*Benefits include proven risk reduction in CV and kidney events. CV events = SUSTAIN 6: Results apply to Ozempic^® 0.5 mg and 1 mg plus SOC vs placebo plus SOC in adults with T2D who have high CV risk, or established ASCVD.² Kidney events = FLOW: Composite primary endpoint was eGFR decline (≥50%), kidney failure, or death due to kidney-related or CV causes in adults with T2D and CKD. Ozempic^® demonstrated a 24% RRR vs placebo (4.5% ARR) when both were added to SOC. SUSTAIN 7: Mean change in at Week 40 (+ MET), baseline 8.2% (N=1201): -1.5 %Ozempic^® 0.5 mg (n=301) vs -1.1% dulaglutide 0.75 mg (n=299), (P<0.0001); -1.8% Ozempic^® 1 mg (n=300) vs -1.4% dulaglutide 1.5 mg (n=299),(P<0.0001).¹

†Patients with T2D, T2D + CVD and T2D + CKD.^1-5

‡In head-to-head studies vs placebo, sitagliptin 100 mg, exenatide ER 2 mg, study-titrated insulin glargine, dulaglutide 1.5 mg, canagliflozin 300 mg, and liraglutide 1.2 mg.^4-12

§Ozempic^® is indicated for the treatment of adults with insufficiently controlled T2D as an adjunct to diet and exercise.¹

| |HbA_1c and weight reduction from the start.

ARR=absolute risk reduction; ASCVD=atherosclerotic cardiovascular disease; CKD=chronic kidney disease; CV=cardiovascular;
CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; ER=extended-release; GLP-1 RA=glucagon-like peptide-1 receptor agonist; MACE=major adverse cardiac event; RRR=relative risk reduction; SOC=standard of care; T2D=type 2 diabetes.

Ozempic® 0.25mg solution for injection in prefilled pen, 1.5ml,1 pen and 4 disposable needles

Ozempic® 0.5mg solution for injection in prefilled pen, 1.5ml,1 pen and 4 disposable needles

Ozempic® 1mg solution for injection in prefilled pen, 3ml, 1 pen and 4 disposable needles

Qualitative and quantitative composition 1 ml of solution contains 1.34 mg of semaglutide. Therapeutic indications Ozempic® is indicated for the treatment of

adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise; as monotherapy when metformin is considered inappropriate due to intolerance or contraindications or in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see Special warnings and precautions for use, Interaction with other medicinal products and other forms of interaction and Pharmacodynamic properties. Posology and method of administration Posology The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 1 mg are not recommended. When Ozempic® is added to existing metformin and/or thiazolidinedione therapy or to a sodium glucose cotransporter 2 (SGLT2) inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged. When Ozempic® is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia. Self-monitoring of blood glucose is not needed in order to adjust the dose of Ozempic®. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic® is started and insulin is reduced. A stepwise approach to insulin reduction is recommended. Missed dose If a dose is missed, it should be administered as soon as possible and 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, patients can then resume their regular once weekly dosing schedule. Changing the dosing day The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued. Special populations Elderly No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited. Renal impairment No dose adjustment is required for patients with mild, moderate or severe renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited. Semaglutide is not recommended for use in patients with end-stage renal disease. Hepatic impairment No dose adjustment is required for patients with hepatic impairment. experience with the use of semaglutide in patients with severe hepatic impairment is limited. Caution should be exercised when treating these patients with semaglutide. Paediatric population the safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established. No data are available. Method of administration Ozempic® is to be administered once weekly at any time of the day, with or without meals. Ozempic® is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed without dose adjustment. Ozempic® should not be administered intravenously or intramuscularly. Contraindications Hypersensitivity to the active substance or to any of the excipients.Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Semaglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapid discontinuation or dose reduction of insulin when treatment with a GLP-1 receptor agonist is started. There is no experience in patients with congestive heart failure NYHA class IV and semaglutide is therefore not recommended in these patients. Gastrointestinal effects Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients, with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Hypoglycaemia Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide. Diabetic retinopathy in patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. These patients should be monitored closely and treated according to clinical guidelines. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded. Sodium content This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.Interaction with other medicinal products and other forms of interaction Semaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Semaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption. Paracetamol Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a standardised meal test. No dose adjustment of paracetamol is necessary when administered with semaglutide. Oral contraceptives Semaglutide is not anticipated to decrease the effect of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree when an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide. Exposure of ethinylestradiol was not affected; an increase of 20% was observed for levonorgestrel exposure at steady state. Cmax was not affected for any of the compounds. Atorvastatin Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg). Atorvastatin Cmax was decreased by 38%. This was assessed not to be clinically relevant. Digoxin Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg). Metformin Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days. Warfarin and other coumarin derivatives Semaglutide did not change the overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner. However, cases of decreased INR have been reported during concomitant use of acenocoumarol and semaglutide. Upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.Fertility, pregnancy and lactation Women of childbearing potential are recommended to use contraception when treated with semaglutide. Pregnancy studies in animals have shown reproductive toxicity. There are limited data from the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life. Breast-feeding in lactating rats, semaglutide was excreted in milk. As a risk to a breast-fed child cannot be excluded, semaglutide should not be used during breast-feeding. Fertility The effect of semaglutide on fertility in humans is unknown. Semaglutide did not affect male fertility in rats. In female rats, an increase in oestrous length and a small reduction in number of ovulations were observed at doses associated with maternal body weight loss. Effects on ability to drive and use machines Semaglutide has no or negligible influence on the ability to drive or use machines. When it is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Undesirable effects: Very Common (≥1/10): Hypoglycaemia when used with insulin or sulfonylurea, nausea and diarrhoea. Common (≥1/100 to <1/10): Hypoglycaemia when used with other OADs, decreased appetite, dizziness, Diabetic retinopathy complications, Vomiting, Abdominal pain, Abdominal distension, Constipation, Dyspepsia, Gastritis, Gastro-oesophageal reflux disease, Eructation, Flatulence, Cholelithiasis, Fatigue, Increased lipase, Increased amylase, Weight decreased. Uncommon (≥1/1,000 to <1/100): Hypersensitivity, Dysgeusia, Increased heart rate, Delayed gastric emptying, acute pancreatitis, Injection site reactions. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction; very rare (<1/10,000) and not known: Angioedema, intestinal obstruction. Overdose Overdoses of up to 4 mg in a single dose, and up to 4 mg in a week have been reported in clinical trials. The most commonly reported adverse reaction was nausea. All patients recovered without complications. There is no specific antidote for overdose with semaglutide. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s 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 semaglutide of approximately 1 week.List of excipients Disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.Incompatibilities In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products. Shelf life Before first use 3 years. After first opening In-use shelf life: 6 weeks. Store below 30 °C or in a refrigerator (2 °C–8 °C). Do not freeze Ozempic. Keep the pen cap on when the pen is not in use in order to protect it from light.Special precautions for storage Store in a refrigerator (2 °C–8 °C). Keep away from the cooling element. Do not freeze Ozempic. Keep the pen cap on in order to protect from light..Special precautions for disposal and other handling the patient should be advised to discard the injection needle after each injection and store the pen without an injection needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing. The pen is for use by one person only. Ozempic® should not be used if it does not appear clear and colourless or almost colourless. Ozempic® should not be used if it has been frozen. Ozempic® can be administered with 30G, 31G, and 32G disposable needles up to a length of 8 mm. Any unused medicinal product and other waste material should be disposed of in accordance with local requirements. For further information please refer to the full Summary of Product Characteristics.
Market Authorization Holder: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark. Based on Summary of Product Characteristics and PIL dated Mar 24 JO24OZM00006

LB25OZM00030 - June 2025

Novo Nordisk Pharma sarl
Azar Bldg- Horsh Tabet
Dimitri El Hayek St
Beirut- Lebanon
Tel: +961 1 488664
www.novonordisk.com.lb