Vibativ
telavancin
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What VIBATIV is and what it is used for
What you need to know before you use VIBATIV
How to use VIBATIV
Possible side effects
How to store VIBATIV
Medicinal product no longer authorised
Contents of the pack and other information
VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group. VIBATIV is used to treat adult patients with infections of the lungs that have developed in the hospital, including patients on artificial ventilation, when these infections are known or suspected to be caused by bacteria called methicillin-resistant Staphylococcus aureus (MRSA).
It is only used when the bacteria that cause these infections can be killed with telavancin. VIBATIV
can only be used when other antibiotics are not suitable.
If you also have other bacteria that cause your infection, your doctor may prescribe other antibiotics in addition to VIBATIV.
if you are allergic (hypersensitive) to telavancin or any of the other ingredients of VIBATIV (listed in section 6)
If you suffer from severe kidney problems, or receive haemodialysis
if you are pregnant
Talk to your doctor or nurse before you are given VIBATIV
if you have kidney problems. Your doctor may decide to reduce the dose of VIBATIV and monitor you more closely during treatment. Alternatively, your doctor may decide that this medicine is not suitable for you.
if you are at greater risk of developing kidney disorders or if you are receiving other
medicines that can affect your kidney. Your doctor will tell you if this is the case and may decide to monitor you more closely during treatment.
if you experience skin reactions to the product. Your doctor may decide to adjust the rate of the infusion.
if you are allergic to antibiotics such as vancomycin. Tell your doctor immediately if this is the
case.
if you are suffering from heart disorders. Tell your doctor immediately if this is the case.
if you notice a change in your hearing. Tell your doctor immediately if this is the case. Your doctor may monitor your hearing during treatment. Ringing in the ears and deafness are possible side effects.
While antibiotics including VIBATIV fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for any potential infections and treat you if necessary.
if you develop diarrhoea during or shortly after your treatment, tell your doctor immediately. Do
not take any diarrhoea medicine without first checking with your doctor.
if you are suffering from more than one infection. Your doctor will treat you as necessary.
Telavancin is not to be used in children or adolescents under 18 years of age.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Telavancin may interfere with some laboratory tests that measure how well your blood is clotting. The test results can suggest poor blood clotting when, in fact, there is no problem. Tell your doctor that
Medicinal product no longer authorised
you are receiving VIBATIV.
Telavancin may interfere with some laboratory tests that measure proteins in the urine. Tell your doctor that you are receiving VIBATIV.
Telavancin must not be given to pregnant women. Tell your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant. You have to use effective contraception during treatment with VIBATIV.
It is not known if telavancin passes into breast milk in humans. Ask your doctor for advice before breastfeeding your baby.
VIBATIV may cause side effects, such as dizziness, sleepiness, confusion or blurred vision that can have an influence on the ability to drive or operate machinery.
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
VIBATIV will be given to you by a doctor or a nurse.
The dose given will depend on how much you weigh. The dose for adults (18 years and older) is
10 milligrams (mg) for every kilogram (kg) of body weight, given once a day. This dose is given as an infusion (drip into a vein) over a period of about 60 minutes.
If your kidneys do not work well or if you are overweight, the dose may be reduced.
A course of treatment usually lasts for 7 to 21 days. Your doctor will decide how long you should be treated.
If you are given more VIBATIV than you should receive, the chance of experiencing the following side effects increases: disturbed taste, nausea (feeling sick), vomiting, reactions at the site of the infusion, headache, rash, skin flushing of the upper body. If this happens, the infusion of telavancin will be stopped and the doctor will check the functioning of your kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, VIBATIV can cause side effects, although not everybody gets them. VIBATIV may cause the following side effects:
Very common: may affect more than 1 in 10 people
taste disturbance
nausea (feeling sick)
Common: may affect up to 1 in 10 people
fungal infections
sleeplessness
headache, dizziness
constipation, diarrhoea; vomiting
raised blood levels of liver enzymes
Medicinal product no longer authorised
itching, rash
kidney disorder, abnormal kidney function tests, foamy urine
tiredness, chills
Uncommon: may affect up to 1 in 100 people
intestinal bacterial infection; urinary tract infection
anaemia, changes in white blood cell counts; changes in blood platelet counts
allergic reactions
decreased appetite; changes in blood levels of glucose; changes in blood levels of potassium and magnesium
restlessness; anxiety; confusion; depression
loss of taste, migraine, abnormal touch sensation, smell disturbance, sleepiness, trembling
eye irritation; blurred vision
ringing in your ears
chest pain; heart failure; abnormal heart rhythm or heart beat
flushing; high or low blood pressure; inflammation of a vein
breathlessness, hiccups, nasal congestion, sore throat
abdominal pain; dry mouth; indigestion, bloating; numbness of the mouth
liver inflammation
skin redness; swelling of face; sweating, hives
joint pain; back pain; muscle cramp; muscle pain
painful urination; blood in urine; low urine output, frequent urination; abnormal urine odour
lack of energy; irritation at infusion site; feeling unwell; chest discomfort; accumulation of fluid in the lower legs; pain; fever; skin flushing of upper body
abnormal blood clotting tests
Rare: may affect up to 1 in 1,000 people
deafness
Not known: frequency cannot be estimated from the available data
severe allergic reactions (anaphylaxis). The first signs of a severe allergic reaction may include swelling of the skin, face and/or throat and/or difficulty breathing. If these symptoms occur you must inform your doctor or nurse immediately.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystemlistedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use VIBATIV after the expiry date that is stated on the label and carton after EXP: The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Keep the vial in the outer carton to protect the product from light.
