Expiration date: 03/2026

Method of administration and dosage

Always use the drug in full accordance with the recommendations of your doctor. If in doubt, consult your doctor.

The dose and mode of administration of the drug will be selected by your attending physician, taking into account your individual characteristics.

Recommended dose

Adults

The recommended starting dose is 0.5 mg once a week.

The recommended therapeutic dose is 2.4 mg once a week.

Your treatment will start with an initial dose, which will gradually increase over the course of 16 weeks of treatment as follows:

• Your doctor will instruct you to gradually increase the dose every 4 weeks, as shown in the table below, until you reach the recommended therapeutic dose of 2.4 mg once a week.
• Once you reach the recommended dose of 2.4 mg, do not increase this dose again.

Dose increase Weekly dose

Week 1-4 0.25 mg

Week 5-8 0.5 mg

Week 9-12 1 mg

Week 13-16 1.7 mg

The maintenance dose is 2.4 mg

Weekly doses exceeding 2.4 mg are not recommended.

Your doctor will regularly evaluate your treatment.

Use in children and adolescents

Efficacy and safety for children have not been established.

Route and method of administration

The drug Semavic® Next is injected under the skin (subcutaneous injection) using a pen. Never administer Semavic®. Next to a vein or a muscle.

• The best injection sites are the forearms, abdomen, or upper thighs.
• Before using a pen for the first time, ask your doctor how to handle it. Carefully read the instructions for using the Semavic® pre-filled multi-dose disposable pen. Next, enclosed in the package. Use the pen only in accordance with the instructions for use.
• Always make sure that you are using the correct dosage of Semavic®. Next.

Administer the drug Semavic® Next, once a week and, if possible, on the same day every week. If necessary, you can change the day of your weekly injection of this drug if at least 3 days have passed since your last injection. After choosing a new intake day, continue taking the drug once a week.

You can inject yourself at any time of the day, regardless of your meal.

Patients with type 2 diabetes mellitus

Tell your doctor if you have T2DM. Your doctor may adjust the dose of medications used to treat type 2 diabetes to prevent a decrease in blood sugar.

• Do not combine Semavic® Next to other medications that you administer subcutaneously (for example, insulins).
• Do not use Semavic® Next in combination with other drugs containing GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

Duration of therapy

Your doctor will regularly evaluate your condition and tell you how long you should use Semavic®. Next.

If you forgot to apply Semavic® Next

If you forgot to administer the dose and:

• It has been 5 days or less since you were supposed to inject Semavic® Next, enter the missed dose as soon as you remember. Then enter the next dose, as usual, on the appointed day.
• It has been more than 5 days since you were supposed to inject Semavic® Next - do not administer the missed dose. Wait and administer the next dose as usual on the scheduled day.

Never give a double dose to make up for a missed dose.

If you have stopped using Semavic® Next

Do not stop using Semavic®. Next without consulting your doctor. If you have any additional questions about the use of Semavic® Please contact your doctor.

Indications

Semavic Next is indicated for use in adults over the age of 18 years in addition to a low-calorie diet and physical activity to control body weight, including weight loss and maintenance, in adults with an initial body mass index (BMI) equal to:

• ≥ 30 kg/m2 (obese), or
• ≥ 27 kg/m2, but <30 kg/m2 (increased body weight) in the presence of at least one concomitant pathology related to body weight, such as dysglycemia (prediabetes or type 2 diabetes mellitus (T2DM)), hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular diseases.

Composition

The active ingredient is semaglutide.

Each ml of the solution contains 2.27 mg of semaglutide.

Each pre-filled pen contains 6.8 mg of semaglutide in 3 ml of solution (4 doses of 1.7 mg each).

Other ingredients are: disodium hydrophosphate dihydrate, propylene glycol, phenol, hydrochloric acid solution of 10% or sodium hydroxide solution of 10% (for pH correction), water for injection.

The drug Semavic® Next contains sodium (see section 2)

Contraindications

Do not use Semavic® Next if you have:

• hypersensitivity to semaglutide or any of the excipients included in the preparation and listed in section 6;
• a history of medullary thyroid cancer, including family history;
• multiple endocrine neoplasia (MEN) type 2;
• type 1 diabetes mellitus (DM1); diabetic ketoacidosis;
• severe liver failure;
• end-stage renal failure (creatinine clearance <15 ml/min);
• chronic heart failure (CHF) of the IV function

Special instructions

Before using Semavic® Please consult your doctor.

