tapering off [0.001):<0.001 Sixty-seven (58%) of the 115 randomized patients were male. The adjusted mean treatment difference on the increase in lean body mass from baseline was significantly greater in males (2.9 kg) than females (0.8 kg). Ninety-seven (84%) of the 115 randomized patients had adult onset GHD. The adjusted mean treatment differences on the increase in lean body mass from baseline were not significantly different in AO GHD (2.1 kg) compared with childhood onset GHD (1.0 kg) patients. However, there were relatively few patients with childhood onset GHD (n=18) on which to base the comparison. Analysis of the treatment difference on the change from baseline in total fat mass (by DXA) revealed a significant decrease (p> <0.001) in the Saizen-treated group compared to the placebo group. Saizen also produced beneficial effects on several bone turnover markers including bone specific alkaline phosphatase, C-terminal propeptide, osteocalcin, urine deoxypyridinoline and iPTH. One hundred and eleven patients were enrolled in an open label follow up study and treated with Saizen for an additional 6-30 months. During this period, the beneficial effects on lean body mass and total fat mass achieved during the initial six months of treatment were maintained. How Supplied/Storage and Handling How Supplied Saizen can be administered using (1) a standard sterile disposable syringe and needle, (2) a compatible Saizen needle-free injection device or (3) a compatible Saizen needle injection device. For proper use, refer to the Instructions for Use provided with the administration device. Saizen is a sterile, non pyrogenic, white, lyophilized powder supplied in packages containing: 1 vial of 5 mg Saizen and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2 1 vial of 8.8 mg Saizen and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1 1 click.easy cartridge of 8.8 mg Saizen and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol as a antimicrobial preservative NDC 44087-1080-1 1 Saizenprep cartridge of 8.8 mg Saizen and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol as antimicrobial preservative NDC 44087-0016-1 Storage and Handling Before Reconstitution - Saizen should be stored at room temperature (15 -30 C/59 -86 F). Expiration dates are stated on the labels. After Reconstitution - Saizen 5 mg and 8.8 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (2 8 C/36 46 F) for up to 14 days. Saizen 8.8 mg click.easy cartridge reconstituted with the Sterile Water for Injection, 0.3% (w/v) metacresol provided should be stored under refrigeration (2 8 C/36 46 F) for up to 21 days. Saizen 8.8 mg Saizenprep cartridge reconstituted with the Sterile Water for Injection, 0.3% (w/v) metacresol provided should be stored under refrigeration (2 -8 C/36 -46 F) for up to 21 days. Avoid freezing reconstituted vials or cartridges of Saizen. Patient Counseling Information Prior to self-administration of the product at home, ensure to train patients and caregivers how to prepare and administer the product correctly to help avoid wrong technique and dosing errors. Patients being treated with Saizen (and/or their parents) should be informed about the potential benefits and risks associated with Saizen treatment. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects. Patients and caregivers who will administer Saizen should receive appropriate training and instruction on the proper use of Saizen from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication. To reconstitute Saizen, inject the diluent into the vial of Saizen aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Saizen MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless. Never Share a Saizen Needle Between Patients Counsel patients that they should never share a Saizen needle with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection. For drug preparation instructions for Saizen click.easy cartridges, please refer to the Instructions for Use provided with click.easy reconstitution device. For drug preparation instructions for Saizenprep cartridges, please refer to the Instructions for Use provided with Saizenprep reconstitution device. Manufactured for: EMD Serono, Inc., Rockland, MA 02370 USA click.easy Reconstitution Device Saizen (somatropin) for injection, for subcutaneous use 8.8 mg INSTRUCTIONS FOR USE For complete dosing and safety information, please refer to the Saizen Package Insert. COMPOSITION Each vial of Saizen 8.8 mg contained in the 5.83 mg/mL click.easy device contains the following ingredients: Active substance: Somatropin (Recombinant Human Growth Hormone) 8.8 mg. Excipients: Sucrose, Phosphoric acid, Sodium Hydroxide; 1 mL of the reconstituted Saizen solution contains 5.83 mg of somatropin when reconstituted with the contents of