Cd

Each 0.5 mL contains 7.5-mcg dose conjugated to approximately 125 meg of outer membrane protein o complex, 5 meg of HBsAg, approximately 225 meg of aluminum as amorphous aluminum (§

hydroxyphosphate sulfate, and 35 meg of sodium borate (decahydrate) as a pH stabilizer, in 0.9% 01

sodium chloride. The vaccine contains not more than 0.0004% (w/v) residual formaldehyde.

Each 0.5 mL of the vaccine consists of 10 meg of hepatitis B surface antigen adsorbed on 0.25 mg of aluminum as aluminum hydroxide with a trace amount of thimerosal (<0.5 meg of mercury) from the manufacturing process, sodium chloride (9 mg/mL), and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL). Each 1-mL adult dose consists of 20 meg of hepatitis B surface antigen adsorbed on 0.5 mg of aluminum as aluminum hydroxide. The adult vaccine is formulated without preservatives. The adult formulation contains a trace amount of thimerosal (<1.0 meg of mercury) from the manufacturing process, sodium chloride (9 mg/mL), and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).

Each milliliter contains 100 IU (3.6378 mg) of insulin glargine, 30 meg of zinc, 2.7 mg of m-cresol, 20 mg of glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide and has a pH of approximately 4.

Product

Composition

Imiglucerase is an analog of the human enzyme, (beta)-glucocerebrosidase, a monomeric glycoprotein of 497 amino acids, containing four /V-linked glycosylation sites (MW = 60,430).

Infliximab is a chimeric lgG1 k MAb with an approximate MW of 149,100 Da. It is composed of human constant and murine variable regions.

Insulin aspart (rDNA origin) homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 with the empirical formula C256H381N65079S6 and a MW of 5825.8.

Insulin glulisine (rDNA origin) differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Chemically, it is 3B-lysine-29B-glutamic acid-human insulin, and has the empirical formula C258H384N64078S6 and a MW of 5823.

Insulin lispro (rDNA origin) is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B-chain are reversed. It has the empirical formula C257H383N65077S6 and a MW of 5808, both identical to that of human insulin.

Interferon alpha-2a contains 165 amino acids, and it has an approximate MW of 19,000 Da.

Each vial contains imiglucerase (212 units), mannitol (170 mg), sodium citrates (70 mg), trisodium citrate (52 mg), disodium hydrogen citrate (18 mg), polysorbate 80 (0.53 mg). Citric acid and/or sodium hydroxide may have been added at the time of manufacture to adjust pH. Haemaccel® (cross-linked gelatin polypeptides) is used as a stabilizing agent.

Each single-use vial contains 100 mg of infliximab, 500 mg of sucrose, 0.5 mg of polysorbate 80, 2.2 mg of monobasic sodium phosphate, monohydrate, and 6.1 mg of dibasic sodium phosphate, dihydrate. No preservatives are present.

Each milliliter contains insulin aspart (B28 asp regular human insulin analog), 100 units/mL, glycerin (16 mg/mL), phenol (1.50 mg/mL), metacresol (1.72 mg/mL), zinc (19.6 |j,g/mL), disodium hydrogen phosphate dihydrate (1.25 mg/mL), and sodium chloride (0.58 mg/mL). It has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

Each milliliter of APIDRA (insulin glulisine injection) contains 100 lU (3.49 mg) of insulin glulisine, 3.15 mg of m-cresol, 6 mg of tromethamine, 5 mg of sodium chloride, 0.01 mg of polysorbate 20, and water for injection.

Each milliliter contains insulin lispro 100 units, 16 mg of glycerin, 1.88 mg of dibasic sodium phosphate, 3.15 mg of m-cresol, zinc oxide content adjusted to provide 0.0197 mg of zinc ion, trace amounts of phenol, and water for injection. Insulin lispro has a pH of 7.0-7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

Each milliliter contains 3 MIU of interferon alpha-2a, recombinant, 7.21 mg of sodium chloride, 0.2 mg of polysorbate 80, 10 mg of benzyl alcohol as a preservative, and 0.77 mg of ammonium acetate.