Be sure to notify your attending physician if any of the following points apply to you:

• If you have gastrointestinal disorders

During treatment with Semavic® Next, you may experience adverse reactions from the gastrointestinal tract, such as nausea, vomiting, or diarrhea, which can cause dehydration (loss of fluid), which in rare cases can lead to impaired kidney function. It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems.

• If you have previously had pancreatitis (inflammation of the pancreas)
• If you have severe and persistent abdominal pain, heartburn, nausea or vomiting, or a worsening of your general condition, consult a doctor immediately, as this may be a sign of acute pancreatitis (inflammation of the pancreas).
• If you have signs of cholecystitis (inflammation of the gallbladder) - pain in the right hypochondrium, which may radiate to the shoulder, shoulder blade or collarbone, nausea, belching, jaundice of the sclera or skin, itchy skin.
• If you have type 2 diabetes

Semavic® Next is not a substitute for insulin.

Do not use Semavic® Next in combination with other GLP-1 receptor agonists, as this can lead to increased adverse reactions and overdose.

• If you are taking sulfonylureas or insulin preparations. The combination of these drugs with Semavic® Next may increase the risk of lowering blood sugar levels (hypoglycemia). You may need to reduce the dose of sulfonylureas or insulin, consult your doctor.
• If you have diabetic retinopathy (diabetic eye disease)

Rapid improvement in blood sugar control can lead to a temporary exacerbation of diabetic eye disease. If you experience vision problems, consult your doctor.

The use of Semavic® is not recommended. It is not necessary if you have the following conditions/diseases due to lack of data on efficacy and safety or limited experience of use:

• the use of other drugs to reduce body weight;
• type 1 diabetes mellitus;
• severe liver failure;
• end-stage renal failure;
• chronic heart failure (CHF) of functional class IV (in accordance with the NYHA classification).

If you have T2DM, then when using Semavic® Next, in combination with sulfonylurea derivatives or insulin, blood sugar levels may decrease (hypoglycemia), which may weaken the ability to concentrate. Do not drive or use machinery if you have any signs of hypoglycemia (see section "Special instructions and precautions" for information about the increased risk of lowering blood sugar levels and section 4 for warning signs of low blood sugar. Contact your doctor for more information.

Traceability

To improve the traceability of the drug, it is necessary to record the batch and expiration date of the administered drug.

Auxiliary substances

The drug Semavic® Next contains less than 1 mmol of sodium (23 mg) per dose (2.4 mg), meaning it essentially contains no sodium.

Packaging and release form

A solution for subcutaneous administration, 3 ml each into a cartridge, which is installed in a plastic multidose disposable pen for multiple injections, allowing doses of 1.7mg /dose (4 doses). 1 pre-filled multi-dose disposable pen for multiple injections and 1 pack of cardboard containing 4 disposable needles with a leaflet containing instructions for using the pen are placed in a pack of cardboard.

Side effects

Like all medications, Semavic® Next may cause undesirable reactions, but they do not occur in everyone.

The most serious adverse reactions

Stop using Semavic®. Seek immediate medical attention in case of one of the following signs of a severe allergic reaction (anaphylactic reactions, angioedema), which has been observed rarely (may occur in no more than 1 person out of 1000):

• difficulty breathing or swallowing;
• dizziness;
• swelling of the face, lips, tongue or throat;
• severe itching of the skin, the appearance of rashes or blisters;
• fainting (drop in blood pressure) with rapid heartbeat and increased sweating.
• pallor and coldness of the skin, dizziness or weakness.

If you have type 2 diabetes, tell your doctor if during treatment with Semavic® If you have problems with your eyesight, for example, a visual impairment that has been observed frequently (may occur in no more than 1 person out of 10):

• Complications of diabetic eye disease (diabetic retinopathy).

Seek medical help immediately if you experience symptoms of pancreatic inflammation (acute pancreatitis), which has been observed infrequently (occur in no more than 1 in 100):

• severe and prolonged abdominal pain, which can radiate to the back;
• sudden intense pain throughout the abdominal cavity;
• heartburn;
• vomiting attacks;
• bloating and flatulence;
• deterioration of the general condition: increased body temperature, decreased blood pressure, tachycardia, sweating, pallor or jaundice of the skin.

Other possible adverse reactions that may occur when using Semavic® Next

Very common (occurs in more than 1 out of 10 people):

• Headache;
• Nausea;
• Vomiting;
• Diarrhea;
• Constipation;
• Abdominal pain;
• Feeling weak or tired.

