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Search results with tag "Food and drug"

DOSAGE FORMS AND STRENGTHS - Food and Drug …

DOSAGE FORMS AND STRENGTHS - Food and Drug

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Non-Small Cell Lung Cancer - Combination with Cisplatin (1.1) 09/2008 . Indications and Usage, Locally Advanced or Metastatic Nonsquamous ... 7.1 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 7.2 Nephrotoxic Drugs . 8 USE IN SPECIFIC POPULATIONS . 8.1 Pregnancy . 8.3 Nursing Mothers . 8.4 Pediatric Use . 8.5 Geriatric Use .

  Drug, Food, Food and drug, Anti, Steroidal, Non steroidal anti

(quetiapine fumarate) TABLETS - Food and Drug …

(quetiapine fumarate) TABLETS - Food and Drug

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SEROQUEL is an antagonist at multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2 (IC50s=717 & 148nM respectively), dopamine D1 and D2 (IC50s=1268 & 329nM respectively), histamine H1 (IC50=30nM), and adrenergic α1 and α2 receptors (IC50s=94 & 271nM, respectively). SEROQUEL has no

  Drug, Food, Food and drug, Tablets, Histamine, Quetiapine fumarate, Quetiapine, Fumarate, Receptors

PRESCRIBING INFORMATION PAXIL - Food and Drug …

PRESCRIBING INFORMATION PAXIL - Food and Drug

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PRESCRIBING INFORMATION . PAXIL ® (paroxetine hydrochloride) Tablets and Oral Suspension. Suicidality and Antidepressant Drugs . Antidepressants increased the risk compared to placebo of suicidal thinking and

  Drug, Food, Food and drug

Tobramycin for Injection USP - Food and Drug …

Tobramycin for Injection USP - Food and Drug

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Patients treated with tobramycin for injection USP and other aminoglycosides should be under close clinical 13-14 2 H P. in normal adults. Dosage for such patients must, therefore, be adjusted accordingly and nephrotoxicity renal immaturity and the resulting prolongation of …

  Drug, Food, Food and drug, Injection, Aminoglycoside, Tobramycin, Tobramycin for injection usp

FULL PRESCRIBING INFORMATION - Food and Drug …

FULL PRESCRIBING INFORMATION - Food and Drug

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Warnings and Precaution (5.1) for statement regarding fatal hepatic dysfunction. 2 DOSAGE AND ADMINISTRATION 2.1 Epilepsy Depakene is intended for oral administration. Depakene capsules should be swallowed whole without chewing to avoid local irritation of the mouth and throat. Patients should be informed to take Depakene every day as prescribed.

  Drug, Food, Food and drug

FULL PRESCRIBING INFORMATION - Food and Drug …

FULL PRESCRIBING INFORMATION - Food and Drug

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NDA 020241/S-043 and S-044 NDA 020764/S-036 and S-037 NDA 022251/S-005 and S-006 FDA Approved Labeling Text dated 10/12/2010 Page 4 . 37 . Monotherapy:

  Drug, Food, Food and drug

Draft Guidance on Rivaroxaban - Food and Drug …

Draft Guidance on Rivaroxaban - Food and Drug

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Additional comments: Due to the risk of bleeding, conduct a testing on prothrombin time (PT), activated partial thromboplastin time (aPTT), and creatinine clearance (CrCl). Exclude subjects with PT and aPTT results above the normal range, and the CrCl value less than 50 mL/min.

  Drug, Testing, Food, Food and drug, Tpat

SELZENTRY (MARAVIROC) label - Food and Drug …

SELZENTRY (MARAVIROC) label - Food and Drug

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indolent or residual opportunistic infections (such as infection with Mycobacterium avium, cytomegalovirus, Pneumocystis jirovecii, Mycobacterium tuberculosis, or reactivation of Herpes simplex and Herpes zoster), which may necessitate further evaluation and treatment. 5.4 Potential Risk of Infection

  Drug, Food, Food and drug, Avium, Selzentry

METHOTREXATE TABLETS, USP - Food and Drug …

METHOTREXATE TABLETS, USP - Food and Drug

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polyarthritis partial correction by methotrexate of spleen cell hyporesponsiveness and suppressed IL 2 production. Other laboratories, however, have been unable to demonstrate similar effects. Clarification of methotrexate’s effect on immune activity and its relation to rheumatoid immunopathogenesis await further studies.

