INTRAZOLINA 1000 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION AND FOR INFUSION
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How to use INTRAZOLINA 1000 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION AND FOR INFUSION
Introduction
Package Leaflet: Information for the User
INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
Cefazolin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Contents of the package leaflet:
- What INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion is and what it is used for
- What you need to know before you use INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
- How to use INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
- Possible side effects
- Storage of INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
- Contents of the pack and other information
1. What INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion is and what it is used for
This medicinal product belongs to a group of antibiotics called cephalosporins. Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medicinal product. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste. |
INTRAZOLINA 1,000 mg is used to treat the following bacterial infections:
- Respiratory infections
- Urinary infections
- Infections of the skin and soft tissues
- Infections of the gallbladder and bile ducts
- Infections of bones and joints
- Heart infections
- Infection caused by the passage of bacteria into the blood (septicemia)
- In the prevention of infections in surgery
2. Before using INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
Do not use INTRAZOLINA 1,000 mg
- If you are allergic (hypersensitive) to cefazolin, other cephalosporins, or any of the other components of INTRAZOLINA 1,000 mg.
Warnings and precautions
- If you experience intense and prolonged diarrhea, it may be due to a special type of colitis called pseudomembranous colitis, which can be severe. In this case, your doctor will suspend the administration of cefazolin and initiate appropriate treatment.
- If you undergo prolonged treatment with INTRAZOLINA, other infections (superinfections) may appear due to the overgrowth of some organisms such as Candida.
- If you have kidney failure, your doctor may need to adjust the dose of cefazolin you receive.
- If you are going to have a blood test, inform the healthcare staff that you are being treated with this medicinal product, as cefazolin may interfere with the results.
Using INTRAZOLINA with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
INTRAZOLINA must not be administered simultaneously with:
- Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol
- Medicines that make the blood more fluid (anticoagulants)
- Probenecid
- Medicines toxic to the kidneys
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
In case of pregnancy, your doctor will decide whether to use this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
In case of breastfeeding, your doctor will decide whether to use this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Cefazolin generally does not affect the ability to drive vehicles and use machines.
INTRAZOLINA 1,000 mg contains sodium.
Patients on low-sodium diets should note that this medicinal product contains 51 mg (2.22 mmol) of sodium per dose.
3. How to use INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
Follow exactly the administration instructions for this medicinal product indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicinal product can be administered by intramuscular injection or by slow intravenous injection.
Remember that administration must be carried out by medical personnel.
Remember to request the administration of your medicine.
Your doctor will indicate the appropriate dose and determine the duration of your treatment; do not stop it before finishing or prolong it.
A dose reduction may be necessary if you have any kidney or liver impairment. In such cases, inform your doctor so that they can adjust the dose accordingly.
The recommended dose is:
Adults and adolescents (12 to 18 years):for mild infections, 500 mg every 8 hours; for moderate to severe infections, 500 mg to 1 g every 6 or 8 hours; for more severe infections, 1 to 1.5 g every 6 hours.
Pediatric population (over 1 year and under 12 years) and infants (over 1 month and under 12 months):a total daily dose of 25 to 50 mg per kg of body weight, divided into three or four equal doses, is effective in most mild to moderate infections. The total daily dose should not exceed 100 mg/kg, even in cases of severe infections.
If you use more INTRAZOLINA 1,000 mg than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount used.
If you forget to use INTRAZOLINA 1,000 mg
Do not use a double dose to make up for forgotten doses.
If you stop treatment with INTRAZOLINA 1,000 mg
Do not stop treatment before finishing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, they may worsen.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, INTRAZOLINA 1,000 mg can cause side effects, although not everybody gets them.
The following side effects have been reported according to the frequencies detailed below:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from the available data
Infections and infestations:
Genital infections.
Blood and lymphatic system disorders:
Decrease in the number of white blood cells, red blood cells, and platelets.
Immune system disorders:
Most commonly, the appearance of skin lesions that can have a varied appearance. Other possible reactions are itching, swelling of the face, difficulty breathing.
Nervous system disorders:
Dizziness, discomfort, fatigue, difficulty falling asleep, nightmares, weakness, and convulsive crises may occur.
Gastrointestinal disorders:
Nausea, loss of appetite, vomiting, diarrhea, mouth ulcers, and anal itching.
Hepatobiliary disorders:
Transient elevation of some enzymes (transaminases), rarely hepatitis, and yellowing of the skin.