Common (occurs in no more than 1 person out of 10):

• Dizziness;
• Dysgeusia
• Upset stomach or indigestion;
• Burping;
• Flatulence;
• Bloating;
• Inflammation of the stomach ("gastritis") - symptoms include abdominal pain, nausea, or vomiting;
• Reflux or heartburn, also called "gastroesophageal reflux disease";
• Cholelithiasis;
• Hair loss;
• Reactions at the injection site;
• Reduction of blood sugar (hypoglycemia) in patients with diabetes mellitus*.

*Signs of a decrease in blood sugar may appear suddenly. These may include: cold sweat, cool pale skin, headache, rapid heartbeat, feeling unwell (nausea) or very hungry, changes in vision, drowsiness or weakness, nervousness, anxiety or confusion, difficulty concentrating, or trembling. Your doctor will tell you how to increase your blood sugar and what to do if you notice these warning signs. Hypoglycemia is more likely if you are also taking medications derived from sulfonylureas or insulin. Your doctor may reduce the dose of these medications before you start using Semavic®. Next.

Infrequently (occur in no more than 1 in 100):

• Increased heart rate;
• Low blood pressure (hypotension);
• Decrease in blood pressure during the transition from a horizontal position (sitting or lying down) to a vertical (standing) (orthostatic hypotension);
• Increased levels of lipase and amylase in the blood test;
• Delayed gastric emptying.

Rare (occurs in no more than 1 person out of 1000):

• Intestinal obstruction
• Cholangitis
• Cholestatic jaundice

Tell your doctor if you experience any new or worsening symptoms.

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the leaflet. You can also report unwanted reactions directly through the notification system of the member States of the Eurasian Economic Union. By reporting adverse reactions, you are helping to gain more information about the safety of the drug.

Pharmacotherapeutic group

hypoglycemic agent - an analogue of glucagon-like peptide-1

Interaction with other medicinal products

Tell your doctor if you are taking, have recently taken, or may start taking any other medications.

Tell your doctor if you are taking medications containing warfarin or other similar medications to reduce blood clotting (oral anticoagulants). You may need to have a frequent blood test to determine your blood's ability to clot.

Influence on the ability to drive a car and other mechanisms

Semavic® Next will not affect your ability to drive vehicles and use machinery. However, some patients may experience dizziness when using Semavic®. Next during the first 4 months of treatment (see the section "Possible adverse reactions"). If you feel dizzy, you should not drive or operate machinery until you feel better. If you need any additional information, please contact your doctor.

Use during pregnancy and lactation

Do not use Semavic® It is not necessary during pregnancy, as it is not known whether the drug can affect your unborn child.

Use reliable contraceptives during the use of Semavic®. Next.

If you want to become pregnant, you should stop taking Semavic®. Next, at least two months before the planned pregnancy.

If you become pregnant or think you may become pregnant, or plan to have a baby while using Semavic® Next, consult your doctor immediately, as your treatment with Semavic® The next thing will need to stop.

Do not use Semavic® It is not necessary if you are breastfeeding, because it is not known whether the drug penetrates into human breast milk.

Pharmacodynamics

What is Semavic®? Next and what is it used for

Semavic® Next is a drug for weight loss and maintenance of body weight, which contains the active ingredient semaglutide. Semaglutide is an analog of human glucagon-like peptide 1 (GLP-1), which is excreted from the intestine after eating. Semavic® Next affects the receptors in the brain that control your appetite, making you feel full and less hungry, as well as experiencing less cravings for food. This will help you eat less food and reduce body weight. Semavic® Next is indicated as an addition to a low-calorie diet and exercise.

SemavicNext is indicated for use in adults over 18 years of age with established cardiovascular disease and obesity or overweight to reduce the risk of major cardiovascular events.*

*Major cardiovascular events include: death due to cardiovascular disease, non-fatal myocardial infarction, and non-fatal stroke.

If there is no improvement or you feel it, you should consult a doctor.

Storage temperature

from 2℃ to 8℃

The dosage form

is a colorless or almost colorless transparent solution.

Overdose

If you have used Semavic® Next in a higher dose than required

Contact your doctor immediately. You may experience adverse reactions from the gastrointestinal tract, such as nausea, vomiting, or diarrhea. This can lead to dehydration, which in rare cases can lead to impaired kidney function.

Special storage conditions

Store Semavic® Next in the refrigerator at a temperature of 2 to 8 °C.

Do not freeze, do not place near the freezer, do not use if the product has been frozen.

After the first use

Store a used or portable pen with the drug at a temperature of no more than 30 °C or at a temperature from 2 °C to 8 °C (in the refrigerator) for no more than 6 weeks.

Do not freeze.

After use, cover the pen with a cap to protect it from light.

Keep away from excessive heat.