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Semaglutide (Ozempic)

Trade Name : Ozempic

Novo Nordisk

INJECTION, SOLUTION

Strength 1.34 mg/mL

SEMAGLUTIDE GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Semaglutide (Ozempic) which is also known as Ozempic and Manufactured by Novo Nordisk. It is available in strength of 1.34 mg/mL per ml. Read more

Semaglutide (Ozempic) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: RISK OF THYROID C-CELL TUMORS
  • See full prescribing information for complete boxed warning.
  • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined (, ).
  • OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (, ).
  • Warnings and Precautions, Macrovascular Outcomes (5.8) Removed 01/2020
  • u00a0
  • 1
  • OZEMPIC is indicated:
  • Limitations of Use
  • OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as:
  • Limitations of Use:
  • No data
  • Injection: 2 mg/1.5 mL (1.34 mg/mL) of semaglutide as a clear, colorless solution available in:
  • Injection: 2 mg/1.5 mL (1.34 mg/mL) available in:
  • OZEMPIC is contraindicated in patients with:
  • No data
  • Pancreatitis:
  • Diabetic Retinopathy Complications:
  • Never share an OZEMPIC pen between patients
  • Hypoglycemia:
  • Acute Kidney Injury:
  • Hypersensitivity Reactions:
  • The following serious adverse reactions are described below or elsewhere in the prescribing information:
  • u2022 Risk of Thyroid C-cell Tumors n
  • u2022 Pancreatitis n
  • u2022 Diabetic Retinopathy Complications n
  • u2022 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulinn
  • u2022 Acute Kidney Injury n
  • u2022 Hypersensitivity n
  • The most common adverse reactions, reported in u22655% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation ().
  • Oral Medications
  • 7.2
  • Females and Males of Reproductive Potential
  • 8.3
  • In the event of overdose, appropriate supportive treatment should be initiated according to the patientu2019s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of OZEMPICof approximately 1 week.
  • OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is CHNO and the molecular weight is 4113.58 g/mol.
  • Structural formula:
  • OZEMPIC is a sterile, aqueous, clear, colorless solution. Each pre-filled pen contains a 1.5 mL solution of OZEMPIC equivalent to 2 mg semaglutide. Each 1 mL of OZEMPIC solution contains 1.34 mg of semaglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14.0 mg; phenol, 5.50 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • No data
  • In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [5-, 17-, and 59-fold the maximum recommended human dose (MRHD) of 1 mg/week, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (2-, 5-, and 17-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (2X human exposure).
  • Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies .
  • Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).
  • In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.1-, 0.4-, and 1.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in oestrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at u22650.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight.
  • No data
  • How Supplied
  • OZEMPIC injection is supplied as a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector in the following packaging configurations:
  • Each OZEMPIC pen is for use by a single patient. An OZEMPIC pen must never be shared between patients, even if the needle is changed .
  • Recommended Storage
  • Prior to first use, OZEMPIC should be stored in a refrigerator between 36u00baF to 46u00baF (2u00baC to 8u00baC) (Table 9). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen.
  • After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature (59u00b0F to 86u00b0F; 15u00b0C to 30u00b0C) or in a refrigerator (36u00b0F to 46u00b0F; 2u00b0C to 8u00b0C). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.
  • Always remove and safely discard the needle after each injection and store the OZEMPIC pen without an injection needle attached. Always use a new needle for each injection.
  • The storage conditions are summarized in Table 9:
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • Risk of Thyroid C-cell Tumors
  • Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician .
  • Pancreatitis
  • Inform patients of the potential risk for pancreatitis. Instruct patients to discontinue OZEMPIC promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting) n
  • Diabetic Retinopathy Complications