  Drug, Food, Food and drug, Tablets, Methotrexate, Spleen, Methotrexate tablets

FULL PRESCRIBING INFORMATION - Food and Drug …

FULL PRESCRIBING INFORMATION - Food and Drug

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JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The initial dosage for JYNARQUE is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later.

  Information, Drug, Food, Disease, Food and drug, Prescribing, Full, Kidney, Polycystic, Full prescribing information, Polycystic kidney disease

VENTANA PD-L1 (SP142) Assay - Food and Drug …

VENTANA PD-L1 (SP142) Assay - Food and Drug

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VENTANA PD-L1 (SP142) Assay is an immunohistochemical assay utilizing an anti-PD-L1 rabbit monoclonal primary antibody to recognize the programmed death ligand 1 (PD-L1) protein. This assay was co-developed by Roche/Ventana Medical Systems, Inc. (Ventana) and Roche/Genentech to identify patients who are most likely to respond to treatment with

  Drug, Food, Food and drug, Assay, Ventana, Ventana pd l1, Sp142

Amlodipine Besylate Tablets - Food and Drug …

Amlodipine Besylate Tablets - Food and Drug

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Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In …

  Drug, Food, Food and drug, Tablets, Amlodipine, Besylate, Amlodipine besylate, Amlodipine besylate tablets

TIKOSYN (dofetilide) Capsules - Food and Drug …

TIKOSYN (dofetilide) Capsules - Food and Drug

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N H 3 C O NHSO 2 CH 3 DESCRIPTION TIKOSYN ® (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C. 19. H. 27. N. 3. O. 5. S. 2 . and it has a molecular weight of . 441.6. The structural formula is The chemical name for dofetilide is: N

  Drug, Food, Food and drug, Capsule, Tikosyn, Dofetilide

PRESERVATIVE FREE SOLUTION - Food and Drug …

PRESERVATIVE FREE SOLUTION - Food and Drug

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Vinca rosea . Linn). Originally known as leurocristine, it has also been referred to as LCR and VCR. The molecular formula for Vincristine Sulfate, USP is C. 46. H. 56. N. 4. O. 10 •H. 2. SO. 4. It has a molecular weight of . 923.04. The structural formula is as follows: Vincristine Sulfate, USP is a white to off–white powder.

  Drug, Food, Food and drug, Nicva

Ointment 0.03% Ointment 0.1% - Food and Drug …

Ointment 0.03% Ointment 0.1% - Food and Drug

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primarily the cytochrome P-450 system (CYP3A). A metabolic pathway leading to the formation of 8 possible metabolites has been proposed. Demethylation and hydroxylation were identified as the primary mechanisms of biotransformation in vitro. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus.

  Drug, Food, Food and drug, Cytochromes, Cytochrome p 450

Singulair (Montelukast Sodium) - Food and Drug …

Singulair (Montelukast Sodium) - Food and Drug

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The plasma concentration profile of montelukast following administration of the 10-mg film-coated tablet is similar in adolescents ≥15 years of age and young adults. The 10-mg film-coated tablet is recommended for use in patients ≥15 years of age.

  Drug, Food, Food and drug, Sodium, Concentrations, Montelukast, Montelukast sodium

LOESTRIN 1/20 LOESTRIN 1.5/30 - Food and Drug …

LOESTRIN 1/20 LOESTRIN 1.5/30 - Food and Drug

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The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped (8). A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been

  Drug, Food, Disease, Food and drug, Thromboembolic, Loestrin, Thromboembolic disease

Micra™ Transcatheter Pacemaker - Food and Drug …

Micra™ Transcatheter Pacemaker - Food and Drug

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People often have questions about resuming sexual relations after receiving a pacemaker. Most people resume sexual activity, based on their doctor’s guidance. You and your partner should be able to enjoy all the benefits of intimacy.

  Drug, Food, Sexual, Food and drug, Intimacy

Sodium Chloride Injection, USP - Food and Drug …

Sodium Chloride Injection, USP - Food and Drug

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Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known ... sufficient numbers of subjects aged 65 and over to determine whether ... Additives may be incompatible. To add medication before solution administration 1. Prepare medication site.

