be visually inspected for particle matter and discoloration before administration, provided the solution and containers permit. Directions for Dilution Vitamin K1 Injection can be diluted with chloride injection of 0.9%, dextrose injection of 5%, or dextrose and sodium chloride injection of 5%. Bencillin alcohol as a preservative has been associated with toxicity in newborns. Therefore, all previous dilutes must be free of preservatives (See ). Other dilutes should not be used. When dilutions are indicated, the administration must begin immediately after the mixture with the tooth, and the unused parts of the dilution must be discarded, as well as the unused contents of the ampul. Prophylaxis of the newborn's disease The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of vitamin injection K1 0.5 to 1 mg is recommended within one hour of birth. Treatment of Hemorrhagic Newborn Disease The empirical administration of vitamin K1 should not replace the proper evaluation of the lab of the clotting mechanism. A quick response (short of protrombin time in 2 to 4 hours) after the administration of vitamin K1 is usually a diagnosis of newborn hemorrhagic disease, and lack of response indicates another diagnosis or coagulation disorder. Vitamin K1 Injection 1 mg should be given subcutaneously or intramuscularly. The upper doses may be necessary if the mother has been receiving oral anticoagulants. Total blood or component treatment may be indicated if the bleeding is excessive. However, this therapy does not correct the underlying disorder and the injection of vitamin K1 should be administered simultaneously. Anticoagulant-Induced Prothrombin Adult Deficiency It is recommended to correct excessively prolonged protrombin time caused by oral anticoagulant therapy: 2.5 to 10 mg or up to 25 mg initially. In rare cases 50 mg may be required. The frequency and number of subsequent doses should be determined by protrombin temporary response or clinical condition (see ). If in 6 to 8 hours after parenteral administration protrombino time has not been successfully shortened, the dose should be repeated. Injection of vitamin K1 (Injectable hydrotonadion emulsion, USP) Summary of dose guidelines (See circular text for details) Newborns Dosage Hemorrhagic disease of newborns Prophylaxis 0.5 to 1 mg of IM within 1 hour of birth Treatment 1 mg SC or IM (The higher doses may be necessary if the mother has been receiving oral anticoagulants) Adults Initial dose Anticoagulant-Induced Protrombin deficiency (caused by coumarin or indanediones) 2.5 mg to 10 mg or up to 25 mg (actually 50 mg) Hipoprotrombinemia Due to other causes (Antibiotics; Salicilates or other drugs; Factors that limit absorption or synthesis) 2.5 mg to 25 mg or more more 50 mg) Newborns Dosage Hemorrhagic disease of newborns Prophylaxis 0.5 to 1 mg of IM within 1 hour of birth Treatment 1 mg SC or IM (The highest doses may be necessary if the mother has been receiving oral anticoagulants) Adults Initial dose Anticoagulant-Induced Protrombin deficiency (caused by coumarin or indanediones)2.5 mg to 10 mg orth to 25 mg (in rare 50 mg) Hipoprotrombinemia Due to other causes (Antibiotics; Salicilates or other drugs; Factors that limit absorption or synthesis)2.5 mg to 25 mg or more (rarely up to 50 mg)In case of shock or excessive blood loss, the use of whole blood or component therapy is indicated. Hypoprotrombinemia Due to other causes in adults A dose of 2.5 to 25 mg or more is recommended (approximately 50 mg), the amount and route of administration depending on the severity of the condition and the response obtained. If possible, it is suggested that the dose of drugs that interfere with coagulation mechanisms (such as salicylates; antibiotics) be interrupted or reduced as an alternative to administering the concurrent injection of vitamin K1. The severity of the clotting disorder should determine whether the immediate administration of vitamin K1 injection is necessary in