the diluent cartridge. COMPOSITION OF DILUENT Each cartridge of diluent contained in the click.easy reconstitution device contains the following ingredients: 5.83 mg/mL click.easy Active substance: Metacresol USP (4.52 mg), Excipients: Phosphoric acid 85% to adjust pH, Water for Injection, USP (1.51 mL) Patients with a known sensitivity to any of the above active substances or excipients should avoid using this product. PHARMACEUTICAL FORM Powder and diluent for solution for injection: Powder and diluent (0.3% (w/v) metacresol in water for injection) for parenteral use. METHOD AND ROUTE OF ADMINISTRATION The product (powder in vials) must be reconstituted with the enclosed diluent (0.3% (w/v) metacresol in water for injection) using the click.easy reconstitution device. The reconstituted solution is intended for subcutaneous administration (under the skin) and should be clear with no particles. If the solution contains particles, it must not be injected. IMPORTANT INFORMATION Patients should be thoroughly instructed in the reconstitution procedure. For young children, the reconstitution process should be supervised by an adult. For administration of Saizen 8.8 mg contained in the click.easy device, please read the following instructions carefully. Please consult your doctor, nurse or pharmacist if you have any questions concerning the reconstitution process. Check that the click.easy reconstitution device contains an unused Saizen vial (a) and an unused diluent cartridge (c). Do NOT use the device if the vial or cartridge appear empty or used and return it to your pharmacist or doctor. Wash your hands with soap and water. HOW TO PREPARE YOUR SOLUTION OF Saizen Place the click.easy device vertically on a clean flat surface with the Saizen vial on the bottom and the diluent cartridge outer housing cap (g) on top facing upward. Push on the top diluent cartridge outer housing cap (g) firmly until the Saizen vial outer housing (h) is completely inside the main body. This step breaks the tamper evident seal on the vial. Turn the diluent cartridge outer housing cap (g) clockwise until the green square (f) is visible at the lower end of the narrow rectangular opening. Push the diluent cartridge outer housing cap down very slowly until it will go no further and the green colored square appears at the upper end of the narrow rectangular opening. Check that all the diluent has been transferred into the vial. Dissolve the Saizen powder with the diluent by gently swirling the click.easy device (Note: Do not transfer the diluent forcefully or shake the click.easy device. A fast transfer of the diluent or shaking of the click.easy device will create more foam). Let the solution stand for 2-5 minutes until the Saizen powder is completely dissolved. Turn the click.easy device upside down so the Saizen vial is now on top and pull the diluent cartridge outer housing cap slowly downwards until the solution is completely drawn back into the cartridge. Check that no more than one or two drops of solution remain in the vial. If there are more than one or two drops of solution remaining in the vial, slowly push the diluent cartridge outer housing cap up until some of the solution is back in the vial and gently tap the click.easy device. Then draw the solution slowly again back into the cartridge. Remove any excess air that has been drawn into the cartridge by slowly pushing the cap up until no air bubble is visible in the cartridge. There should be no air bubble in the cartridge (Note: Avoid pulling the cap down too fast, as this will draw air into the cartridge). Turn the click.easy device so that the cap is again on the top. Unscrew the cap and remove it. Remove the cartridge containing the reconstituted Saizen solution from the click.easy device by grasping the end of the cartridge and pulling straight out of the outer housing. Carefully peel off the outer white label on the cartridge using the tab provided by slowly pulling in the direction of the black arrow. Write the reconstitution date on the transparent inner label on the cartridge. This cartridge now contains the reconstituted Saizen solution that will be used for your treatment. The cartridge containing the reconstituted Saizen solution is now ready to be used (Note: Please read the instruction manual provided with the injection device for instruction on how to inject the reconstituted Saizen solution from the cartridge). The Saizen reconstituted solution should be stored in a refrigerator (2 -8 C / 36 -46 F) and should be used within 21 days after reconstitution. Do not freeze. Discard the click.easy device containing the empty Saizen vial safely in accordance with your local requirements. It is not necessary to remove the empty Saizen vial from the click.easy device prior to