  • Inform patients to contact their physician if changes in vision are experienced during treatment with OZEMPIC n
  • Never Share an OZEMPIC Pen Between Patients
  • Advise patients that they must never share an OZEMPIC pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens .
  • Dehydration and Renal Failure
  • Advise patients treated with OZEMPIC of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs .
  • Hypersensitivity Reactions
  • Inform patients to stop taking OZEMPIC and seek medical advice promptly if symptoms of hypersensitivity reactions occur.
  • Pregnancy
  • Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant n n
  • Inform patients if a dose is missed, it should be administered as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day. In each case, inform patients to resume their regular once weekly dosing schedule .
  • Manufactured by:Novo Nordisk A/S
  • DK-2880 Bagsvaerd
  • Denmark
  • For information about OZEMPIC contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536
  • 1-888-693-6742
  • Date of Issue: January 2020
  • Version: 4
  • OZEMPICn- and NovoFinen- are registered trademarks of Novo Nordisk A/S.
  • PATENT INFORMATION
  • u00a9 2020 Novo Nordisk
  • OZEMPIC (oh-ZEM-pick)
  • (semaglutide)
  • injection, for subcutaneous use
  • Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • Read this Medication Guide before you start using OZEMPIC and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What is the most important information I should know about OZEMPIC?
  • OZEMPIC may cause serious side effects, including:
  • What is OZEMPIC?
  • OZEMPIC is an injectable prescription medicine used:
  • It is not known if OZEMPIC can be used in people who have had pancreatitis.
  • OZEMPIC is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
  • It is not known if OZEMPIC is safe and effective for use in children under 18 years of age.
  • Do not use OZEMPIC if:
  • Before using OZEMPIC, tell your healthcare provider if you have any other medical conditions, including if you:
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I use OZEMPIC?
  • Your dose of OZEMPIC and other diabetes medicines may need to change because of:
  • What are the possible side effects of OZEMPIC?
  • OZEMPIC may cause serious side effects, including:
  • The most common side effects of OZEMPIC may include
  • Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of OZEMPIC.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1u2011800u2011FDAu20111088.n
  • General information about the safe and effective use of OZEMPIC.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OZEMPIC for a condition for which it was not prescribed. Do not give OZEMPIC to other people, even if they have the same symptoms that you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about OZEMPIC that is written for health professionals.
  • For more information, go to OZEMPIC.com or call 1-888-693-6742.
  • What are the ingredients in OZEMPIC?
  • Active Ingredient:
  • Inactive Ingredients:
  • Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark
  • OZEMPIC is a registered trademark of Novo Nordisk A/S.
  • PATENT Information: http://novonordisk-us.com/products/product-patents.html
  • u00a9 2020 Novo Nordisk
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised: 01/2020
  • No data
  • No data
  • 1 mg
  • NDC 0169-4136-n
  • List 413602
  • OZEMPICn
  • (semaglutide) injection
  • For Single Patient Use Only
  • 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen
  • Each pen delivers doses of 1 mg only
  • For subcutaneous use only
  • Rx only
  • Once weekly
  • Discard pen 8 weeks after first use.
  • REFRIGERATE u2013 DO NOT FREEZE.
  • Recommended for use with NovoFine or NovoFine Plus disposable needles.
  • Contains: 2 Ozempic pens, 4 NovoFine Plus 32G needles, Product Literature.
  • Dispense the enclosed Medication Guide to each patient.
  • 0.25 mg
  • 0.5mg
  • NDC 0169-4132-n
  • List 413212
  • OZEMPICn
  • (semaglutide) injection
  • For Single Patient Use Only
  • 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen
  • Pen delivers doses of 0.25 mg, 0.5 mg
  • For subcutaneous use only
  • Rx only. Once weekly
  • Discard pen 8 weeks after first use.
  • REFRIGERATE u2013 DO NOT FREEZE.
  • Recommended for use with NovoFine orNovoFine Plus disposable needles.
  • Contains: 1 Ozempic pen, 6 NovoFine Plus 32G needles, Product Literature.
  • Dispense the enclosed Medication Guide to each patient.

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