Vantobra

Helstu upplýsingar

  • Heiti vöru:
  • Vantobra
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Vantobra
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Nebuliser solution
  • Lækningarsvæði:
  • Cystic Fibrosis, Respiratory Tract Infections
  • Ábendingar:
  • Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Vörulýsing:
  • Revision: 3

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Withdrawn
  • Leyfisnúmer:
  • EMEA/H/C/002633
  • Leyfisdagur:
  • 17-03-2015
  • EMEA númer:
  • EMEA/H/C/002633
  • Síðasta uppfærsla:
  • 25-05-2019

Opinber matsskýrsla

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An agency of the European Union

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+44 (0)20 3660 6000

Facsimile

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/169512/2015

EMEA/H/C/002633

EPAR summary for the public

Vantobra

tobramycin

This is a summary of the European public assessment report (EPAR) for Vantobra. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Vantobra.

For practical information about using Vantobra, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Vantobra and what is it used for?

Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria

Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis. Cystic fibrosis is

an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria

to grow more easily causing infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis

patients.

Before using Vantobra, doctors should consider official guidance on the appropriate use of antibiotics.

Vantobra is a ‘hybrid medicine’. It contains the active substance tobramycin, which is the same active

substance as that of the reference medicine, Tobi. Both medicines are available as a nebuliser solution.

However, Vantobra differs from Tobi by having a higher concentration of the active substance and is

inhaled using a different type of nebuliser.

How is Vantobra used?

Vantobra is available as a nebuliser solution in single-dose containers called ‘ampoules’. It can only be

obtained with a prescription.

Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule

into a fine mist. The medicine is not to be inhaled with any other device.

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Vantobra

EMA/169512/2015

Page 2/3

The recommended dose is one ampoule twice a day, ideally 12 hours apart. After 28 days of

treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.

Treatment cycles may be repeated for as long as the doctor considers the patient to be benefiting from

If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that

Vantobra is used last.

How does Vantobra work?

The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as

‘aminoglycosides’. It works by disrupting the production of proteins that P. aeruginosa needs to build

its cell walls, resulting in damage to the bacteria, which eventually kills them.

What benefits of Vantobra have been shown in studies?

Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic

fibrosis and the applicant submitted data from the literature to support the use of Vantobra.

In addition, the applicant conducted a ‘bioequivalence’ study in 58 patients with cystic fibrosis aged 6

years and above to determine whether Vantobra produces similar levels of the active substance in the

body as the reference medicine, Tobi. The results of the study showed that Vantobra can be considered

comparable to Tobi.

What are the risks associated with Vantobra?

Side effects with Vantobra are not common. However, the following side effects are seen between 1

and 10 patients in 1,000: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore

throat) and cough. For the full list of all side effects and restrictions, see the package leaflet.

Why is Vantobra approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vantobra’s

benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP

noted that inhaled tobramycin was the ‘gold standard’ for treating P. aeruginosa infection in patients

with cystic fibrosis and that some patients cannot use the dry powder form because they cannot

tolerate it. For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a

useful alternative.

In addition, the time it takes to inhale Vantobra is shorter than for other tobramycin nebulisers and

comparable to the time taken to inhale the dry powder. Vantobra therefore offers the advantage of

better convenience and a higher likelihood of patients keeping to their treatment.

As regards safety, the Committee noted that safety profile of inhaled tobramycin was well known.

There were no unusual safety findings with Vantobra.

What measures are being taken to ensure the safe and effective use of

Vantobra?

A risk management plan has been developed to ensure that Vantobra is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

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Vantobra

EMA/169512/2015

Page 3/3

the package leaflet for Vantobra, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan

Other information about Vantobra

The European Commission granted a marketing authorisation valid throughout the European Union for

Vantobra on 18 March 2015.

The full EPAR and risk management plan summary for Vantobra can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

information about treatment with Vantobra, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 03-2015.

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Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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Package leaflet: Information for the patient

Vantobra 170 mg nebuliser solution

Tobramycin

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. See section 4.

What is in this leaflet

What Vantobra is and what it is used for

What you need to know before you use Vantobra

How to use Vantobra

Possible side effects

How to store Vantobra

Contents of the pack and other information

1.

What Vantobra is and what it is used for

What Vantobra is

Vantobra contains an antibiotic medicine called tobramycin. It belongs to a class of antibiotic medicines

called aminoglycosides.

What Vantobra is used for

Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by

bacteria named

Pseudomonas aeruginosa

Pseudomonas aeruginosa

is a bacterium that frequently infects the lungs of cystic fibrosis patients at some

time during their lives. If the infection is not properly treated, it continues to damage the lungs, causing

further problems with breathing.

