OSAGRAND 3 mg Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Osagrand, 3 mg, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Osagrand and what is it used for
   1. Osagrand has been prescribed to treat postmenopausal osteoporosis
4. Important information before using Osagrand
   1. When not to use Osagrand
   2. Warnings and precautions
   3. Children and adolescents
   4. Osagrand and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to use Osagrand
   1. Continuation of Osagrand treatment
   2. Using a higher dose of Osagrand than recommended
   3. Missing a dose of Osagrand
6. Possible side effects
   1. Immediately inform the nurse or doctor if any of the following severe side effects occur, as immediate medical attention may be necessary:
   2. Other possible side effects
   3. Reporting side effects
7. How to store Osagrand
8. Package contents and other information
   1. What Osagrand, 3 mg, solution for injection in an ampoule contains
   2. What Osagrand, 3 mg, solution for injection in an ampoule looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer:
   5. For more information about the medicine, contact the representative of the marketing authorization holder in Poland:
   6. INFORMATION INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS
   7. MEDICAL
   8. To obtain detailed information, refer to the Summary of Product Characteristics.
   9. Administration of Osagrand, 3 mg, solution for injection in an ampoule:
   10. Missed dose:
   11. Overdose:
   12. General information:

Leaflet attached to the packaging: patient information

Osagrand, 3 mg, solution for injection

Ibandronic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep the leaflet, so you can read it again if needed.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Osagrand and what is it used for
• 2. Important information before using Osagrand
• 3. How to use Osagrand
• 4. Possible side effects
• 5. How to store Osagrand
• 6. Package contents and other information

1. What is Osagrand and what is it used for

Osagrand belongs to a group of medicines called bisphosphonates. It contains the active substance - ibandronic acid.
Osagrand can reverse bone loss by inhibiting bone loss and increasing bone mass in most women who take this medicine, even if they do not notice or feel the difference.
Osagrand may help reduce the risk of bone fractures. A reduction in the number of fractures has been shown in the case of vertebral fractures, but not in the case of hip fractures.
Osagrand, 3 mg, solution for injection in an ampoule is a solution intended for intravenous injection by a doctor or nurse. Do not administer Osagrand injections yourself.

Osagrand has been prescribed to treat postmenopausal osteoporosis

due to an increased risk of fractures.Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones, which often occurs in women after menopause. During menopause, the female ovaries stop producing the female hormone - estrogen, which allows for the maintenance of normal bone structure. The earlier menopause occurs in a woman, the higher her risk of fractures related to osteoporosis. Other factors that may increase the risk of fractures include:

• insufficient calcium and vitamin D in the diet;
• smoking or excessive alcohol consumption;
• insufficient physical activity (walking) or other intense exercises;
• a family history of osteoporosis.

A healthy lifestylewill also help to achieve the greatest benefits from treatment. This means:

• following a balanced diet rich in calcium and vitamin D,
• walking or other intense exercises,
• not smoking and limiting excessive alcohol consumption.

2. Important information before using Osagrand

When not to use Osagrand

• If the patient currently has or has had low calcium levels in the blood.In this case, consult a doctor.
• If the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

A side effect called jaw bone necrosis (damage to the jawbone) has been very rarely reported in patients treated with Osagrand for osteoporosis. Jaw bone necrosis may also occur after treatment has ended.
It is essential to take preventive measures to avoid the development of jaw bone necrosis, as it can be a painful and difficult-to-treat condition. To reduce the risk of jaw bone necrosis, appropriate precautions should be taken.
In patients receiving long-term ibandronate treatment, atypical fractures of long bones, such as the forearm (ulna) and tibia, have also been reported.
These fractures can occur with minimal trauma or without trauma, and some patients may experience pain at the fracture site before the fracture occurs.
Before starting treatment, the patient should inform the doctor or nurse (healthcare professional):

• if they have any oral or dental problems, such as poor dental condition, gum disease, or planned tooth extraction;
• if they do not receive routine dental care or have not had dental check-ups for a long time;
• if they smoke (which may increase the risk of dental problems);
• if they have been previously treated with bisphosphonates (used to treat or prevent bone diseases);
• if they are taking corticosteroids (e.g., prednisolone or dexamethasone);
• if they have been diagnosed with cancer.

