glycopeptides
What Vancomycin Orion is and what it is used for
Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by killing certain bacteria that cause your infection.
Vancomycin powder is made into an infusion solution.
Vancomycin is used in all age groups as an infusion to treat the following serious infections:
- Infection in the skin and tissue under the skin.
- Infection in bones and joints.
- Pneumonia.
- Infection of the inside of the heart ( endocarditis ) and to prevent endocarditis in patients at risk of endocarditis when undergoing major surgery.
- Central nervous system infection.
- Infection in the blood is linked to the infections listed above.
The vancomycin contained in Vancomycin Orion may also be approved to treat 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 use Vancomycin Orion
Do not use Vancomycin Orion
- if you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Serious side effects that may lead to loss of vision have been reported following the injection of vancomycin into the eyes.
Talk to your doctor, pharmacist, or nurse before using Vancomycin Orion if:
- You have signs of increasing skin rash, often with blisters or damage to the mucous membranes (Stevens-Johnson syndrome). Contact your doctor. Treatment with vancomycin should be stopped immediately.
- You have ever had a severe skin rash or scaly skin, blisters, and/or sores in your mouth after taking vancomycin? Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using vancomycin and contact your doctor immediately if you notice any of the symptoms described in section 4.
- You have kidney disease (you will need to provide blood and kidney samples during treatment).
- You have a hearing impairment, especially if you are elderly (you may need hearing tests during treatment).
- You also use medicines that can damage the ears (e.g. aminoglycosides, a certain type of antibiotic ).
- You have previously suffered from an allergic reaction to teicoplanin, as this may mean that you are also allergic to vancomycin.
- You receive vancomycin by infusion to treat diarrhea associated with Clostridium difficile infection instead of by mouth.
Talk to your doctor, pharmacist, or nurse during treatment with Vancomycin Orion if:
- You receive vancomycin for a long time (you may need to provide blood, liver, and kidney samples during treatment).
- You get a skin reaction during the treatment.
- If you get severe or prolonged diarrhea during or after using vancomycin; contact a doctor immediately. This can be a sign of intestinal inflammation (pseudomembranous colitis ) which can occur after treatment with antibiotics. Do not take any anti-diarrhea medicine without consulting a doctor first.
Children
Vancomycin should be used with particular caution in premature infants and newborns, as their kidneys are not fully developed and they may accumulate vancomycin in the blood. This age group may need to provide blood samples to check the vancomycin levels in the blood.
Concomitant use of vancomycin and anesthetics (numbing agents) has been associated with skin flushing ( erythema ) and allergic reactions in children.
Other medicines and Vancomycin Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Medicines that can damage the kidneys (eg aminoglycoside antibiotics, piperacillin/tazobactam, iodine contrast agents, non-steroidal anti-inflammatory drugs ( NSAIDs, eg ibuprofen ) or amphotericin B (antifungal medicine), platinum-based chemotherapy (cancer medicine), methotrexate at high doses, and certain medicines against viral infections such as pentamidine, foscarnet, aciclovir, ganciclovir, famciclovir, valaciclovir, valganciclovir, ciclosporin or tacrolimus). If these medicines are given at the same time as vancomycin, the risk of kidney damage may increase and therefore it may be necessary to take blood tests and check kidney function more often.
- Medicines that can damage hearing (eg aminoglycosides, platinum-based chemotherapy, and some diuretics). If these drugs are given at the same time as vancomycin, the harmful effect on hearing may be increased. In such cases, a careful and regular check of the hearing function is necessary.
- Anesthetics: The use of anesthetics increases the risk of certain side effects of vancomycin such as blood pressure drop, skin redness, hives, impaired heart function, and itching.
- Muscle relaxants (eg succinylcholine). If these drugs are given at the same time as vancomycin, the effect of the muscle relaxant may be enhanced or prolonged.
- Medicines that prevent the blood from clotting (eg warfarin ). If these drugs are given at the same time as vancomycin, the effect of warfarin may be increased.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, your doctor should only give you vancomycin if necessary after carefully weighing the benefits and risks. Vancomycin can affect the ears and kidneys of the fetus.
Breast-feeding
Vancomycin passes into breast milk and may affect the baby. Your doctor should only give you vancomycin if necessary and after carefully weighing the benefits and risks. If you receive vancomycin, you should stop breastfeeding.
Driving ability and use of machinery
Vancomycin Orion has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Vancomycin Orion
Administration
You will be given Vancomycin Orion by healthcare professionals while you are in the hospital. Your doctor will decide how much of this medicine you should receive each day and how long the treatment should last.
Dosage
The dose given to you depends on:
- your age,
- your weight,
- what infection you have,
- how well your kidneys are working,
- your hearing,
- other medicines you take.
