1 g resp. 2 g powder for solution for injection / infusion, ceftriaxone solution
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.
This leaflet contains information about:
1. What Ceftriaxone Villerton is and what it is used for
2. What you need to know before you get Ceftriaxone Villerton
3. How Ceftriaxone Villerton is given
4. Possible side effects
5. How to store Ceftriaxone Villerton
6. Contents of the packaging and other information
What Ceftriaxone Villerton is and what it is used for
Ceftriaxone Villerton is an antibiotic given to adults and children (including newborns). It works by killing bacteria that cause infection. It belongs to a group of medicines called cephalosporins.
Ceftriaxone Villerton is used to treat infections in:
- the brain ( meningitis ).
- the lungs.
- middle ear.
- the abdomen or abdominal wall ( peritonitis ).
- urinary tract and kidneys.
- legs and joints.
- skin or soft tissues.
- the blood.
- the heart.
It can be given:
- to treat certain sexually transmitted diseases ( gonorrhea and syphilis ).
- to treat patients with low white blood cell count ( neutropenia ) who have a fever caused by a bacterial infection.
- to treat your chest infection in adults with chronic bronchitis.
- to treat Lyme disease (caused by tick bites) in adults and children including newborns from 15 days of age.
- to prevent infection during surgery.
Ceftriaxone contained in Ceftriaxone Villerton may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Ceftriaxone Villerton
You should not be treated with Ceftriaxone Villerton if:
- You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
- You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms include sudden swelling of the throat or face which may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, and severe rashes that develop rapidly.
- You are allergic to lidocaine and you should receive Ceftriaxone Villerton as an injection into a muscle.
Ceftriaxone Villerton should not be given to infants if :
- The baby is born prematurely.
- The baby is a newborn (up to 28 days of age) and has certain types of blood problems or jaundice (yellowing of the skin or whites of the eyes) or if the baby is to be given a product that contains calcium in a vein.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before being treated with Ceftriaxone Villerton if:
- You are experiencing or have previously experienced a combination of some of the following symptoms: rash, redness, blisters on the lips, eyes, and mouth, scaly skin, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests, and an increase in a type of white blood cells ( eosinophilia ) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
- you have recently received or will receive products that contain calcium.
- you have recently had diarrhea after taking an antibiotic, or if you have ever had stomach problems, especially colitis ( inflammation of the intestines).
- you have liver or kidney problems.
- you have gallstones or kidney stones.
- you have other diseases, such as hemolytic anemia (a decrease in your red blood cells that can make your skin pale yellow and cause weakness or shortness of breath).
- you are on a sodium controlled diet.
If you need a blood or urine sample
If you are being treated with Ceftriaxone Villerton for a long time, you may need to have regular blood tests. Ceftriaxone Villerton may affect the results of urine sugar tests and a blood test called the Coombs test. If you are going to take a test:
- Tell the person taking the test that you are being treated with Ceftriaxone Villerton.
Talk to your doctor, pharmacist or nurse before treating your child with Ceftriaxone Villerton if:
- he/she has recently received or will receive, a product that contains calcium in a vein.
Other medicines and Ceftriaxone Villerton
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking any of the following medicines, tell your doctor or pharmacist in particular:
- A type of antibiotic called an aminoglycoside.
- An antibiotic called chloramphenicol (used to treat infections, especially in the eyes).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefits of treating you with Ceftriaxone Villerton against the risk to your child.
Driving and using machines
Ceftriaxone Villerton may cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience any of these symptoms.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ceftriaxone Villerton contains sodium
This medicine contains 82.8 mg of sodium (the main ingredient in table salt/table salt) per gram. This corresponds to 4% of the highest recommended daily intake of sodium for adults.
How Ceftriaxone Villerton is given
Ceftriaxone Villerton is usually given by a doctor or nurse. It can be given as a drip ( intravenous infusion ) or as an injection directly into a vein or muscle. Ceftriaxone Villerton is prepared by your doctor, pharmacist or nurse and will not be mixed with or given at the same time as calcium-containing injections.
The usual dose is one
Your doctor will determine the correct dose of Ceftriaxone Villerton for you. Dose one depends on the severity and type of infection, whether you are on any other antibiotics, your weight and age, and how well your kidneys and liver are working. The number of days or weeks you receive Ceftriaxone Villerton depends on the type of infection you have.
Adults, the elderly, and children 12 years or older and weighing 50 kilograms (kg) or more :
- 1 to 2 g once a day depending on the severity and type of infection. If you have a serious infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you can get it as a single dose once a day or as two separate doses .
Newborns and children from 15 days to 12 years of age with a bodyweight of less than 50 kg :
- 50-80 mg Ceftriaxone Villerton for each kg of body weight once daily depending on the severity and type of infection. If you have a serious infection, your doctor will give you a higher dose of up to 100 mg per kg of body weight up to a maximum of 4 g once daily. If your daily dose is higher than 2 g, you can get it as a single dose once a day or as two separate doses .