disposal. Injections should be given in different parts of your body. Do not use any areas in which you feel lumps, firm knots, depressions, or pain; talk to your doctor or healthcare professional about anything you find. Clean the skin at the injection site with soap and water. STABILITY AND STORAGE Vials of Saizen 8.8 mg pre-assembled in the click.easy reconstitution device should be stored in the original package at room temperature (15 -30 C / 59 -86 F). Saizen 8.8 mg reconstituted solution should be stored in a refrigerator (2 -8 C / 36 -46 F) and should be used within 21 days after reconstitution. Do not freeze. HOW SUPPLIED Saizen 8.8 mg contained in the click.easy device is available in the following pack sizes: 1 vial of Saizen 8.8 mg product and 1 cartridge of 1.51 mL diluent pre-assembled in 1 reconstitution device (click.easy ) comprising 1 device housing and 1 sterile transfer cannula NDC 44087-1080-1 Manufactured for: EMD Serono Inc., Rockland, MA 02370 Instructions for Use Saizenprep For use only with Saizen (somatropin) for injection 8.8 mg Important information You must have received training before using Saizenprep (si-zin-prep). Always follow all directions and training provided by your healthcare provider. For children, use of the Saizenprep device must be supervised by an adult. Contact our patient support services at 1-800-582-7989 for questions related to the device or Saizen (somatropin) for injection. What is in the box? Tray Patient Information Leaflet Saizenprep Instructions for Use You will also need: sharps container, pen and alcohol wipes (not included) Important information What is Saizenprep ? Saizenprep is a single use reconstitution (mixing) device used to mix Saizen. How supplied Saizenprep is supplied in a kit. Saizenprep 8.8 mg contains: 8.8 mg vial and 1.51 mL cartridge. Getting to know Saizenprep Saizenprep Reconstitution Device Diluent Cartridge STEP 1 Check supplies Note: Prepare a clean, hard, flat surface as a working area. 1.1 Box: Confirm product is not expired Open box Carefully remove contents 1.2 Wash Hands: Important Wash Hands Warning: Using the device with unclean hands may lead to contamination and possibly infection. 1.1 1.2 1.3 Saizen Vial: Confirm vial label says Saizen Confirm product is not expired Confirm correct strength (e.g. 8.8 mg) Confirm vial is not cracked and cap is not damaged 1.4 Diluent Cartridge: Confirm cartridge label says Diluent for Saizen Confirm product is not expired Confirm correct volume (e.g. 1.51 mL) Confirm cartridge is not cracked 1.3 Vial 1.4 Cartridge 1.5 Saizenprep Packaging and Sterility Seal: Confirm product is not expired Confirm sterility seal is not damaged or loose Confirm packaging is not cracked or damaged Warning: Do not use if any items are damaged or expired. Call patient support services at 1-800-582-7989 for assistance. 1.5 STEP 2 Prepare Saizenprep Saizen Vial: 2.1 Remove blue protective flip off vial cap from vial and throw away (discard) in the trash. 2.2 Clean gray rubber at top of vial with alcohol wipe. 2.1 2.2 Diluent Cartridge: 2.3 Grasp arrow tab to peel outer label and tear off at perforation before discarding in the trash. 2.4 Clean rubber at top of cartridge with alcohol wipe. 2.3 2.4 Saizenprep Packaging: 2.5 Peel sterility seal from packaging and discard in the trash. Caution: Do not attempt to remove device from packaging. 2.5 STEP 3 Attach Saizenprep to vial 3.1 Place Saizenprep on top of vial and push down firmly on packaging until it snaps in place. You will feel and hear a "click" confirming that it is fully inserted. Caution: Make sure that vial is fully inserted inside vial connector. 3.2 Pull off packaging with 1 hand while holding vial with the other hand. Discard packaging in the trash. 3.1 3.2 STEP 4 Attach cartridge 4.1 Hold the green cartridge holder with one hand. With the other hand unscrew the transfer unit and set aside for future use. Note: To enhance cartridge content visibility, line up clear cartridge label space with cartridge holder open slot. 4.2 Insert cartridge into cartridge holder opening with metal tip facing down. You will feel and hear a "click" confirming that it is fully inserted. 4.1 4.2 4.3 Screw transfer unit back onto cartridge holder. You will feel and hear a "click" confirming that it is attached correctly. Caution: Let the plunger rod rise by itself from the transfer unit during attachment step. 4.3 STEP 5 Mix Saizen and Diluent in vial Caution: To avoid foaming, always perform transfers slowly (minimum 10 sec). 5.1 Hold the device at a slight angle. Slowly push down on plunger rod to transfer all Diluent drop by drop to vial. You will feel some resistance. Release plunger rod after transfer is completed. Plunger rod will rise on its own once released. Warning: You may have to perform this step again if there is still Diluent visible in cartridge. 