How Vantobra works

When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the

infection. It works by disrupting the production of proteins that the bacteria need to build their cell walls.

This damages the bacteria and eventually kills them.

2.

What you need to know before you use Vantobra

Do not use Vantobra:

if you are allergic (hypersensitive) to tobramycin, to any type of aminoglycoside antibiotics, or to any

of the other ingredients of Vantobra (listed in section 6).

If this applies to you, tell your doctor before using Vantobra.

Warnings and precautions

Talk to your doctor if you have ever had any of the following conditions:

hearing problems (including noises in your ears and dizziness);

kidney problems;

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chest tightness;

blood in your sputum (the substance you cough up);

muscle weakness that lasts or becomes worse over time, a symptom mostly related to conditions such

as myasthenia (muscle weakness) or Parkinson’s disease.

If any of these apply to you, tell your doctor before using Vantobra.

If you have problems with your hearing or kidney function, your doctor may take blood samples to monitor

the amount of Vantobra in your system.

Inhaling medicines can cause chest tightness due to narrowing of the airways, and this can happen with

Vantobra. Your doctor may ask you to use other appropriate medicines to widen the airways before using

Vantobra.

Strains of

Pseudomonas

can become resistant to treatment with an antibiotic over time. This means that

Vantobra may not work as well as it should over time. Talk to your doctor if you are concerned about this.

If you are also taking tobramycin or another aminoglycoside antibiotic by injection, it may increase the risk

of side effects and your doctor will monitor for these as appropriate.

Children

The medicine is not intended for use in children under 6 years of age.

Other medicines and Vantobra

Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

You should not take the following medicines while you are using Vantobra:

furosemide, a diuretic (“water tablet”);

other medicines with diuretic potential such as urea or mannitol;

other medicines which may harm your kidneys or hearing:

amphotericin

cefalotin,

polymyxins

(used

treat

microbial

infections),

ciclosporin,

tacrolimus (used to reduce the activity of immune system). These medicines may harm the

kidneys;

platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).

These medicines may harm the kidneys or hearing.

The following medicines can increase the risks of harmful effects occurring if they are given to you while

you also take tobramycin or another aminoglycoside antibiotic given by injection:

anticholinesterases

such

neostigmine

pyridostigmine

(used

treat

muscle

weakness),

botulinum toxin. These medicines may cause muscle weakness to appear or become worse.

If you are taking one or more of the above medicines, talk to your doctor before you use Vantobra.

You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is

provided together with Vantobra.

If you are taking several different treatments for cystic fibrosis, you should take them in the following order:

Bronchodilator therapy, such as salbutamol

Chest physiotherapy

Other inhaled medicines

Vantobra

Please check this order with your doctor as well.

Pregnancy and breast-feeding

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 using this medicine.

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It is not known whether inhaling this medicine while you are pregnant causes side effects. When they are

given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such

as deafness and kidney problems.

If you are breast feeding, you should talk to your doctor before using this medicine.

Driving and using machines

Vantobra is not expected to affect your ability to drive or use machines.

3.

How to use

Vantobra

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is two ampoules each day (one in the morning and one in the evening) for 28 days.

The dose is the same for all persons aged 6 years and older.

Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using

the Tolero

nebuliser handset.

It is best to have an interval as close as possible to 12 hours between doses, but this interval must be at

least 6 hours.

After you have used your medicine for 28 days, you then have a 28-day break, during which you do not

inhale any Vantobra. You then start another course after the break (as illustrated).

It is important that you keep using the medicine twice each day during your 28 days on treatment, and

that you keep to the 28-day on / 28-day off cycle.

ON Vantobra

OFF Vantobra

Use Vantobra twice a day for 28 days

Do not use any Vantobra for the next 28 days

Repeat cycle

Continue using Vantobra on this cyclical basis for as long as your doctor tells you.

If you have questions about how long to use Vantobra, talk to your doctor or pharmacist.

Preparing Vantobra for inhalation

Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you

inhale the correct dose. Do not use the Tolero nebuliser handset for any other medicine

.

Read the Instructions for Use provided with the handset device before use.

Make sure you have an eFlow

rapid

or eBase controller to connect the Tolero nebuliser handset. The

respective controller can be prescribed by your physician or purchased separately.

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Wash your hands thoroughly with soap and water.

Remove one ampoule of Vantobra from the aluminium foil pouch just before inhalation.

Keep the rest of the medicine refrigerated in the original carton.