Interferon alpha-2b has a MW of 19,271 Da.

Interferon alphacon-1 has a 166-amino acid sequence and differs from interferon alpha-2b at 20/166 amino acids (88% homology), and comparison with interferon-beta shows identity over 30% of the amino acid positions and has a MW of 19,434 Da.

Interferon beta-1a is a 166-amino acid glycoprotein with a MW of approximately 22,500 Da.

Interferon beta-1a is a 166-amino acid glycoprotein with a predicted MW of approximately 22,500 Da.

Interferon beta-1b is a protein that has 165 amino acids and an approximate MW of 18,500 Da. It does not include the carbohydrate side-chains found in the natural material.

Interferon gamma-1b is a single-chain polypeptide containing 140 amino acids consisting of noncovalent dimers of two identical 16,465-Da monomers.

Interleukin eleven (IL-11) is a thrombopoietic growth factor and has a molecular mass of approximately 19,000 Da, and is nonglycosylated. The polypeptide is 177 amino acids in length.

Each milliliter contains 3, 5, 18, 25, or 50 MIU and also contains 20 mg of glycine, 2.3 mg of sodium phosphate dibasic, 0.55 mg of sodium phosphate monobasic, and 1.0 mg of human albumin after reconstitution. The solution formulation contains besides the active drug, 7.5 mg of sodium chloride, 1.8 mg of sodium phosphate dibasic, 1.3 mg of sodium phosphate monobasic, 0.1 mg of edetate disodium, 0.1 mg of polysorbate 80, and 1.5 mg of m-cresol as a preservative. The multidose preparations also contain 1.5 mg of cresol as preservative.

Each vial and prefilled syringe contains 0.03 mg/mL of interferon alphacon-1, 5.9 mg/mL of sodium chloride, and 3.8 mg/mL of sodium phosphate in water for injection, USP.

Each 0.5 ml contains either 44 meg or 22 meg of interferon beta-1a, 4 or 2 mg of albumin (human) USP, 27.3 mg of mannitol USP, 0.4 mg of sodium acetate, and water for injection, USP.

Each 1.0 mL (1.0 cc) of reconstituted solution contains 30 meg of interferon beta-1 a, 15 mg of albumin (human), USP, 5.8 mg of sodium chloride, USP, 5.7 mg of dibasic sodium phosphate, USP, and 1.2 mg of monobasic sodium phosphate, USP, at a pH of approximately 7.3.

Dextrose and albumin (human), USP (15 mg each/vial) are added as stabilizers. Lyophilized Betaseron is a sterile, white to off-white powder intended for subcutaneous injection after reconstitution with the diluent supplied (sodium chloride, 0.54% solution).

Each 0.5 mL contains: 100 meg (two million IU) of interferon gamma-1 b formulated in 20 mg of mannitol, 0.36 mg of sodium succinate, 0.05 mg of polysorbate 20, and SWFI.

Each vial contains 5 mg of IL-11 with 23 mg of glycine, USP, 1.6 mg of dibasic sodium phosphate heptahydrate, USP, and 0.55 mg of monobasic sodium phosphate monohydrate, USP. When reconstituted with 1 mL of SWFI, USP, the resulting solution has a pH of 7.0 and a concentration of 5 mg/mL.

Product

Composition

Laronidase is a glycoprotein with a MW of approximately 83 kDa. The recombinant protein is comprised of 628 amino acids after cleavage of the /V-terminus and contains six /V-linked oligosaccharide modification sites. Two oligosaccharide chains terminate in mannose-6-phosphate sugars.

Lepirudin (rDNA) is: [Leu1, Thr2]-63-desulfohirudin, a polypeptide composed of 65 amino acids and has a MW of 6979.5 Da.

Muromonab-CD3 is a murine MAb to the CD3 antigen of human T cells. The antibody is a biochemically purified lgG2a immunoglobulin with a heavy chain of approximately 50,000 Da and a light chain of approximately 25,000 Da.

