Oxacilin Norameda

Leaflet attached to the packaging: patient information

Oxacillin Norameda, 1000 mg,

powder for solution for injection/infusion
Oxacillinum

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

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Oxacillin Norameda and what is it used for
• 2. Important information before using Oxacillin Norameda
• 3. How to use Oxacillin Norameda
• 4. Possible side effects
• 5. How to store Oxacillin Norameda
• 6. Contents of the pack and other information

1. What is Oxacillin Norameda and what is it used for

The active substance of Oxacillin Norameda is oxacillin, which belongs to a group of medicines called beta-lactam antibiotics, beta-lactamase-resistant penicillins.
Oxacillin works against susceptible bacteria that cause infections of the respiratory tract, skin, and bones. Oxacillin Norameda is also used in severe infections, such as endocarditis (inflammation of the inner surface of the heart), meningitis, and septicemia (bacteremia). It may also be used to prevent postoperative infections.
Oxacillin can also be used for other types of infections, as advised by a doctor.
The medicine is used in adults and children from birth to treat the following infections:

• Endocarditis
• Meningitis
• Pneumonia
• Joint infections
• Osteomyelitis (bone and bone marrow infection)
• Skin and soft tissue infections
• Bacteremia associated with or suspected to be associated with the above infections
• Prophylaxis of postoperative infections in:
• neurosurgery: craniotomy and internal cerebral spinal fluid shunt
• plastic and reconstructive surgery of varying complexity.

Consideration should be given to the guidelines for the proper use of antibiotics.

2. Important information before using Oxacillin Norameda

When not to use Oxacillin Norameda:

• if the patient is allergic to oxacillin, other beta-lactam antibiotics (penicillins and cephalosporins), or any of the other ingredients of this medicine (listed in section 6); Discontinue the medicine and inform the doctor if an allergic reaction occurs.

Warnings and precautions

Before starting treatment with Oxacillin Norameda, discuss it with your doctor.
Inform your doctor immediately if the patient experiences any symptoms of an allergic reaction during treatment.
Before using this medicine, inform your doctor if an allergic reaction has occurred during previous antibiotic treatment (even with a different class of antibiotics):
hives or other rash, itching, sudden swelling of the face and neck (angioedema) (see section 4.).
During antibiotic treatment, including Oxacillin Norameda, even several weeks after the end of treatment, diarrhea may occur. If diarrhea worsens or does not improve, or if blood or mucus appears in the stool, discontinue Oxacillin Norameda immediately. Do not take medications that block or slow down bowel movements and contact your doctor (see section 4).

Oxacillin Norameda and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including methotrexate (a medicine used to treat cancer or rheumatoid arthritis), probenecid (a medicine used to treat gout), or another antibiotic, including over-the-counter medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

Oxacillin Norameda should not be used during pregnancy unless it is absolutely necessary, as advised by a doctor.

Breastfeeding

Penicillins pass into breast milk in small amounts, and the amounts ingested are significantly less than therapeutic doses for newborns. Therefore, caution should be exercised when administering oxacillin to breastfeeding mothers. If the newborn experiences problems, such as diarrhea, skin rash, or thrush (a fungal infection), inform the doctor immediately, who will advise on what to do, as these may be caused by the effect of this medicine on the child's body.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

Oxacillin Norameda does not affect the ability to drive or use machines.

Oxacillin Norameda contains sodium

Each vial of the medicine contains 64 mg of sodium (the main component of common salt). This corresponds to 3.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Oxacillin Norameda?

Dosage

Oxacillin Norameda is a medicine for injection, administered by a healthcare professional intramuscularly or intravenously. The doctor will determine the appropriate dose for the patient.

Recommended dose:

Adults

Endocarditis (inflammation of the inner surface of the heart)
Infective endocarditis associated with native valve: 2 g intravenously every 4 hours or 3 g intravenously every 6 hours. Endocarditis associated with prosthetic valve: 2 g intravenously every 4 hours.
Total dose: 12 g/day.
Duration of treatment: In complicated right-sided endocarditis associated with native valve and left-sided endocarditis associated with native valve: 6 weeks. In uncomplicated right-sided endocarditis associated with native valve: 2 weeks. In endocarditis associated with prosthetic valve: at least 6 weeks.
Meningitis
2 g intravenously every 4 hours.
Total dose: 12 g/day
Duration of treatment: at least 2 weeks.
Pneumonia
2 g intravenously every 4-6 hours.
Total dose: 12 g/day
Duration of treatment: at least 5 days in outpatient pneumonia and 7 days in hospitalized pneumonia or ventilator-associated pneumonia; patients should be clinically stable and have normal vital signs before discontinuing treatment. Longer cycles may be necessary in severe pneumonia with necrosis; pneumonia complicated by meningitis, endocarditis, or other deep-seated infections; pneumonia caused by non-fermenting Gram-negative bacteria; or complicated pneumonia caused by less common pathogens (e.g., Burkholderia pseudomallei, Mycobacterium tuberculosisor endemic fungi).
Joint infection
2 g intravenously every 4-6 hours.
Total dose: 12 g/day
Duration of treatment: 4-6 weeks.
Osteomyelitis (bone and bone marrow infection)
1.5 to 2 g intravenously every 4-6 hours.
Total dose: 12 g/day
Duration of treatment: 4-6 weeks.
Skin or soft tissue infection
Localized post-surgical wound infection: 2 g intravenously every 6 hours.
Necrotizing skin and soft tissue infections: 1 to 2 g intravenously every 4 hours.
Total dose: 12 g/day
Duration of treatment: The duration of treatment for most bacterial skin or soft tissue infections should be 7-14 days. For necrotizing fasciitis, 2-3 weeks of therapy are recommended. For erysipelas and cellulitis, the recommended duration of antimicrobial therapy is 5 days, but treatment should be extended if the infection does not improve within this period. For necrotizing infections, antimicrobial therapy should be continued until further wound cleaning is not necessary, the patient's clinical condition improves, and the patient has been afebrile for 48 to 72 hours.
Bacteremia
2 g intravenously every 4-6 hours.
Total dose: 12 g/day
Duration of treatment: 2-6 weeks
Prophylaxis of postoperative infections
2 g intravenously within 60 minutes before the first incision, and then 2 g intravenously every 4 hours, if necessary
Total dose: 12 g/day
Duration of treatment: should not exceed 48 hours

Use in children and adolescents

Endocarditis
Children over 1 year: 200 mg/kg per day intravenously in divided doses every 4 to 6 hours.
Maximum dose: 12 g/day.
Maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: At least 4 to 6 weeks.
Meningitis
Newborns 0 to 7 days: 25 mg/kg intravenously every 8 to 12 hours.
Newborns 8 to 28 days: 50 mg/kg intravenously every 6 to 8 hours.
Infants, children, and adolescents: 50 mg/kg intravenously every 6 hours.
Maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: at least 2 weeks.
In the case of newborns with very low birth weight (<2000 g), smaller doses and longer intervals between may be recommended.
Pneumonia
Infants and children over 3 months: 150-200 mg/kg per day intravenously or intramuscularly in divided doses every 6 to 8 hours.
Maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: 5-14 days
Osteomyelitis (bone and bone marrow infection)
Infants and children over 3 months: 150-200 mg/kg per day intravenously in divided doses every 4 to 6 hours.
Duration of treatment: 3-4 weeks. Longer treatment duration may be required in cases of disease caused by methicillin-resistant Staphylococcus aureus(MRSA) or Salmonella, infections of the pelvis or spine, severe and/or complicated infections, or slow response to treatment.
Joint infection
Infants and children over 3 months: 150-200 mg/kg per day intravenously in divided doses every 4 to 6 hours.
Maximum dose, calculated based on body weight, should not exceed 12 g per day.
Duration of treatment: The total duration of treatment, intravenous plus oral, should be approximately 2-3 weeks. Longer treatment duration may be necessary (up to 4-6 weeks) in cases of MRSA infection or infection associated with the presence of Panton-Valentine leukocidin (PVL), newborns and young infants, slow and/or poor response to treatment, or complications or involvement of the pelvis or spine.
Skin or soft tissue infection
Infants and children over 1 month: 100-150 mg/kg per day intravenously in divided doses every 6 hours. In the case of necrotizing infection, 200 mg/kg per day intravenously in divided doses every 6 hours.
Duration of treatment: The duration of treatment for most bacterial skin or soft tissue infections should be 7-14 days. For necrotizing fasciitis, 2-3 weeks of therapy are recommended. For erysipelas and cellulitis, the recommended duration of antimicrobial therapy is 5 days, but treatment should be extended if the infection does not improve within this period. For necrotizing infections, antimicrobial therapy should be continued until further wound cleaning is not necessary, the patient's clinical condition improves, and the patient has been afebrile for 48 to 72 hours.
Bacteremia

Maximum dose: 12 g/day.
Duration of treatment: 2-6 weeks
Prophylaxis of postoperative infections
50 mg/kg intravenously within 60 minutes before the first incision, and then 50 mg/kg intravenously every 4 hours, if necessary
Maximum dose, calculated based on body weight, should not exceed 12 g per day
Duration of treatment: should not exceed 48 hours

Elderly

When administered intravenously, especially in elderly patients, caution should be exercised due to the possibility of phlebitis.

Use in patients with renal impairment

In patients with severe renal impairment, dose adjustment is necessary.
The doctor should consider creatinine clearance and monitor the concentration of the medicine.
Treatment should be continued for at least 48 hours after the disappearance of objective and subjective symptoms of infection.