The doctor may recommend a dental examination before starting Osagrand treatment.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If dental prostheses are used, ensure they fit properly. During dental treatment or before dental procedures (e.g., tooth extraction), inform the doctor and dentist that Osagrand is being taken.
If any oral or dental problems occur, such as tooth loosening, pain, or swelling, non-healing ulcers, or discharge, immediately contact the doctor and dentist, as these may be symptoms of jaw bone necrosis.
Some patients should be cautious when taking Osagrand.
Before starting Osagrand treatment, tell the doctor:

• if they currently have or have had kidney disease, kidney failure, or require dialysis, or if they have any other conditions that may affect the kidneys.
• if they have any mineral metabolism disorders (such as vitamin D deficiency).
• while taking Osagrand, they should take calcium and vitamin D supplements. If this is not possible, inform the doctor.
• if they have heart disease and the doctor has recommended fluid restriction.

In the group of patients treated with intravenous ibandronic acid, cases of severe, sometimes fatal, allergic reactions have been reported. If the patient experiences any of the following symptoms, such as shortness of breath or difficulty breathing, feeling of throat constriction, tongue swelling, dizziness, feeling of loss of consciousness, facial redness or swelling, rash on the body, nausea, and vomiting, they should immediately inform the doctor or nurse (see section 4).

Children and adolescents

Osagrand should not be used in children and adolescents under 18 years of age.

Osagrand and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

Osagrand is intended for postmenopausal women and should not be taken by women of childbearing age.
Osagrand should not be used during pregnancy or breastfeeding. Before taking this medicine, consult a doctor or pharmacist.

Driving and using machines

It is possible to drive and use machines, as Osagrand is not expected to affect or have a negligible effect on the ability to drive and use machines.
Osagrand contains less than 1 mmol of sodium (23 mg) per dose (3 ml),and is therefore considered a sodium-free medicine.

3. How to use Osagrand

The recommended dose of Osagrand for intravenous injection is 3 mg (1 ampoule) every 3 months.
The intravenous injection should be administered by a doctor or qualified/trained medical personnel. Do not administer injections yourself.
The solution for injection should be administered intravenously onlyand not in any other way.

Continuation of Osagrand treatment

To get the most benefit from treatment, it is essential that the patient receives injections every 3 months, as long as the doctor recommends. The therapeutic effect of Osagrand in osteoporosis occurs as long as the medicine is taken, even if the patient does not notice or feel the difference. Consult the doctor about the need to continue Osagrand treatment after 3-5 years of receiving it.
It is also necessary to take calcium and vitamin D supplements, as recommended by the doctor.

Using a higher dose of Osagrand than recommended

Decreased levels of calcium, phosphorus, or magnesium in the blood may occur. The doctor may take measures to correct these changes and may administer an injection containing these minerals.

Missing a dose of Osagrand

Make an appointment for the next injection as soon as possible. Then, return to receiving injections every 3 months from the date of the last injection.

4. Possible side effects

Like all medicines, Osagrand can cause side effects, although not everybody gets them.

Immediately inform the nurse or doctor if any of the following severe side effects occur, as immediate medical attention may be necessary:

Uncommon(may occur in less than 1 in 100 people):

• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth.

Rare(may occur in less than 1 in 1,000 people):

• itching, swelling of the face, lips, tongue, and throat, with difficulty breathing.
• persistent eye pain and inflammation (if prolonged).
• new pain, weakness, or discomfort in the thigh, hip, or groin area. These may be early symptoms indicating a possible atypical fracture of the thigh bone.

Very rare(may occur in less than 1 in 10,000 people):

• mouth or jaw pain or ulceration. These may be early symptoms of severe jaw problems (necrosis [dead bone tissue] in the jawbone).
• If the patient experiences ear pain, discharge from the ear, and/or ear infection, they should inform the doctor. These may be symptoms of bone damage in the ear.
• severe, potentially life-threatening allergic reactions (see section 2).
• severe skin reactions.