Nesiritide is a hBNP with a MW of 3464 g/mol and an empirical formula of C143H244N50042S4.

Omalizumab is a MAb with a MW of approximately 149 kDa.

Palivizumab is a humanized MAb composed of two heavy chains and two light chains and has a MW of approximately 148,000 Da.

Parathyroid hormone (1-34) has a MW of 4117.8 Da.

Must be diluted prior to administration in 0.9% sodium chloride injection, USP containing 0.1% of albumin (human). The solution in each vial contains a nominal laronidase concentration of 0.58 mg/mL and a pH of approximately 5.5. The extractable volume of 5.0 mL from each vial provides 2.9 mg of laronidase, 43.9 mg of sodium chloride, 63.5 mg of sodium phosphate monobasic monohydrate, 10.7 mg of sodium phosphate dibasic heptahydrate, and 0.05 mg of polysorbate 80.

Each vial contains 50 mg of lepirudin, 40 mg of mannitol and sodium hydroxide for adjustment of pH to approximately 7.

Each ampule contains a buffered solution (pH 7.0 + 0.5) of monobasic sodium phosphate (2.25 mg), dibasic sodium phosphate (9.0 mg), sodium chloride (43 mg), and polysorbate 80 (1.0 mg) in water for injection.

Each 1.5-mg vial contains nesiritide (1.58 mg), mannitol (20.0 mg), citric acid monohydrate (2.1 mg), and sodium citrate dihydrate (2.94 mg).

Each vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg l-histidine hydrochloride monohydrate, 1.8 mg l-histidine, and 0.5 mg polysorbate 20, and is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.

Upon reconstitution, it contains the following excipients: 47 mM of histidine, 3.0 mM of glycine and 5.6% mannitol, and the active ingredient, palivizumab, at a concentration of 100 mg/mL solution.

Each prefilled delivery device is filled with 3.3 mL to deliver 3 mL. Each milliliter contains 250 meg of teriparatide (corrected for acetate, chloride, and water content), 0.41 mg of glacial acetic acid, 0.10 mg of sodium acetate (anhydrous), 45.4 mg of mannitol, 3.0 mg of m-cresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge preassembled into a pen device delivers 20 meg of teriparatide per dose each day for up to 28 days.

Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypoly-ethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a MW of approximately 19 kDa. To produce pegfilgrastim, a 20-kDa monomethoxypolyethylene glycol (PEG) molecule is covalently bound to the /V-terminal methionyl residue of filgrastim. The average MW of pegfilgrastim is approximately 39 kDa.

Peginterferon alpha-2a is a covalent conjugate of recombinant alpha-2a interferon (approximate MW is 20,000 Da) with a single branched d/'s-monomethoxy PEG chain (approximate MW is 40,000 Da). Peginterferon alpha-2a has an approximate MW of 60,000 Da.

Peginterferon alpha-2b is a covalent conjugate of recombinant alpha interferon with monomethoxy PEG. The MW of the PEG portion of the molecule is 12,000 Da. The average MW of the PEG-intron molecule is approximately 31,000 Da.

Pegvisomant is a protein containing 191 amino acid residues to which several PEG polymers are covalently bound (predominantly 4 to 6 PEG/protein molecule). The MW of the protein of pegvisomant is 21,998 Da. The MW of the PEG portion of pegvisomant is approximately 5000 Da. The predominant MWs of pegvisomant are thus approximately 42,000, 47,000, and 52,000 Da.

Each syringe contains 6 mg of pegfilgrastim (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection.

Each vial contains approximately 1.2 mL of solution to deliver 1.0 mL of DP. Subcutaneous administration of 1.0 mL delivers 180 meg of DP (expressed as the amount of interferon alpha-2a), 8.0 mg of sodium chloride, 0.05 mg of polysorbate 80, 10.0 mg of benzyl alcohol, 2.62 mg of sodium acetate trihydrate, and 0.05 mg of acetic acid. The solution is colorless to light yellow and the pH is 6.0 ± 0.01.

