Injectable products single-dose

Parenteral preparations are filled into various types of containers, depending on the nature of the product. Single-dose injections are filled into glass ampoules sealed by fusion or ex tempore into plastic syringes. Multidose injections are delivered in glass vials sealed with rubber closures with mechanical properties suitable for multiple piercing. Concentrates and powders for injections or infusions are also... 

Most injections are formulated as aqueous solutions, with Water for Injections BP as the vehicle. The formulation of injections depends upon several factors, namely the aqueous solubility of the active ingredient, the dose to be employed, thermal stability of the solution, the route of injection and whether the product is to be prepared as a multidose one (i.e. with a dose or doses removed on different occasions) or in a singledose form (as the term suggests, only one dose is contained in the injection). Nowadays, most injections are prepared as single-dose forms and this is mandatory for certain routes, e.g. spinal injections such as the intrathecal route and large-volume intravenous infusions (section 2.2). Multidose injections may require the inclusion of a suitable... 

There are many circumstances when a single-dose intravenous (IV) study can provide useful information for example, if the intended treatment route is intraper-itoneal (i.p.), or if the product will be administered to an open wound or injected into a muscle or a tumor, it might accidentally enter a blood vessel, and the knowledge gained from an IV study would be of value as well as one by the clinical route. Hence, if the intended clinical route is not IV, the absence of an additional study with IV dosing would require specific justification. 

Required by Austrian Regulatory Authorities for injectable products, life - lifetime Single-single dose only — inappropriate or no experience. 

Dosage form ReFacto is a sterile lyophifized powder for injection available in nominal dosage strengths of 250, 500, and 1000 international units (lU) per vial. Recombinate is formulated as a sterile lyophifized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500, and 1000 lU per bottle. The final product contains an insufficient quantity of von Willebrand Factor to have any clinically effect in patients with von Willebrand s disease. 

Inhibition of immune hemolysis by berberine was described by Tanaka (505). Subcutaneous or intravenous injections of berberine either in single doses or repeatedly did not affect the number of erythrocytes, leukocytes, and the hemoglobin level of intact rabbits (506). In rabbits, with anemia induced by phenylhydrazine and toluenedia-mine, berberine had an antianemic effect. Hasegawa and Tanaka (507) did not observe any effect of berberine on the production of plasma cells. It decreased the anticoagulant action of heparin in dog and human blood in vitro (508). Morthland (509) carried out a spectrophotometric study of the interaction of nucleic acids with aminoacridine or with other basic stains including berberine. 

Single-dose injections are usually packed in glass ampoules containing 1,2 or 5 ml of product. To ensure removal of the correct dose-volume by syringe and needle, it is necessary to add an appropriate overage to the ampoule. Thus a 1-ml ampoule will actually contain 1.1 ml of product and a 2-ml ampoule should contain 2.15 ml of product. 

Tc-CEA-Scan injection is a clear, colorless solution suitable for intravenous injection, used as a single dose (740-1100 MBq resp., 20-30 mCi). The total volume is 2 ml. The pH of the injection solution is 5.0-7.0. The injection solution should be inspected visually for particulate matter and discoloration. If either is present, the product should be discarded (Immunomedics Europe 2000). 

Large Volume Parenterals A sterile single dose injectable product intended for administration through the skin with a nominal fill volume of more than 100ml. It may be packed in glass or suitable plastic material. 

The synthesis of arsphenamine was reported by Ehrlich and Bertheim (1912) and it was patented and then manufactured by the firm, Hoechst (DRP 224 953), and sold by them under the name Salvarsan . The initial announcement of a cure for syphilis was taken up by the newspapers, and Ehrlich became a world celebrity overnight. This fame gave him little pleasure, for he had worries that arose from the discovery. For example, arsphenamine was oxidized in the air to a more toxic product, now known to be oxophenarsine 6.4) a much more selective and desirable drug, and one that would in time replace arsphenamine (see Section 6.2). However, at that time, the uncontrolled oxidations were causing deaths, so that Ehrlich decided that arsphenamine must be issued only as single doses, and in sealed tubes from which all oxygen had been removed. He also issued directions for the preparation of solutions in sterile distilled water, neutralization, and intravenous injection without delay. These directions were often departed from, and the resulting disasters attracted unfortunate publicity. Ehrlich later introduced neoarsphenamine ( 914 ), a more soluble derivative. 

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