Other possible side effects

Common(may occur in less than 1 in 10 people):

• headache.
• stomach pain (may be caused by stomach inflammation) or abdominal pain, nausea, vomiting, diarrhea (loose stools), or constipation.
• muscle, joint, or back pain.
• feeling tired and exhausted.
• flu-like symptoms, including fever, chills, and shivering, discomfort, fatigue, bone pain, and muscle and joint pain. Consult the nurse or doctor if any of these symptoms become troublesome or last more than a few days.
• rash.

Uncommon(may occur in less than 1 in 100 people):

• vein inflammation.
• pain or injury at the injection site.
• bone pain.
• feeling weak.
• asthma attacks.

Rare(may occur in less than 1 in 1,000 people):

• hives.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Osagrand

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
The person administering the injection should dispose of any unused solution and discard the used ampoule in an appropriate container for this type of waste.

6. Package contents and other information

What Osagrand, 3 mg, solution for injection in an ampoule contains

• The active substance of Osagrand is ibandronic acid. One ampoule contains 3 mg of ibandronic acid in 3 ml of solution (as 3.375 mg of sodium ibandronate monohydrate).
• The other ingredients are: sodium chloride, glacial acetic acid, sodium acetate trihydrate, water for injection.

What Osagrand, 3 mg, solution for injection in an ampoule looks like and what the package contains

Osagrand, 3 mg, solution for injection is a clear solution without particles in an ampoule made of colorless glass (type I). The pH of the solution is 3.465 - 4.235, and the osmolality is between 270 and 310 mosmol/kg.
Each ampoule contains 3 ml of solution.
Pack sizes: 1 or 4 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, 102 37 Prague 10 Dolní Měcholupy, Czech Republic

Manufacturer:

Zentiva k.s., U kabelovny 130, 102 37 Prague 10 Dolní Měcholupy, Czech Republic
S.C. Zentiva, S.A, B-dul Theodor, Pallady nr.50, sector 3, 032266 Bucureşti, Romania
This medicine is authorized in the Member States of the European Economic Area under the following names:
Czech Republic, Poland: Osagrand
Romania, Lithuania, Latvia: Osagrand 3 mg

For more information about the medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:August 2024
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INFORMATION INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS

MEDICAL

To obtain detailed information, refer to the Summary of Product Characteristics.

Administration of Osagrand, 3 mg, solution for injection in an ampoule:

Osagrand, 3 mg, solution for injection in an ampoule should be administered by intravenous injection over 15-30 seconds.
The solution is irritating, so it should only be administered intravenously. If accidentally injected into the tissue around the vein, the patient may experience local irritation, pain, and inflammation at the injection site.
Osagrand, 3 mg, solution for injection in an ampoule should not be mixed with solutions containing calcium (such as Ringer's solution with lactate or calcium heparin) or other medicinal products for intravenous administration. When Osagrand is administered through a previously inserted intravenous infusion set, the previously administered fluids should only be either saline solution or 50 mg/ml (5%) glucose solution.

Missed dose:

In case of a missed dose, the injection should be administered as soon as possible. The next injections should be scheduled every 3 months from the date of the last injection.

Overdose:

There is no specific information on the treatment of ibandronic acid overdose.
Based on the knowledge of this group of compounds, it can be expected that intravenous overdose may cause hypocalcemia, hypophosphatemia, and hypomagnesemia, which may lead to paresthesia. In severe cases, it may be necessary to administer appropriate doses of calcium gluconate, potassium phosphate, or magnesium sulfate by intravenous infusion.

General information:

Osagrand, 3 mg, solution for injection in an ampoule, like other intravenously administered bisphosphonates, may cause transient decreases in serum calcium levels.
Before starting Osagrand treatment, hypocalcemia and other mineral and bone metabolism disorders should be assessed and effectively treated. All patients should receive calcium and vitamin D supplements.
Patients with concomitant diseases or using other medicinal products that may adversely affect the kidneys should be regularly monitored according to the best medical practices.
Any unused solution for injection and the used ampoule should be disposed of in accordance with local regulations.