GERALGINE-M 1 g / 2 ml IMIIV ampoule
It is applied intramuscularly or intravenously.
Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.
In this Instructions for Use:
1. What is GERALGINE-M and what is it used for?
2. Things to consider before using GERALGINE-M
3. How to use GERALGINE-M?
4. What are the possible side effects?
5. How to store GERALGINE-M
Headings are included.
1. GERALGINE-M nedir ve ne için kullanılır?
GERALGINE-M contains metamizole sodium active ingredient. There is 1 g of metamizole sodium in one ampoule. An ampoule contains 2 ml of solution and 1 ml of the solution contains 500 mg of active substance. It is available in packages containing 10, 50 and 100 ampoules.
There is also a syrup form of GERALGINE-M * on the market.
GERALGINE-M is a drug with pain relieving, antipyretic and spasm (convulsion) resolving effects.
Your doctor may have prescribed this form of GERALGINE-M, which is administered intravenously or intramuscularly, because you have severe or persistent pain or fever and to relieve these symptoms in a short time.
2. Things to consider before using ASEC
DO NOT USE GERALGINE-M in the following situations
- If you are allergic (hypersensitive) to metamizole sodium active substance contained in the drug or to one of the other substances or to drugs that are included in the groups called pyrazolone (e.g. phenazone, propifenazone) or pyrazolidine (e.g. phenylbutazone, oxyphenbutazone) or to one of these substances. if you have developed a reaction in your blood that is manifested by an abnormal decrease of cells called granulocytes
- If you have impaired bone marrow function (e.g. if you have been treated for cancer) or you have a disease in your body system responsible for blood cell production
- Against pain relievers such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen; If you have developed severe allergic reactions such as inability to breathe, hives with excessive itching and redness of the skin, inflammation of the nasal mucosa, swelling of the skin or respiratory tract
- If you have a disease called acute intermittent hepatic porphyria (there may be a risk of initiating porphyria attacks.)
If you have a congenital glucose-6-phosphate dehydrogenase deficiency
- It should not be administered intravenously or intramuscularly in patients with hypotension (low blood pressure).
If you have a baby under three months of age or less than 5 kg
-GERALGINE-M should not be administered intravenously in babies between 3 and 11 months.
USE GERALGINE-M CAREFULLY in the following situations
Intravenous or intramuscular administration of GERALGINE-M carries a higher risk in terms of serious allergic reactions.
If fever, chills, sore throat, mouth sores occur during treatment, stop the treatment immediately and apply to the emergency service of the nearest hospital. This disorder (agranulocytosis), which is characterized by the excessive reduction of cells called granulocytes in the blood, which have an important role for the body's defense, is an allergic-origin event that lasts at least one week and concerns the immune system. These reactions are very rare, but can be severe and life-threatening and result in death. These are not dose dependent and can occur at any time during treatment.
During treatment, general malaise, infection, persistent fever, bruises, bleeding, and pale skin may be seen. These symptoms may have occurred due to a decrease in the number of all blood cells (pancytopenia). If you have one or more of these symptoms, stop the treatment and consult your doctor immediately. In this case, your doctor will follow you through blood tests until your blood cell count returns to normal.
Especially, patients with the following conditions are special in terms of possible sudden and severe allergic reactions to metamizole. they are at risk. Your doctor may ask you questions to find out if you are at such a risk. If GERALGINE-M is to be used under such risky conditions, strict medical supervision is required and the conditions for emergency treatment must be ready.
• Patients with bronchial asthma,
During treatment, life-threatening skin reactions such as Stevens-Johnson syndrome (water-filled blisters on your skin or severe skin reaction causing widespread redness and peeling) and toxic epidermal necrolysis (a serious disease with fluid-filled blisters on the skin) may occur. If you develop an increasingly severe skin rash, usually accompanied by fluid-filled blisters or injuries in the mouth, discontinue the treatment and consult your doctor immediately. These symptoms mostly occur in the first weeks of treatment. If you have these symptoms, do not use GERALGLN again.
Metamizole administration alone may cause severe hypertension (isolated hypotensive reaction). Therefore, it is recommended that GERALGINE-M be administered very carefully and under medical supervision in the following situations:
Patients with pre-existing low blood pressure and disorders that may affect blood pressure control (patients with excessive fluid loss, circulatory unbalanced, circulatory failure)
• Patients with renal or hepatic impairment (the rate of metamizole excretion from the body decreases.)
If these warnings apply to you, even at any time in the past, please
Consult your doctor.
This form of GERALGINE-M is not taken orally. It is administered intravenously or intramuscularly.
Consult your doctor or pharmacist before using this medication.
You should not use GERALGINE-M during the first and last trimester of your pregnancy. Consult your doctor about using GERALGINE-M in the second trimester of your pregnancy and use it only if your doctor deems appropriate.
