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Nada 110-048

Date of Approval Letter: FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION ALBAZEN (albendazole) ".for the removal and control of a variety of internal parasites common in cattle and sheep." Pfizer, Inc.
General Information INFORMATION
NADA Number: Pfizer, Inc. 235 East 42d Street New York, New York 10017 Established Name: Trade Name: Pharmacological category: antiparasitic How Supplied: 500- and 1000-mL bottles Label claim of the Amount 11.36% suspension (113.6 mg/mL) of Active Ingredient(s): Marketing Status: over-the-counter sheep and cattle Effect of the Supplement: The supplement adds sheep uses approved for a less concentrated suspension to labeling for an approved, more concentrated formulation. II. INDICATIONS FOR USE
For the removal and control of the following parasites in cattle and sheep Parasite
Fasciola hepatica Fasciola hepatica, Fascioloides magna Tapeworms (heads and Moniezia benedeni, M. expansa Common Tapeworms (Moniezia expansa), Fringed Tapeworms (Thysanosoma actinioides) Stomach Worms (adults and Brown Stomach Worms, Brown Stomach Worms 4th stage larvae) including 4th stage inhibited (Ostertagia circumcincta, larvae (Ostertagia ostertagi), Marshallagia marshalli), Barberpole Worms Barberpole Worms (Haemonchus (Haemonchus contortus, contortus), Small Stomach H. placei), Small Stomach Worms (Trichostrongylus axei) Worms (Trichostrongylus axei) Intestinal Worms (adults and Thread-Necked Intestinal Thread-Necked Intestinal 4th stage larvae) Worms (Nematodirus Worms (Nematodirus spathiger, N. helvetianus), spathiger, N. filicollis ), Small Intestinal Worms Cooper's Worm (Cooperia (Cooperia oncophora, oncophora), Bankrupt Worms C. punctata) colubriformis), Nodular Worms (Oesophagostomum columbianum), Large-Mouth Bowel Worms (Chabertia ovina) Intestinal Worms (adults and Hookworms (Bunostomum 4th stage larvae) phlebotomum), Bankrupt Worms (Trichostrongylus colubriformis),Nodular Worms (Oesophagostomum radiatum) Lungworms (adults and 4th stage Dictyocaulus viviparus larvae) Lungworms (adults and larval Dictyocaulus filaria III. DOSAGE FORM, ROUTE OF ADMINISTRATION, AND DOSAGE
A. Dosage Form: suspension B. Route of Administration: oral, as a drench C. Recommended Dosage: 7.5 mg/kg body weight (3.4 mg/lb; sheep) or 10 mg/kg body weight (4.45 mg/lb; cattle). IV. TARGET ANIMAL SAFETY AND EFFECTIVENESS
Target animal safety and effectiveness data for albendazole in sheep and cattle were accepted under original NADA 140-934 & NADA 110-048. The increased albendazole concentration is not expected to pose any specific risk hazard to sheep. The actual amount of drug administered to sheep per unit body weight remains unchanged. CVM has concluded that the two formulations should perform in an identical manner when administered to sheep. Accordingly, the sponsor's request for waiver of in vivo study requirement has been granted, and no additional studies are required to support the approval of the 11.36% oral suspension of albendazole for sheep.
This supplemental NADA did not require new human safety studies. The basic toxicology and residue chemistry studies that support the use of albendazole in cattle and sheep are summarized in the FOI Summaries for the original approvals of albendazole under NADA 110-048 and NADA 140-934. Based on the original NADAs, the following has been assigned to this product: a. Acceptable Daily Intake: The Acceptable Daily Intake (ADI) of 5 µg/kg body weight/day was assigned to cattle and sheep on the basis of the toxicology studies. b. Safe Concentrations of Residues: The safe concentrations of albendazole residues in edible tissues of sheep and cattle were established at 0.6 part per million (ppm) for sheep and cattle muscle, 3.0 ppm for liver, kidney and fat tissue of sheep, 1.2 ppm for cattle liver, 1.8 ppm for cattle kidney, and 2.4 ppm for cattle fat. c. Tolerances of Marker Residue: Residue and metabolism studies established 0.2 ppm and 0.25 ppm as the tolerances for residues of albendazole 2-aminosulfone (the marker residue) in cattle liver (target tissue) and sheep liver, respectively. d. Assignment of a muscle tolerance: A tolerance of 0.05 ppm albendazole 2-aminosulfone is assigned for cattle and sheep muscle following a review of the residue studies conducted with albendazole in those species. The total residue studies conducted with 14C-albendazole show that total residues in muscle are expected to be in the range of 1 ppm to 4 ppm at 1 day after dosing under the approved conditions of use and that those residues deplete to 0.06 ppm or less (10% of the 0.6 ppm muscle safe concentration) by 3 to 4 days after dosing. Because of the rapid depletion of total residues from muscle, muscle tissue was not assayed in any of the non-radiolabeled (withdrawal) residue studies in either NADA 110-048 or NADA 140-934. Likewise, the metabolites present in muscle were not profiled. With a minimum of residue data available, the muscle tolerance value is estimated with consideration given to the metabolite profile data in liver of each species and to the capabilities of the determinative analytical method for residues in liver. A concentration of 0.05 ppm of the marker residue is assigned as the muscle tolerance because it represents a conservative estimate of the tolerance, and it is above the 0.025 ppm limit of quantitation of the determinative assay as validated in liver. The 0.05 ppm muscle tolerance makes it possible to identify cattle or sheep that have been marketed within 1 to 3 days after treatment with albendazole. As withdrawal times approaching the preslaughter withdrawal periods of 27 days for cattle and 7 days for sheep, the marker residue is unlikely to be detected in muscle tissue.
The information submitted in support of this application comply with the requirements of Section 512 of the Federal Food, Drug, and Cosmetic Act and implementing regulations at Part 514 of Title 21, Code of Federal Regulations (21 CFR 514) and indicate that albendazole oral suspension (11.36% ) is safe and effective in sheep for the conditions of the use described in labeling. Although no new toxicology or residue chemistry studies were submitted with this supplement, CVM has used this opportunity to assign a tolerance of 0.05 ppm albendazole 2-aminosulfone for residues of albendazole in cattle and sheep muscle. The pre-slaughter withdrawal periods of 27 days in cattle and 7 days in sheep remain unchanged. There is reasonable certainty that the directions for use on labeling can and will be followed in practice. Accordingly, the Agency has concluded that this product shall retain over-the-counter marketing status. In accordance with 21 CFR 514.106(b)(2), this is a category II change which did not require a reevaluation of the safety and effectiveness data in the parent application. The Agency has carefully considered the potential environmental effects of this action and has concluded that the action qualifies for a categorical exclusion from the requirement to prepare an environmental assessment in accordance with 21 CFR 25.33(a)(1). VIII. APPROVED LABELING (attached)
Facsimile label. 1-liter bottle


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Imuno (18) 6 - miolo 4ª prova.indd

ARTIGO DE REVISÃO / REVIEW ARTICLE Data de recepção / Received in: 17/09/2010 Data de aceitação / Accepted for publication in: 10/11/2010 Marta Salgado, Rute Reis, António Vinhas de Sousa, Elza Tomaz, Irina Dydenko, Andreia Ferrão, Fátima Ferreira, Filipe Inácio Serviço de Imunoalergologia / Immunoallergology Department – Hospital de São Bernardo, Setúbal