Skin and subcutaneous tissue disorders:
Itching in the genital area.
Renal and urinary disorders:
Increased urea in the blood, which may indicate poor kidney function, rarely kidney inflammation.
General disorders and administration site conditions:
Pain at the injection site and inflammation of the vein at the injection site.
If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
5. Storage of INTRAZOLINA 1,000 mg powder and solvent for solution for injection and infusion
Keep this medicinal product out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not store above 25°C.
The reconstituted solution with the solvent is stable for 8 hours at a temperature not exceeding 25°C and for 24 hours if stored in the refrigerator (2-8°C).
Do not use INTRAZOLINA 1,000 mg after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.
6. Contents of the pack and other information
Composition of INTRAZOLINA 1,000 mg
The active substance is cefazolin.
Each vial contains 1,000 mg of cefazolin (as cefazolin sodium). The other components are water for injections.
Appearance and packaging of the product
INTRAZOLINA 1,000 mg is presented as a white or almost white powder, or slightly yellowish, and solvent for solution for injection. It is presented in packs with 1 vial of 1,000 mg of cefazolin powder and 1 ampoule of 4 ml of water for injections as solvent, and clinical packs with 100 vials and 100 ampoules of solvent.
Other presentations
INTRAZOLINA 500 mg powder and solvent for solution for injection and infusion: pack with 1 vial + 1 ampoule of 2 ml of water for injections. Clinical pack with 100 vials + 100 ampoules.
Not all pack sizes may be marketed.
Marketing authorisation holder
LDP-LABORATORIOS TORLAN, S.A.
Ctra. de Barcelona, 135-B
08290 Cerdanyola del Vallès
Barcelona
Manufacturer
LDP-LABORATORIOS TORLAN, S.A.
Ctra. de Barcelona, 135-B
08290 Cerdanyola del Vallès
Barcelona
or
- BRAUN MEDICAL, S.A.
Huelma, 5. Poligono Industrial Los Olivares. (Jaen) - 23009 - Spain
or
LABORATORIOS INIBSA, S.A
Ctra Sabadell-Granollers, km 14,5. (Llissa de Vall) - 08185 - Spain
Date of last revision of this leaflet:November 2011
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Warning: For use exclusively by a healthcare professional
This information is intended only for doctors or healthcare professionals:
- Stability of the reconstituted INTRAZOLINA solution:
After reconstitution, INTRAZOLINA can be stored for up to 3 hours at a temperature below +25°C and up to 6 hours between +2 and +8°C.
The slightly yellowish color of the solution does not indicate a change in the efficacy of the antibiotic or its tolerance. Solutions with a yellowish-brown or brown color should not be administered.
The stability of the INTRAZOLINA solution at a concentration of 5 mg/ml to 10 mg/ml is satisfactory in the following infusion liquids:
- Sodium chloride 0.9%
- Glucose 5% or 10%
- Glucose 5% in Ringer's lactate
- Sodium chloride 0.9% and glucose 5%
- Sodium chloride 0.45% and glucose 5%
- Ringer's lactate
- Fructose 5% or 10% in water for injection
- How to prepare this medicinal product
INTRAZOLINA 1,000 mg will be administered according to the following instructions:
Intravenous administration
Intrazolina can be administered by direct intravenous injection or by continuous or intermittent infusion.
For direct intravenous injection (bolus):
Intravenous injection: 1,000 mg reconstituted and diluted in 10 ml of water for injection. The solution is injected slowly over 3 to 5 minutes (it should not be administered in less than three minutes).
For continuous or intermittent intravenous infusion:
Intrazolina can be administered through the main infusion systems for liquids, controlling the infusion rate, or in a second infusion bag. The reconstitution of 1,000 mg of cefazolin can be performed with its solvent and then diluted in 50 to 100 ml of one of the following intravenous solutions:
- Sodium chloride 0.9%
- Glucose 5% or 10%
- Glucose 5% in Ringer's lactate
- Sodium chloride 0.9% and glucose 5%
- Sodium chloride 0.45% and glucose 5%
- Ringer's lactate
- Fructose 5% or 10% in water for injection
Intramuscular administration
For intramuscular injection, INTRAZOLINA 1,000 mg is reconstituted with the solvent from the accompanying ampoule (4 ml of water for injections). Shake well until dissolved. Cefazolin should be injected into a area of large muscle mass.
Intramuscular cefazolin causes pain at the injection site.
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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