If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Breast-feeding
Do not breastfeed your baby for 48 hours after using GERALGINE-M.
Vehicle and machine use
Metamizole may impair concentration and reaction ability when used in high doses. Especially if you have consumed alcohol together, do not drive or use machinery.
Important information about some of the ingredients of GERALGINE-M
It does not contain an auxiliary substance that requires special measures.
Use with other drugs
- GERALGINE-M, which is used to suppress the immune system after organ transplants, may decrease cyclosporine levels when used together with drugs called cyclosporine. Regular checks are required.
- When GERALGINE-M is used in combination with chlorpromazine, which is used in the treatment of serious mental illnesses, an excessive decrease in body temperature (hypothermia) may occur.
- GERALGINE-M group of drugs, oral anticoagulants (oral blood thinners), captopril (high blood pressure drug), lithium (a drug used in the treatment of manic depressive illness) methotrexate (a drug used in the treatment of cancer, rheumatism or psoriasis) ) and triamterin (a diuretic drug). Although the effect of NOVALGIN on these drugs is unknown, care should be taken when using them together.
- When GERALGINE-M is used in combination with a drug called methotrexate used in the treatment of cancer, rheumatism or psoriasis, it may increase the harmful effect of methotrexate on the blood. These two drugs should not be used together.
-GERALGINE-M is soluble in 5% glucose, 0.9% NaCl or Ringer's lactate solution. However, these solutions should be applied immediately because their stability is limited.
- Due to the possibility of incompatibility, metamizole sodium should not be administered with other injectable drugs.
3. How to use ASEC?
Instructions for appropriate use and dose / frequency of administration
GERALGINE-M ampoule is applied under the supervision of a doctor.
Your doctor will determine the dose of your medicine depending on your illness and will apply it to you.
GERALGINE-M is generally used as:
In teenagers and adults aged 15 and over:
One-time dose to be administered intravenously or intramuscularly is 2-5 ml (1 GERALGINE-M ampoule or 1 GERALGINE-M ampoule 5 ml).
The maximum daily dose can be increased to 10 ml (5 g) (5 GERALGINE-M ampoules 2 ml or 2 GERALGINE-M ampoules 5 ml).
Application way and method:
GERALGINE-M ampoule is administered by a healthcare professional trained in intravenous and intramuscular drug administration.
If there is solution in the extraction, gently tap or shake the ampoule to let it flow down.
OPENING THE BULB
Hold the bulb with the point up.
Holding the bulb with the point up, break the pull down by pulling it down.
Your doctor will determine the dose and method of administration of the drug based on your child's age, body weight and disease.
Use in the elderly
In elderly patients and patients with poor general conditions, your doctor will adjust the dose by considering possible deterioration in kidney and liver functions.
Special use cases
Kidney / liver failure
Your doctor will determine the dose of your medication based on your illness and the severity of your kidney / liver problems.
If you have an impression that the effect of GERALGINE-M is too strong or too weak, talk to your doctor or pharmacist.
Since GERALGINE-M will be used under the supervision of a doctor, necessary measures will be taken to prevent such a situation from developing. In such a situation, appropriate treatment will be done.
If you have used more than you should use from GERALGINE-M, talk to a doctor or pharmacist.
If you forgot to use GERALGINE-M
Since GERALGINE-M will be used under the supervision of a doctor, necessary measures will be taken to prevent such a situation from developing.
Do not take a double dose to make up for forgotten doses.
Effects that may occur when treatment with GERALGINE-M is terminated
If you stop using GERALGINE-M without your doctor's approval, your pain may start again or your fever may rise.
4. What are the possible side effects?
Like all medicines, people who are sensitive to the ingredients of GERALGINE-M may have side effects.
If any of the following occur, stop using GERALGINE-M and IMMEDIATELY inform your doctor or go to the nearest emergency department:
• If rash, skin rash or other symptoms of skin or eyes, itching, shortness of breath or high fever occur.
If you become prone to bleeding, pinhead-size bleeding under your skin
• If you have water-filled blisters or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) causing widespread redness and peeling.
These are all very serious side effects. If you have one of these, you have a serious allergy to GERALGINE-M.
You may need urgent medical attention or hospitalization.
All of these very serious side effects are very rare.
If you notice any of the following, immediately report to your doctor or contact the emergency department of your nearest hospital:
All these are serious side effects. Emergency medical attention may be required.
Serious side effects are very rare.
If you notice any of the following, tell your doctor:
Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.
How to store GERALGINE-M
Keep GERALGINE-M in places where children can not see or reach and in its package. Store at room temperature below 25 ° C and in its original package.
Use in accordance with expiration dates.