Intravenous use
Adults and adolescents (from 12 years and older)
Will one be calculated based on your body weight? The usual infusion dose is 15 to 20 mg per kg of body weight. It is usually given every 8 to 12 hours. In some cases, the doctor may decide to give an initial dose of up to 30 mg per kg of body weight. The maximum daily dose should not exceed 2 g.
Use in children
Children from the age of one month to less than 12 years
Will one be calculated based on your child’s body weight? The usual infusion dose is 10 to 15 mg per kg of body weight. It is usually given every 6 hours.
Premature and full-term infants (from 0 to 27 days)
Will one be calculated based on postmenstrual age (the time between the first day of the last menstrual period and delivery (gestational age) plus the time elapsed after birth ( postnatal age))?
Elderly people, pregnant women, and patients with kidney disease, including those receiving dialysis, may need a different dose.
Mode of administration
Intravenous infusion means that the medicine flows from an infusion bottle or bag through a tube into one of your blood vessels and your body. The doctor or nurse will always give vancomycin into the blood and not into a muscle.
Vancomycin is given into a vein over at least 60 minutes.
If someone forgets to give you Vancomycin Orion
A double dose should not be given to compensate for a missed dose. A missed dose should only be given if there is enough time left until the next regular dose.
If treatment with Vancomycin Orion is interrupted or stopped prematurely
Too low a dosage, irregular administration, or premature discontinuation of the treatment can affect the results of the treatment or lead to relapse, which is more difficult to treat. Follow the doctor’s instructions.
If you have received too much Vancomycin Orion
If you have taken too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Vancomycin Orion can cause side effects, although not everybody gets them.
Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock ) are rare. Contact a doctor immediately if you suddenly experience wheezing, difficulty breathing, redness of the upper body, skin rash, or itching.
Stop using vancomycin and contact your doctor immediately if you notice any of the following symptoms:
- Red, non-raised, target-like, or round spots on the trunk, often with blisters in the center, scaly skin, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome and toxic epidermal necrolysis ).
- Widespread rash, fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
- Red, widespread, and scaly rash with nodules under the skin and blisters along with fever that occurs at the beginning of treatment ( Acute generalized exanthematous pustulosis ).
Common side effects (may affect up to 1 in 10 users):
- Drop in blood pressure
- Shortness of breath, noisy breathing (a raspy sound that occurs due to obstructed airflow in the upper airways)
- Rash and inflammation of the mucous membrane of the mouth, itching, itchy rash, hives
- Kidney problems that can be seen mainly through blood tests
- Redness on the upper body and face, inflammation of a vein
Uncommon side effects (may affect up to 1 in 100 users):
- Temporary or permanent hearing loss
Rare side effects (may affect up to 1 in 1,000 users):
- Decrease in white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting)
- Increase in certain white blood cells in the blood
- Loss of balance, ringing in the ears, dizziness
- Vascular inflammation
- Nausea
- Inflammation of the kidneys and kidney failure
- Fever, chills
- Pain in chest and back muscles
Very rare side effects (may affect up to 1 in 10,000 users):
- Sudden onset severe allergic skin reaction with peeling skin, blisters, or peeling. This may be associated with high fever and joint pain
- Inflammation of the intestine causes abdominal pain and diarrhea, which may contain blood
- Cardiac arrest
Frequency not known (frequency cannot be estimated from available data):
- Rash with blisters and fever
- Vomiting, diarrhea
- Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine
- Rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (swollen lymph nodes ), abnormal blood, and liver function tests.
How to store Vancomycin Orion
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C. Store the vial in the outer packaging. Light sensitive.
Instructions for storage after preparation and dilution are given at the end of this leaflet.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment
Contents of the packaging and other information
Contents declaration
The active substance is vancomycin hydrochloride.
1 vial of Vancomycin Orion 500 mg powder for concentrate for infusion solution, solution,
contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin).
1 vial of Vancomycin Orion 1000 mg powder to concentrate for infusion solution, solution, contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin).
This medicine does not contain any other ingredients.
Appearance and package sizes of the medicine
This medicine is a homogeneous, white to light brown freeze-dried powder concentrated into an infusion liquid, solution.
Vancomycin Orion is supplied in colorless glass vials closed with a chlorobutyl rubber stopper and sealed with an aluminum plastic flip cap.
Package sizes
Vancomycin Orion 500 mg powder for concentrate for infusion, solution: powder in 10 ml glass bottle, cartons with 1 or 10 vials.
Vancomycin Orion 1,000 mg powder for concentrate for infusion, solution: powder in 20 ml glass bottle, cartons with 1 or 10 injection bottles.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing Authorisation Holder
Orion Corporation
Orion Indie 1
02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Indie 1
02200 Espoo
Finland