addition to the discontinued or reduction of interfered drugs. SUPPLIEDVitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is supplied in a package of 25 as follows: Sales UnitConcentration NDC 0409-9157-01 25 ampuls in a package1 mg/0.5 mL(2 mg/mL) NDC 0409-9158-01 25 ampuls in a package10 mg/mL Store at 20 to 25°C (68 to 77°F). [See Room temperature controlled by USP. ] Protects from the light. Keep the ampuls in tray until the time of use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1141-1.0Reviewed: 04/2018PRINCIPAL DISPLAY PANEL - 0.5 mL Label Ampul - RL-71300.5 mLNDC 0409-9157-31Rx onlyVITAMIN K1 Inj.Phytonadione InyectableEmulsion, USP1 mg/0.5 mL Neonatal concentrationContains no more than 100 mcg/L Protects from the light. Hospira, Inc.,Lake Forest, IL 60045 USARL-7130Hospira PRINCIPAL DISPLAY PANEL - 0.5 mL Ampul Tray Label - RL-71290,5 mL Single-dose AmpulRx NDC 0409-9157-50Contains 5 of NDC 0409-9157-31 VITAMIN K1 InjectionPhytonadione Injectable Emulsion, USP1 mg/0,5 mL Neonatal concentration Protect Keep the ampuls in tray until the time of use. For Intramuscular, Subcutaneous or Intravenous (with caution). Each ml contains phytonadiona 2 mg; polyoxylated fatty acid 70 mg; dextrose, hydrous 37.5 mg; alcohol benzyl 9 mg added as preservative. It may contain chloric acid for pH.pH 6.3 adjustment (5.0 to 7.0). Usual dose: See insertion. Shop 20 to 25°C (68 to 77°F). [See Room temperature controlled by USP.] Distributed by Hospira, Inc.,Lake Forest, IL 60045 USAHospiraRL-7129PRINCIPAL PANEL DISPLAY - 1 mL Label Ampul - RL-71261 mL onlyNDC 0409-9158-31VITAMIN K1 Inj.Phytonadione Emulsión injection, USP Protects from the light. Rx onlyRL-7126Dist. de Hospira, Inc.Lake Forest, IL 60045 USAPRINCIPAL DISPLAY PANEL - 1 mL de la etiqueta de tray de Ampul - RL-71251 mL Single-dose AmpulRx NDC 0409-9158-50Contains 5 of NDC 0409-9158-31 VITAMIN K1 InjectionPtonad Keep the ampuls in tray until the time of use. For Intramuscular, Subcutaneous or Intravenous (with caution). Each ml contains phytonadiona 10 mg; polyoxylated fatty acid 70 mg; dextrose, hydrous 37.5 mg; alcohol benzyl 9 mg added as preservative. It may contain chloric acid for pH.pH 6.3 adjustment (5.0 to 7.0). Usual dose: See insertion. Shop 20 to 25°C (68 to 77°F). [See Room temperature controlled by USP.] Distributed by Hospira, Inc.,Lake Forest, IL 60045 USAHospiraRL-7125PRINCIPAL PANEL DISPLAY - 1 mL Label Ampul - RL-7127NDC 0409-9158-11Rx only1 mLVITAMIN K1 Inj.Phytonadione Emulsión injection, US Protects from the light. Hospira, Inc.,Lake Forest, IL 60045 USARL -7127novaplusTM PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Label - RL-71281 mL AmpulRx single doseNDC 0409-9158-55It contains 5 NDC 0409-9158-11 VITAMIN K1 InjectionPhytonadione Injectable emulsion, USP10 mg/mL For Intramuscular, Subcutaneous or Intravenous (precaution). Protects from the light. Keep the ampuls in tray until the time of use. Each ml contains phytonadiona 10 mg; polyoxylated fatty acid 70 mg; dextrose, hydrous 37.5 mg; alcohol benzyl 9 mg added as preservative. It may contain chloric acid for pH.pH 6.3 adjustment (5.0 to 7.0). Usual dose: See insertion. Shop 20 to 25°C (68 to 77°F). [See Room temperature controlled by USP.] Distributed by Hospira, Inc.,Lake Forest, IL 60045 USANovaplus is a Vizient, Inc.novaplusTM registrar RL - 7128 VITAMIN K1 injection of phytoonadione, emulsion Product information Product type DRUGItem Code (Source)NDC:0409-9157 INTRAMUSCULAR Administration Route, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Mode Name of IngredientBases of strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE2 mg at 1 mL Inactive ingredients Name of IngredientForz POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 70 mg in 1 ml DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 37.5 mg at 1 mL WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg at 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) Packing #Item CodePackage