Each vial contains either 74, 118.4, 177.6, or 222 (j,g of PEG-intron, and 1.11 mg of dibasic sodium phosphate anhydrous, 1.11 mg of monobasic sodium phosphate dihydrate, 59.2 mg of sucrose, and 0.074 mg of polysorbate 80. Following reconstitution with 0.7 mL of the supplied diluent (SWFI, USP), each vial contains peginterferon at strengths of either 100, 160, 240, or 300 |j.g/mL.

Each vial also contains 1.36 mg of glycine, 36.0 mg of mannitol, 1.04 mg of sodium phosphate dibasic anhydrous, and 0.36 mg of sodium phosphate monobasic monohydrate.

Product

Composition

Rasburicase is a recombinant urate-oxidase enzyme produced by a genetically modified Saccharomyces cerevisiae strain. It is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa. The molecular formula of the monomer is C1523H2383N4170462S7. The monomer, made up of a single 301 amino acid polypeptide chain, has no intra- or interdisulfide bridges and is /V-terminal-acetylated.

Reteplase is a nonglycosylated deletion mutein of tPA, containing the kringle 2 and the protease domains of human tPA. It contains 355 of the 527 amino acids of native tPA (amino acids 1 -3 and 176-527). The MW is 39,571 Da.

Rituximab is a chimeric murine/human MAb composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids.

Sargramostim is a rhu GM-CSF, a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800, and 15,500 Da.

Sermorelin acetate is the acetate salt of an amidated synthetic 29-amino acid peptide (GRF 1 -29 NH2) consisting of 44 amino acid residues. The free base of sermorelin has the empirical formula C 149 H 246 N 44 O 42 S and a MW of 3358 Da.

Each 3-mL vial containing 1.5 mg of rasburicase, 10.6 mg of mannitol, 15.9 mg of l-alanine, and between 12.6 and 14.3 mg of dibasic sodium phosphate. The diluent solution for reconstitution, supplied in a 2-mL clear, glass ampule, is composed of 1.0 mL of SWFI, USP, and 1.0 mg of Poloxamer 188.

Each vial contains 10.4 units (18.1 mg), tranexamic acid (8.32 mg), dipotassium hydrogen phosphate (136.24 mg), phosphoric acid (51.27 mg), sucrose (364 mg), and polysorbate 88 (5.2 mg).

The product is formulated for intravenous administration in 9.0 mg/mL of sodium chloride, 7.35 mg/mL of sodium citrate dihydrate, 0.7 mg/mL of polysorbate 80, and SWFI. The pH is adjusted to 6.5.

Liquid formulation contains 500 meg (2.8 x 106 lU/mL) of sargramostim and 1.1% benzyl alcohol in 1 mL solution. Lyophilized vial contains 25 meg (1.4 x 106 IU/vial) of sargramostim. Both contain 40 mg/mL of mannitol, 10 mg/mL of sucrose, and 1.2 mg/mL of tromethamine.

Each vial contains 0.5 mg of sermorelin (as the acetate) and 5 mg of mannitol. The pH is adjusted with dibasic sodium phosphate and monobasic sodium phosphate buffer. Each 1.0-mL vial contains 1.0 mg of sermorelin (as the acetate) and 5 mg of mannitol. The pH is adjusted with dibasic sodium phosphate and monobasic sodium phosphate buffer.

Somatropin (rDNA origin) is a polypeptide hormone of rDNA origin. It has 191 amino acid residues and a MW of 22,124 Da.

Tenecteplase is a 527-amino acid glycoprotein.

Thyrotropin alpha is a heterodimeric glycoprotein comprised of two noncovalently linked subunits, an alpha subunit of 92 amino acid residues containing two /V-linked glycosylation sites and a beta subunit of 118 residues containing one /V-linked glycosylation site.