GERALGINE-M 1 g / 2 ml IMIIV ampoule
It is applied intramuscularly or intravenously.
Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.
In this Instructions for Use:
1. What is GERALGINE-M and what is it used for?
2. Things to consider before using GERALGINE-M
3. How to use GERALGINE-M?
4. What are the possible side effects?
5. How to store GERALGINE-M
Headings are included.
1. GERALGINE-M nedir ve ne için kullanılır?
GERALGINE-M contains metamizole sodium active ingredient. There is 1 g of metamizole sodium in one ampoule. An ampoule contains 2 ml of solution and 1 ml of the solution contains 500 mg of active substance. It is available in packages containing 10, 50 and 100 ampoules.
There is also a syrup form of GERALGINE-M * on the market.
GERALGINE-M is a drug with pain relieving, antipyretic and spasm (convulsion) resolving effects.
Your doctor may have prescribed this form of GERALGINE-M, which is administered intravenously or intramuscularly, because you have severe or persistent pain or fever and to relieve these symptoms in a short time.
2. Things to consider before using ASEC
DO NOT USE GERALGINE-M in the following situations
- If you are allergic (hypersensitive) to metamizole sodium active substance contained in the drug or to one of the other substances or to drugs that are included in the groups called pyrazolone (e.g. phenazone, propifenazone) or pyrazolidine (e.g. phenylbutazone, oxyphenbutazone) or to one of these substances. if you have developed a reaction in your blood that is manifested by an abnormal decrease of cells called granulocytes
- If you have impaired bone marrow function (e.g. if you have been treated for cancer) or you have a disease in your body system responsible for blood cell production
- Against pain relievers such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen; If you have developed severe allergic reactions such as inability to breathe, hives with excessive itching and redness of the skin, inflammation of the nasal mucosa, swelling of the skin or respiratory tract
- If you have a disease called acute intermittent hepatic porphyria (there may be a risk of initiating porphyria attacks.)
If you have a congenital glucose-6-phosphate dehydrogenase deficiency
- It should not be administered intravenously or intramuscularly in patients with hypotension (low blood pressure).
If you have a baby under three months of age or less than 5 kg
-GERALGINE-M should not be administered intravenously in babies between 3 and 11 months.
USE GERALGINE-M CAREFULLY in the following situations
Intravenous or intramuscular administration of GERALGINE-M carries a higher risk in terms of serious allergic reactions.
If fever, chills, sore throat, mouth sores occur during treatment, stop the treatment immediately and apply to the emergency service of the nearest hospital. This disorder (agranulocytosis), which is characterized by the excessive reduction of cells called granulocytes in the blood, which have an important role for the body's defense, is an allergic-origin event that lasts at least one week and concerns the immune system. These reactions are very rare, but can be severe and life-threatening and result in death. These are not dose dependent and can occur at any time during treatment.
During treatment, general malaise, infection, persistent fever, bruises, bleeding, and pale skin may be seen. These symptoms may have occurred due to a decrease in the number of all blood cells (pancytopenia). If you have one or more of these symptoms, stop the treatment and consult your doctor immediately. In this case, your doctor will follow you through blood tests until your blood cell count returns to normal.
Especially, patients with the following conditions are special in terms of possible sudden and severe allergic reactions to metamizole. they are at risk. Your doctor may ask you questions to find out if you are at such a risk. If GERALGINE-M is to be used under such risky conditions, strict medical supervision is required and the conditions for emergency treatment must be ready.
• Patients with bronchial asthma,
During treatment, life-threatening skin reactions such as Stevens-Johnson syndrome (water-filled blisters on your skin or severe skin reaction causing widespread redness and peeling) and toxic epidermal necrolysis (a serious disease with fluid-filled blisters on the skin) may occur. If you develop an increasingly severe skin rash, usually accompanied by fluid-filled blisters or injuries in the mouth, discontinue the treatment and consult your doctor immediately. These symptoms mostly occur in the first weeks of treatment. If you have these symptoms, do not use GERALGLN again.
Metamizole administration alone may cause severe hypertension (isolated hypotensive reaction). Therefore, it is recommended that GERALGINE-M be administered very carefully and under medical supervision in the following situations:
Patients with pre-existing low blood pressure and disorders that may affect blood pressure control (patients with excessive fluid loss, circulatory unbalanced, circulatory failure)
• Patients with renal or hepatic impairment (the rate of metamizole excretion from the body decreases.)
If these warnings apply to you, even at any time in the past, please
Consult your doctor.
This form of GERALGINE-M is not taken orally. It is administered intravenously or intramuscularly.
Consult your doctor or pharmacist before using this medication.
You should not use GERALGINE-M during the first and last trimester of your pregnancy. Consult your doctor about using GERALGINE-M in the second trimester of your pregnancy and use it only if your doctor deems appropriate.