DescriptionMarketing Start dateMarketing End date 1NDC:0409-9157-015 at 1 CONTAINER06/22/2005 1NDC:0409-9157-505 in 1 TRAY 1NDC:0409-9157-310.5 mL at 1 AMPULE; Type 0: Not a combination product Marketing information Category Marketing Application Number or Monograph Citation End date ANDAANDA08795406/22/2005 Product information Product type DRUGItem Code (Source)NDC:0409-9157 INTRAMUSCULAR Administration Route, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Mode Name of IngredientBases of strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE2 mg at 1 mL Inactive ingredients Name of IngredientForz POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 70 mg in 1 ml DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 37.5 mg at 1 mL WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg at 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) Packing #Item CodePackage DescriptionMarketing Start dateMarketing End date 1NDC:0409-9157-015 at 1 CONTAINER06/22/2005 1NDC:0409-9157-505 in 1 TRAY 1NDC:0409-9157-310.5 mL at 1 AMPULE; Type 0: Not a combination product Marketing information Category Marketing Application Number or Monograph Citation End date ANDAANDA08795406/22/2005 VITAMIN K1 injection of phytoonadione, emulsion Product information Product type DRUGItem Code (Source)NDC:0409-9158 INTRAMUSCULAR Administration Route, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Mode Name of IngredientBases of strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE10 mg at 1 mL Inactive ingredients Name of IngredientForz POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 70 mg in 1 ml DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 37.5 mg at 1 mL WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg at 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) Packing #Item CodePackage DescriptionMarketing Start dateMarketing End date 1NDC:0409-9158-015 at 1 CONTAINER07/27/2005 1NDC:0409-9158-505 in 1 TRAY 1NDC:0409-9158-311 mL at 1 AMPULE; Type 0: Not a combination product 2NDC:0409-9158-255 at 1 CONTAINER01/15/2021 2NDC:0409-9158-555 at 1 TRAY 2NDC:0409-9158-111 mL at 1 AMPULE; Type 0: Not a combination product Marketing information Category Marketing Application Number or Monograph Citation End date ANDAANDA08795507/27/2005 Product information Product type DRUGItem Code (Source)NDC:0409-9158 INTRAMUSCULAR Administration Route, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Mode Name of IngredientBases of strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE10 mg at 1 mL Inactive ingredients Name of IngredientForz POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 70 mg in 1 ml DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 37.5 mg at 1 mL WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg at 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) Packing #Item CodePackage DescriptionMarketing Start dateMarketing End date 1NDC:0409-9158-015 at 1 CONTAINER07/27/2005 1NDC:0409-9158-505 in 1 TRAY 1NDC:0409-9158-311 mL at 1 AMPULE; Type 0: Not a combination product 2NDC:0409-9158-255 at 1 CONTAINER01/15/2021 2NDC:0409-9158-555 at 1 TRAY 2NDC:0409-9158-111 mL at 1 AMPULE; Type 0: Not a combination product Marketing information Category Marketing Application Number or Monograph Citation End date ANDAANDA08795507/27/2005 Labeler - Hospira, Inc. (141588017) Establishment NameAddressID/FEIBusiness Operations Hospira, Inc.093132819ANALYSIS(0409-9157, 0409-9158) , MANUFACTURE(0409-9157, 0409-9158) , PACK(0409-9157, 0409-9158) , LABEL(0409-9157, 0409-9158) Establishment NameAddressID/FEIBusiness Operations Hospira, Inc.827731089ANALYSIS(0409-9157, 0409-9158) Establishment NameAddressID/FEIBusiness Operations DSM Nutritional Products AG Zweigniederlassung Werk Sisseln482688756ANALYSIS(0409-9157, 0409-9158) , API MANUFACTURE(0409-9157, 0409-9158) Establishment NameAddressID/FEIBusiness Operations Hospira, Inc.0306222ANALYSIS(0409-9157, 0409-9158)
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