5.1 5.2 Thoroughly mix Saizen and Diluent in vial by gently swirling device in circular motion. Do not shake! Shaking will cause foaming. Inspect vial: IF THEN Liquid in vial is clear Proceed to Step 6 Liquid in vial is foaming Allow device to rest vertically until foam disappears (3-5 minutes) Powder in vial is not completely dissolved Continue to swirl gently until drug dissolves (less than 2 minutes) Liquid in vial is cloudy or has particles Do not use and call 1-800-582-7989 5.2 STEP 6 Draw mixed Saizen into cartridge Caution: Hold Saizenprep straight up - not at an angle when transferring Saizen. 6.1 Turn Saizenprep so vial is on top. Push up on plunger rod to remove all air from cartridge. You may feel some resistance. 6.2 Slowly pull plunger rod halfway down. You will start noticing mixed Saizen flowing into cartridge. Note: You may not have to pull as plunger rod may travel back on its own. 6.1 6.2 6.3 Push up on plunger rod again to remove any remaining air inside cartridge. 6.4 Slowly pull plunger rod downward until it stops. All liquid should now be in the cartridge. Note: It is ok to leave a small amount of air bubbles in the vial. 6.3 6.4 6.5 Hold the device so the top of the cartridge is at eye level and inspect for air bubbles inside the cartridge. The liquid should be at or above the cartridge shoulder line. If the cartridge contains a large air bubble (see example pg 33) repeat steps 6.3 and 6.4. Note: If a large air bubble (liquid is below cartridge shoulder line) is not removed after 5 attempts call patient support services at 1-800-582-7989 for assistance. 6.5 IF Liquid is at or above cartridge shoulder line IF Liquid is below cartridge shoulder line THEN Proceed to step 7 THEN Repeat steps 6.3 and 6.4 STEP 7 Remove cartridge 7.1 Turn Saizenprep so vial is on bottom. Hold cartridge holder with one hand and unscrew transfer unit from cartridge holder with other hand. Discard transfer unit in the trash. Caution: Make sure to hold the cartridge holder when removing the cartridge. 7.2 Remove cartridge from cartridge holder by pulling it straight up. Note: A small drop of Saizen may be visible inside cartridge holder opening. 7.1 7.2 7.3 Put the used cartridge holder with attached vial in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the cartridge holder with attached vial in your household trash. If you do not have an FDA-cleared sharps container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting lid, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and labeled to warn of hazardous waste inside. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal 7.3 STEP 8 Record date 8.1 Write today's date (mixing date) in white box on cartridge inner label. 8.1 STEP 9 Saizen storage and handling 9.1 Store Saizen in the refrigerator between 36 F to 46 F (2 C to 8 C) after mixing. The cartridge will expire in 21 days after mixing (the date written on the cartridge). Saizen vial, Diluent cartridge and mixed Saizen can be stored in the refrigerator near food or other medicine. If you are traveling, keep Saizen away from light and use cool packs to maintain refrigerated temperature between 36 F to 46 F (2 C to 8 C). Warning: Do not freeze Saizen. 9.1 For more information go to www.Saizenus.com or call patient support services at 1-800-582-7989 Manufactured for: EMD Serono, Inc. Rockland, MA 02370 Made in Italy This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: January 2017 EMD Serono, Inc. is a subsidiary of Merck KGaA, Darmstadt, Germany 20067247 MDT-535 US MC-2724-2017 PRINCIPAL DISPLAY PANEL - 5 mg Kit Carton Saizen 5 mg (somatropin) for injection NDC 44087-1005-2 5 mg For subcutaneous injection Rx Only 1 vial Saizen 1 vial Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) EMD Serono PRINCIPAL DISPLAY PANEL - 8.8 mg Kit Carton Saizen 8.8 mg (somatropin) for injection NDC 44087-1088-1 8.8 mg For subcutaneous injection Rx Only 1 vial Saizen 1 vial Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) EMD Serono PRINCIPAL DISPLAY PANEL - 8.8 mg click.easy Kit Carton click.easy Reconstitution Device 5.83 mg/mL Saizen (somatropin) for injection 8.8 mg NDC 44087-1080-1 For subcutaneous injection Approximately 5.83 mg/mL of the drug is delivered Exclusively for use with designated Saizen delivery devices Rx Only 1 vial somatropin 1 cartridge diluent pre-assembled in 1 reconstitution device (click.easy ) including 1 device housing and 1 sterile transfer cannula EMD Serono PRINCIPAL DISPLAY PANEL - 8.8 mg Reconstitution Kit Carton NDC 44087-0016-1 Saizen 8.8 mg (somatropin) for injection 5.83 mg/mL Reconstitution Kit Approximately 5.83 mg/mL of the drug is delivered For subcutaneous injection Exclusively for use with designated