Method of administration

Oxacillin is administered intramuscularly, by intravenous injection, or as an intravenous infusion, after dissolution in a compatible solvent.

Duration of treatment

To be effective, this antibiotic must be used regularly in the prescribed doses and for as long as the doctor has prescribed. The disappearance of fever or any other symptom does not mean complete recovery. Any feeling of fatigue is not caused by antibiotic therapy but by the infection itself. Reducing the dose or discontinuing treatment will not affect this feeling and will delay recovery.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should contact their doctor or healthcare professional immediately – urgent medical attention may be required:

• anaphylactic shock - difficulty breathing, low blood pressure, rapid pulse (very rare), severe watery diarrhea with abdominal pain and possible presence of blood and mucus (very rare) (see section 2. Warnings and precautions),
• allergic reaction (frequency not known), such as skin rash, itching, or hives, breathing problems, swelling of the face and neck,
• fever, unusual bleeding, seizures (frequency not known).

If the patient experiences any of the following side effects, they should contact their doctor as soon as possible:

contact a doctor as soon as possible:

Rare side effects (less than 1 in 1000 people)

• increased activity of certain liver enzymes (aminotransferases, alkaline phosphatase), hepatitis with jaundice

Side effects of unknown frequency

• insufficient number of red blood cells (anemia) or certain white blood cells (leukopenia) or blood cells used for blood clotting (thrombocytopenia) that resolve after discontinuation of treatment

increased number of certain white blood cells in the blood (eosinophilia)

• nausea, vomiting, diarrhea
• kidney disease (acute interstitial nephritis)
• fatigue
• neurological disorders, such as altered consciousness, confusion, abnormal movements, involuntary muscle contractions, reported after administration of high doses of oxacillin, especially in cases of renal impairment.
• fungal superinfection (vaginal candidiasis)

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
Phone: 22 49-21-301,
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Oxacillin Norameda

Keep the medicine out of sight and reach of children.
This medicinal product does not require special storage conditions.
Do not use this medicine after the expiry date stated on the carton, vial, or after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oxacillin Norameda contains

• The active substance of the medicine is oxacillin: each vial contains 1000 mg of oxacillin (as oxacillin sodium monohydrate)
• The other ingredient is disodium phosphate

What Oxacillin Norameda looks like and contents of the pack

Oxacillin Norameda is a white or almost white powder in a vial made of colorless glass (type III), closed with a gray rubber stopper and protected with an aluminum flip-off cap.
Packaging: cardboard box containing 1, 10, 25, or 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

UAB Norameda
Meistrų g. 8A,
02189 Vilnius,
Lithuania

Contact

Norameda Polska Sp. z o.o.
ul. Kilińskiego 20, 05-500 Piaseczno, Poland
Phone: +48 504 278 778
e-mail: [email protected]

Manufacturer

Mitim S.r.l.
Via Giovanni Battista Cacciamali 34-38
Brescia
BS, 25125
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Oxacillin AVMC
Slovakia
Oxacillin AVMC
Poland
Oxacillin Norameda
Estonia
Oxacillin Auxilia
Italy
Oxciva
Date of last revision of the leaflet:03/2025

Information intended for healthcare professionals only:

Reconstitution and dilution

Intramuscular injection
To prepare a solution for injection for intramuscular administration, add 5.7 mL of water for injection or 0.9% sodium chloride solution to the vial.
Shake the vial until the solution is clear. The solution should be administered intramuscularly immediately or within 8 hours if stored at a temperature of 2-8°C.
Intravenous injection
In the case of intravenous administration, add 10 mL of water for injection or 10 mL of 0.9% sodium chloride solution. Shake the vial until the solution is clear.
The solution should be administered slowly intravenously over 10 minutes. The solution should be used immediately after preparation or within 8 hours if stored at a temperature of 2-8°C.
The prepared solution can be further diluted with one of the following infusion solutions:

• isotonic sodium chloride solution
• 5% glucose solution in water for injection
• 5% glucose solution in isotonic sodium chloride solution
• 10% D-fructose solution in water for injection
• 10% D-fructose solution in isotonic sodium chloride solution
• Ringer's solution for infusion with lactate
• sodium chloride and potassium chloride injection solution with lactate
• 10% invert sugar solution in water for injection
• 10% invert sugar solution in isotonic sodium chloride solution
• 10% invert sugar solution + 0.3% potassium chloride in water for injection Chemical and physical stability (after reconstitution for injection or after reconstitution and dilution for infusion, as described above) has been demonstrated for 6 hours at room temperature for the following infusion diluents: isotonic sodium chloride solution, 5% glucose solution in water for injection, and 5% glucose solution in isotonic sodium chloride solution. Other solvents have shown stability for 8 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.