If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Breast-feeding
Do not breastfeed your baby for 48 hours after using GERALGINE-M.
Vehicle and machine use
Metamizole may impair concentration and reaction ability when used in high doses. Especially if you have consumed alcohol together, do not drive or use machinery.
Important information about some of the ingredients of GERALGINE-M
It does not contain an auxiliary substance that requires special measures.
Use with other drugs
- GERALGINE-M, which is used to suppress the immune system after organ transplants, may decrease cyclosporine levels when used together with drugs called cyclosporine. Regular checks are required.
- When GERALGINE-M is used in combination with chlorpromazine, which is used in the treatment of serious mental illnesses, an excessive decrease in body temperature (hypothermia) may occur.
- GERALGINE-M group of drugs, oral anticoagulants (oral blood thinners), captopril (high blood pressure drug), lithium (a drug used in the treatment of manic depressive illness) methotrexate (a drug used in the treatment of cancer, rheumatism or psoriasis) ) and triamterin (a diuretic drug). Although the effect of NOVALGIN on these drugs is unknown, care should be taken when using them together.
- When GERALGINE-M is used in combination with a drug called methotrexate used in the treatment of cancer, rheumatism or psoriasis, it may increase the harmful effect of methotrexate on the blood. These two drugs should not be used together.
-GERALGINE-M is soluble in 5% glucose, 0.9% NaCl or Ringer's lactate solution. However, these solutions should be applied immediately because their stability is limited.
- Due to the possibility of incompatibility, metamizole sodium should not be administered with other injectable drugs.
3. How to use ASEC?
Instructions for appropriate use and dose / frequency of administration
GERALGINE-M ampoule is applied under the supervision of a doctor.
Your doctor will determine the dose of your medicine depending on your illness and will apply it to you.
GERALGINE-M is generally used as:
In teenagers and adults aged 15 and over:
One-time dose to be administered intravenously or intramuscularly is 2-5 ml (1 GERALGINE-M ampoule or 1 GERALGINE-M ampoule 5 ml).
The maximum daily dose can be increased to 10 ml (5 g) (5 GERALGINE-M ampoules 2 ml or 2 GERALGINE-M ampoules 5 ml).
Application way and method:
GERALGINE-M ampoule is administered by a healthcare professional trained in intravenous and intramuscular drug administration.
If there is solution in the extraction, gently tap or shake the ampoule to let it flow down.
OPENING THE BULB
Hold the bulb with the point up.
Holding the bulb with the point up, break the pull down by pulling it down.
Your doctor will determine the dose and method of administration of the drug based on your child's age, body weight and disease.
Use in the elderly
In elderly patients and patients with poor general conditions, your doctor will adjust the dose by considering possible deterioration in kidney and liver functions.
Special use cases
Kidney / liver failure
Your doctor will determine the dose of your medication based on your illness and the severity of your kidney / liver problems.
If you have an impression that the effect of GERALGINE-M is too strong or too weak, talk to your doctor or pharmacist.
Since GERALGINE-M will be used under the supervision of a doctor, necessary measures will be taken to prevent such a situation from developing. In such a situation, appropriate treatment will be done.
If you have used more than you should use from GERALGINE-M, talk to a doctor or pharmacist.
If you forgot to use GERALGINE-M
Since GERALGINE-M will be used under the supervision of a doctor, necessary measures will be taken to prevent such a situation from developing.
Do not take a double dose to make up for forgotten doses.
Effects that may occur when treatment with GERALGINE-M is terminated
If you stop using GERALGINE-M without your doctor's approval, your pain may start again or your fever may rise.
4. What are the possible side effects?
Like all medicines, people who are sensitive to the ingredients of GERALGINE-M may have side effects.
If any of the following occur, stop using GERALGINE-M and IMMEDIATELY inform your doctor or go to the nearest emergency department:
• If rash, skin rash or other symptoms of skin or eyes, itching, shortness of breath or high fever occur.
If you become prone to bleeding, pinhead-size bleeding under your skin
• If you have water-filled blisters or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) causing widespread redness and peeling.
These are all very serious side effects. If you have one of these, you have a serious allergy to GERALGINE-M.
You may need urgent medical attention or hospitalization.
All of these very serious side effects are very rare.
If you notice any of the following, immediately report to your doctor or contact the emergency department of your nearest hospital:
All these are serious side effects. Emergency medical attention may be required.
Serious side effects are very rare.
If you notice any of the following, tell your doctor:
Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.
How to store GERALGINE-M
Keep GERALGINE-M in places where children can not see or reach and in its package. Store at room temperature below 25 ° C and in its original package.
Use in accordance with expiration dates.