Saizen delivery devices Rx only 1 vial Saizen 8.8 mg 1 cartridge of diluent 1 Saizenprep Reconstitution Device EMD SERONO Saizen somatropin kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44087-1005 Packaging # Item Code Package Description 1 NDC:44087-1005-2 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 3 mL Part 2 1 VIAL, GLASS 3.5 mL Part 1 of 2 Saizen somatropin injection, powder, lyophilized, for solution Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (SOMATROPIN) SOMATROPIN 5 mg in 3 mL Inactive Ingredients Ingredient Name Strength SUCROSE 34.2 mg in 3 mL PHOSPHORIC ACID 1.16 mg in 3 mL Packaging # Item Code Package Description 1 3 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Part 2 of 2 BACTERIOSTATIC WATER bacteriostatic water injection Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL Packaging # Item Code Package Description 1 3.5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Saizen somatropin kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44087-1088 Packaging # Item Code Package Description 1 NDC:44087-1088-1 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 3 mL Part 2 1 VIAL, GLASS 3.5 mL Part 1 of 2 Saizen somatropin injection, powder, lyophilized, for solution Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (SOMATROPIN) SOMATROPIN 8.8 mg in 3 mL Inactive Ingredients Ingredient Name Strength SUCROSE 60.2 mg in 3 mL PHOSPHORIC ACID 2.05 mg in 3 mL Packaging # Item Code Package Description 1 3 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Part 2 of 2 BACTERIOSTATIC WATER bacteriostatic water injection Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL Packaging # Item Code Package Description 1 3.5 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 08/29/2000 Saizen CLICKEASY somatropin kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44087-1080 Packaging # Item Code Package Description 1 NDC:44087-1080-1 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 1.51 mL Part 2 1 CARTRIDGE 1.51 mL Part 1 of 2 Saizen CLICKEASY somatropin injection, powder, lyophilized, for solution Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (SOMATROPIN) SOMATROPIN 8.8 mg in 1.51 mL Inactive Ingredients Ingredient Name Strength SUCROSE 60.2 mg in 1.51 mL PHOSPHORIC ACID 2.05 mg in 1.51 mL Packaging # Item Code Package Description 1 1.51 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Part 2 of 2 STERILE WATER sterile water injection Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength WATER METACRESOL Packaging # Item Code Package Description 1 1.51 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 07/09/2004 SaizenPREP somatropin kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44087-0016 Packaging # Item Code Package Description 1 NDC:44087-0016-1 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 1.51 mL Part 2 1 CARTRIDGE 1.51 mL Part 1 of 2 SaizenPREP somatropin injection, powder, lyophilized, for solution Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (SOMATROPIN) SOMATROPIN 8.8 mg in 1.51 mL Inactive Ingredients Ingredient Name Strength SUCROSE 60.2 mg in 1.51 mL PHOSPHORIC ACID 2.05 mg in 1.51 mL Packaging # Item Code Package Description 1 1.51 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Part 2 of 2 STERILE WATER sterile water injection Product Information Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength WATER METACRESOL Packaging # Item Code Package Description 1 1.51 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 10/08/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019764 01/17/2017 Labeler - EMD Serono, Inc. (088514898) Revised: 05/2017 EMD Serono, Inc. Next Interactions Print this page Add to My Med List More about Saizen (somatropin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: growth hormones Consumer resources Saizen Saizen Subcutaneous, Injection (Advanced Reading) Professional resources Other brands: Genotropin , Humatrope , Omnitrope , Norditropin , ... +6 more Related treatment guides Pediatric Growth Hormone Deficiency Adult Human Growth Hormone Deficiency Prader-Willi Syndrome Short Stature for Age> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer EMD Serono, Inc. Drug Class Growth hormones Related Drugs growth hormones somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Serostim Adult Human Growth Hormone Deficiency somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Nutropin , More... Pediatric Growth Hormone Deficiency somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Zomacton , More... Short Stature for Age somatropin , Genotropin , Humatrope , Omnitrope , Norditropin , Zomacton , More... 1 more conditions... Saizen Rating 1 User Review 9.0 /10 1 User Review 9.0 Rate it!} } business enterprise
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