Medicines 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.
Medicinal product no longer authorised
Each vial contains 250 mg or 750 mg telavancin (as hydrochloride). After reconstitution, each ml of concentrated solution contains 15 mg of telavancin.
The other ingredients are hydroxypropylbetadex, mannitol (E421), sodium hydroxide (E524) (for pH adjustment) and hydrochloric acid (E507) (for pH adjustment).
VIBATIV powder for concentrate for solution for infusion is provided as a 30 ml or 50 ml clear glass vial with rubber stopper, with an aluminium closure with plastic flip-off caps. The vial contains a white to pale pink powder.
Pack sizes:
1 vial of 30 ml with 250 mg telavancin
1 vial of 50 ml with 750 mg telavancin
Theravance Biopharma Ireland Limited
Connaught House 1, Burlington Road, Fourth Floor D04 C5Y6
Dublin 4, Ireland
Biotec Services International Limited Biotec House
Central Park, Western Avenue
Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
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The following information is intended for medical or healthcare professionals only:
Method of administration
Medicinal product no longer authorised
VIBATIV must be reconstituted and then further diluted prior to administration by intravenous infusion through a dedicated line or through a Y-site over a 60 minute period. Bolus injections must not be administered.
The following formula can be used to calculate to volume of reconstituted VIBATIV concentrate required to prepare a dose:
Telavancin dose (mg) = 10 mg/kg (or 7.5 mg/kg) x patient body weight (in kg) Volume of reconstituted concentrate (ml) = Telavancin dose (mg)/15 (mg/ml) Incompatibilities
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
Shelf life
Shelflifeofreconstitutedconcentrate: The reconstituted concentrate should be diluted immediately after preparation.
Shelflifeofdilutedproduct: Chemical and physical in use stability of the reconstituted solution and the diluted solution in the infusion bag has been demonstrated for 24 hours under refrigeration
(2-8°C). From a microbiological point of view the product should be used immediately. If not used immediately, in use storage times are the responsibility of the user and should not be longer than 24 hours at 2-8°C.
Special precautions for disposal and other handling
The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Preparation of the reconstituted concentrate (VIBATIV 250 mg vial)
The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml
(0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 17 ml).
Preparation of the reconstituted concentrate (VIBATIV 750 mg vial)
The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 50 ml).
Discard the vial if the vacuum does not pull the diluent into the vial.
Aseptic technique must be used to reconstitute VIBATIV. After addition of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, the contents of the vial are mixed by swirling gently to facilitate reconstitution.
Reconstitution time is not more than 5 minutes for the vial containing 250 mg. Reconstitution time is not more than 10 minutes for the vial containing 750 mg.
Mixing is continued until the content of the vial is completely dissolved and is free of particulate matter by visual inspection.
Appearance of reconstituted concentrate
A reconstituted concentrate of VIBATIV is a clear, colourless to pale pink solution. Foaming may occur during reconstitution but will dissipate upon standing.
Preparation of final diluted solution for infusion
Medicinal product no longer authorised
Reconstituted concentrate must be further diluted prior to administration.
For doses of 150 to 800 mg, the appropriate volume of reconstituted concentrate must be further diluted in 100 to 250 ml prior to infusion. Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final solution of 0.6 to 8 mg/ml. Appropriate infusion solutions include: dextrose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or lactated Ringer’s solution for injection. The dilution is to be made under aseptic conditions.
The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.
Disposal
For single use only. Discard any unused solution.
Any unused product or waste material should be disposed of in accordance with local requirements.