- Children with a bodyweight of 50 kg or more should be given the usual dose for adults.
Newborns (0-14 days )
- 20-50 mg Ceftriaxone Villerton for each kg of body weight once daily depending on the severity and type of infection.
- The maximum daily dose should not exceed 50 mg per kg of bodyweight of the child.
People with liver and kidney problems
You may be given a different dose than the standard dose. Your doctor will decide how much Ceftriaxone Villerton you need and will monitor you carefully depending on how severe your liver or kidney disease is.
If you take more Ceftriaxone Villerton than you should
If you accidentally get more than the prescribed dose, contact your doctor or nearest hospital immediately.
If you forget to use Ceftriaxone Villerton
If you miss an injection, get it as soon as possible. However, if it is soon time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to compensate for a missed dose.
If you stop using Ceftriaxone Villerton
Do not stop taking Ceftriaxone Villerton unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Severe allergic reactions ( frequency not known, cannot be calculated from the available data)
If you get a severe allergic reaction, tell your doctor immediately.
Symptoms may include:
- Sudden swelling of the face, neck, lips, or mouth. This may make it difficult to breathe or swallow.
- Sudden swelling of hands, feet, or ankles.
Severe skin reactions ( not known frequency, can not be calculated from the available data )
If you get severe skin reactions, tell your doctor immediately.
Symptoms may include:
- Severe skin rash that develops suddenly, with blisters or scaling of the skin and possibly blisters in the mouth (Steven-Johnson syndrome and toxic epidermal necrolysis also known as SJS and TEN).
- A combination of some of the following symptoms: scattered skin rash, high body temperature, elevated liver enzyme levels, abnormal blood levels ( eosinophilia ), enlarged lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or hypersensitivity syndrome).
- Jarisch-Herxheimer reaction causes fever, chills, headache, muscle aches, and a rash which is usually transient. This occurs shortly after treatment with ceftriaxone Are Fullerton sprocket- against infection s such as Lyme disease has begun.
Other possible side effects:
Common ( may affect up to 1 in 10 people)
- Abnormalities in your white blood cells (such as a decrease in leukocytes and an increase in eosinophils ) and platelets (decrease in platelets ).
- Loose stools or diarrhea.
- Changes in the results of blood tests for liver function.
Uncommon ( may affect up to 1 in 100 people )
- Fungal infections (eg cod).
- A decrease in the number of white blood cells ( granulocytopenia ).
- A decrease in the number of red blood cells ( anemia ).
- Problems with blood clotting ability. Symptoms may include bruising and joint pain and swelling.
- Nausea or vomiting.
- Pruritus ( itching ).
- Pain or a burning sensation along the vein in which Ceftriaxone Villerton was given. Pain where the injection was given.
- High body temperature (fever).
- Abnormal kidney function test (increased blood creatinine).
Rare (may affect up to 1 in 1,000 people)
- Inflammation of the colon ( colon ). Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
- Difficulty breathing.
- Elevated rash ( hives ) that can cover large parts of your body, and itchy feeling, and swelling.
- Blood or sugar in the urine.
- Edema (fluid retention).
No known frequency ( cannot be calculated from the available data )
- A secondary infection may not respond to the antibiotic previously prescribed.
- A type of anemia in which red blood cells are destroyed ( hemolytic anemia ).
- Severe decrease in white blood cells ( agranulocytosis ).
- Dizziness (a tingling sensation).
- Inflammation of the pancreas ( pancreatitis ). Symptoms include severe abdominal pain that spreads to your back.
- Inflammation of the mucous membrane of the mouth ( stomatitis ).
- Inflammation of the tongue ( glossitis ). Symptoms include swelling, redness, and soreness of the tongue.
- Problems with the gallbladder, which can cause pain, nausea, and vomiting.
- A neurological condition that can occur in newborns with severe jaundice (kernicterus).
- Kidney problems caused by precipitation of calcium ceftriaxone. Pain may occur when urinating, or urine production may decrease.
- A false-positive result for the Coombs test (a test for certain blood problems).
- A false-positive test for galactosemia (an abnormal accumulation of galactose sugar).
- Ceftriaxone Villerton may interfere with certain types of blood glucose tests – ask your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Ceftriaxone Villerton
Keep out of sight and reach of children.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
The active substance is ceftriaxone 1 g and 2 g respectively (as ceftriaxone disodium hemiheptahydrate).
What the medicine looks like and contents of the pack
Vials of glass of white to off white crystalline powder, 1 g or 2 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Villerton Invest SA
Rue Edward Steichen, 14
ANFARM GREECE, Schimatari Viotia 320 09, Greece
ACS DOBFAR SPA, 64100 Teramo, Italy
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.
Mylan Hospital AS
PO Box 194, 1371 ASKER