  Drug, Food, Food and drug, Animal, Number, Additives

VALPROATE SODIUM INJECTION - Food and Drug …

VALPROATE SODIUM INJECTION - Food and Drug

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another stabilized antiepileptic drug [carbamazepine (n = 15), phenytoin (n = 11), or phenobarbital (n = 1)], showed comparable plasma levels for valproic acid when switching from oral DEPAKOTE to IV valproate (1-hour infusion). Eleven healthy volunteers were given single infusions of 1000 mg IV valproate over 5,

  Drug, Food, Food and drug, Antiepileptic, Antiepileptic drug

Promacta (eltrombopag) tablets - Food and Drug …

Promacta (eltrombopag) tablets - Food and Drug

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PROMACTA is a thrombopoietin receptor agonist and TPO-receptor agonists increase the risk for development or progression of reticulin fiber deposition within the bone marrow. Monitor peripheral blood for signs of marrow fibrosis. (5.2) • Discontinuation may result in worsened thrombocytopenia than was present prior to therapy.

  Drug, Food, Food and drug, Agonist

Axonics Patient Therapy Guide - Food and Drug …

Axonics Patient Therapy Guide - Food and Drug

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therapy from an external Trial Stimulator at home. A diary of your symptoms will be captured before and during your test stimulation period. This will help your doctor determine if you benefit from the therapy. Your doctor will use the results of your test stimulation period to determine if you should get the full implanted Axonics SNM System.

  Drug, Food, Food and drug, Therapy

Sodium Chloride Injection, USP - Food and Drug …

Sodium Chloride Injection, USP - Food and Drug

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Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.5 (4.5 to 7.0). Composition,

  Drug, Food, Food and drug, Sodium

PRESCRIBING INFORMATION ZOVIRAX - Food and Drug …

PRESCRIBING INFORMATION ZOVIRAX - Food and Drug

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Recurrent Genital Herpes: Double-blind, placebo-controlled studies in patients with frequent recurrences (6 or more episodes per year) have shown that orally administered ZOVIRAX given daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in greater than 95% of patients.

  Information, Drug, Food, Food and drug, Prescribing, Prescribing information, Double

(GEMCITABINE HCl) FOR INJECTION - Food and Drug …

(GEMCITABINE HCl) FOR INJECTION - Food and Drug

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the Gemzar plus cisplatin arm was 5.0 months compared to 4.1 months on the etoposide plus cisplatin arm (Logrank p=0.015, two-sided). The objective response rate for the Gemzar plus cisplatin arm was 33% compared to 14% on the etoposide plus cisplatin arm (Fisher’s Exact

  Drug, Food, Food and drug, Injection, For injection, Gemcitabine, Etoposide, Gemcitabine hcl

PATIENT INFORMATION BROCHURE - Food and Drug …

PATIENT INFORMATION BROCHURE - Food and Drug

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BROCHURE AcrySof™ IQ Vivity™ Extended Vision IOL Models DFT015, DAT015 AcrySof™ IQ Vivity™ Toric Extended Vision IOL Models DFT315, DFT415, DFT515, DAT315, DAT415, DAT515 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 …

  Information, Patients, Drug, Food, Food and drug, Brochure, Patient information brochure

STIVARGA (regorafenib) Label - Food and Drug …

STIVARGA (regorafenib) Label - Food and Drug

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• For Grade 3 aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) elevation; only resume if the potential benefit outweighs the risk of hepatotoxicity Reduce the dose of Stivarga to 80 mg: • For re-occurrence of Grade 2 HFSR at the 120 mg dose

  Drug, Food, Food and drug, Alanine, Aminotransferase, Alanine aminotransferase

Fentanyl Citrate Injection, USP - Food and Drug …

Fentanyl Citrate Injection, USP - Food and Drug

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Fentanyl Citrate Injection, USP is a potent o p i o i d ag o nis t . Each milliliter of solution contains fentanyl citrate equivalent to 50 mcg of fentanyl base, adjusted to pH 4.0 to 7.5 with sodium hydroxide. Fentanyl citrate is

  Drug, Food, Food and drug, Injection, Fentanyl, Citrate, Fentanyl citrate injection, Fentanyl citrate

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