Tositumomab and iodine l131 Tositumomab. Tositumomab is composed of two murine gamma 2a heavy chains of 451 amino acids each and two lambda light chains of 220 amino acids each. The approximate MW of Tositumomab is 150 kDa.

Trastuzumab is a rDNA-derived humanized MAb, an lgG1 kappa that contains human framework regions with the complementarity-determining regions of a murine antibody (4D5) that binds to HER2.

A dose of 1.5 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin (1.5 mg) (approximately 4.5 IU), glycine (27.6 mg), sodium dihydrogen phosphate anhydrous (0.3 mg), anddisodium phosphate anhydrous (0.3 mg); the rear chamber contains 1,13-mL water for injection. The 5.8-mg dose system has in the rear chamber 0.3% m-cresol (as a preservative) and mannitol, 45 mg in 1,14-mL water for injection. Long acting contains 13.5 mg of somatropin, 1.2 mg of zinc acetate, 0.8 mg of zinc carbonate, and 68.9 mg of poly-L-glutamate. In another formulation, each vial contains 8.8 mg of somatropin (approximately 26.4 IU), 60.2 mg of sucrose and 2.05 mg of O-phosphoric acid. The pH is adjusted with sodium hydroxide or O-phosphoric acid. The diluent is BWFI, USP containing 0.9% benzyl alcohol added as an antimicrobial preservative.

Each vial contains 52.5 mg of Tenecteplase, 0.55 g of l-arginine, 0.17 g of phosphoric acid, and 4.3 mg of polysorbate 20, which includes a 5% overfill.

Each vial contains 1.1 mg thyrotropin alpha (>4 IU), 36 mg of mannitol, 5.1 mg of sodium phosphate, and 2.4 mg of sodium chloride. After reconstitute with 1.2 mL of SWFI, USP, the thyrotropin alpha concentration is 0.9 mg/mL. The pH of the reconstituted solution is approximately 7.0.

It is supplied at a nominal concentration of 14 mg/mL Tositumomab in 35 mg and 225 mg single-use vials. The formulation contains 10% (w/v) maltose (145 mM). The formulation for the dosimetric and the therapeutic dosage forms contains 5.0-6.0% (w/v) of povidone, 1 -2 mg/mL of maltose (dosimetric dose) or 9-15 mg/mL of maltose (therapeutic dose), 0.85-0.95 mg/mL of sodium chloride, and 0.9-1.3 mg/mL of ascorbic acid. The pH is approximately 7.0.

Each vial contains 440 mg of Trastuzumab, 9.9 mg of l-histidine HCI, 6.4 mg of l-histidine, 400 mg of (alpha)-trehalose dihydrate, and 1.8 mg of polysorbate 20, USP. Reconstitution with only 20 mL of the supplied BWFI, USP, containing 1.1% of benzyl alcohol as a preservative yields a multidose solution containing 21 mg/mL of Trastuzumab, at a pH of approximately 6.

Abbreviations. AHF, antihemophilic factor; BWFI, bacteriostatic water for injection; DP, drug product; EDTA, ethylenediaminetetraaceticacid; FSH, follicle-stimulating hormone; G-CSF, granulocyte colony-stimulating factor; hBNP, human B-type natriuretic peptide; lgG1, immunoglobulin G1; IU, International Unit; MAb, monoclonal antibody; MW, molecular weight; rDNA, recombinant DNA; rhDNase, recombinant human deoxyribonuclease I; rhu GM-CSF, recombinant human granulocyte-macrophage colony-stimulating factor; SWFI, sterile water for injection; TNFR, tumor necrosis factor receptor; tPA, tissue plasminogen activator.

Albumin, human Aluminum hydroxide

Amorphous aluminum hydroxyphosphate

Benzyl alcohol

Cresol

Ethylenediamineteraacetic acid

Glutathione

Glycerol

Glycine

Imidazole

L-histidine

Maltose

Mannitol

Parabens

Polysorbate 80

Sodiumdodecyl sulphate

Sucrose

Trehalose dehydrate Tri-N-butyl phosphate Tromethamine Zinc

0 0

Post a comment