Lay out all the pieces of your Tolero nebuliser handset on a clean, dry paper or cloth towel. Make

sure the nebuliser handset is on a flat, stable surface.

Assemble the Tolero nebuliser handset as illustrated in the Instructions for Use of the handset device.

Hold the ampoule upright and tap lightly before twisting off the head part to avoid spilling. Empty

the contents of one ampoule into the medication reservoir of the nebuliser handset.

Begin your treatment sitting in an upright position, in a well ventilated room. Hold the nebuliser

handset horizontally and breath normally through your mouth. Avoid breathing through your nose.

Continue to inhale and exhale comfortably until the treatment is finished. When all of the medicine

has been delivered, you will hear the “treatment complete” tone.

If you need to interrupt your treatment for any reason, press and hold the On/Off button for one full

second. To re-start the treatment, press and hold the On/Off button again for one full second to

resume treatment.

The Tolero nebuliser handset must be cleaned and disinfected as described in the instructions for use

of the device.

Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with

the medicine.

Do not use an alternative untested nebuliser system because it may alter the amount of medicine reaching the

lungs. This in turn may alter how well the medicine works and its safety.

If you use more Vantobra than you should

If you inhale too much Vantobra you may get a very hoarse voice. Tell your doctor as soon as possible. If

Vantobra is swallowed, it is unlikely to cause severe problems as tobramycin is poorly absorbed from the

stomach, but you should still tell your doctor as soon as possible.

If you forget to use Vantobra

If you forget to use Vantobra and there are at least 6 hours to your next dose, use your dose as soon as you

can. Otherwise, wait for your next dose. Do not use a double dose to make up for a forgotten dose.

If you stop using

Vantobra

Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be

controlled sufficiently and may become worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

chest tightness with difficulty in breathing (rare, affecting up to 1 in 1,000 people)

allergic reactions including hives and itching (very rare, affecting up to 1 in 10,000 people).

If you experience any of these, stop using Vantobra and tell your doctor straight away.

People with cystic fibrosis have many symptoms of the disease. These may still occur while using Vantobra,

but should not be as frequent or worse than before.

If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor

straight away.

Medicinal product no longer authorised

Other side effects may include:

Uncommon (may affect up to 1 in 100 people)

shortness of breath

voice alteration (hoarseness)

increased cough

sore throat

Rare (may affect up to 1 in 1,000 people)

laryngitis (inflammation of the voice box that can cause voice alteration, sore throat and difficulty

swallowing)

Loss of voice

headache, weakness

nosebleed, runny nose

ringing in the ears (normally transient), hearing loss, dizziness

coughing up blood, producing more sputum than normally, chest discomfort, asthma, fever

taste disturbances, feeling sick (nausea), mouth ulcers, being sick (vomiting), loss of appetite

rash

chest pain or general pain

worsening of lung function test results

Very rare (may affect up to 1 in 10,000 people)

fungal infections of the mouth or throat, such as thrush

swelling of lymph glands

sleepiness

ear pain, ear problems

hyperventilating, low oxygen levels in your blood, sinusitis

diarrhoea, pain in and around the stomach

red pustules, papules on the skin

nettle rush, itching

back pain

generally feeling unwell

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix

V. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Vantobra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the ampoule or the pouch or carton after

EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). If you don’t have a refrigerator available (such as when you are

transporting your medicine) you can store the carton with the medicine (pouches opened or unopened)

below 25°C for up to 4 weeks. If the product has been stored at room temperature for longer than 4

weeks, it has to be disposed according to local requirements.

Do not use this medicine if you notice that it has become cloudy, or if there are particles in the solution.

Never store an opened ampoule. Once opened an ampoule should be used immediately, and any

remaining product should be discarded.

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Do not throw away any medicines via household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Vantobra contains

The active substance is tobramycin. One ampoule contains 170 mg of tobramycin as a single dose.

The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate,

water for injections, sulphuric acid and sodium hydroxide for pH adjustment.

What Vantobra looks like and contents of the pack

Vantobra nebuliser solution is provided in a ready-to-use ampoule.

Vantobra is a clear to slightly yellow coloured solution which can vary to a darker yellow. This does not

change how Vantobra works provided that the storage instructions have been followed.

Ampoules are packed in pouches, one pouch contains 8 ampoules which correspond with 4 days of

treatment.

Vantobra is available together with a Tolero nebuliser handset. It is supplied in a carton that contains two

inner cartons, one with the medicine (56 ampoules with nebuliser solution

in 7 pouches), and one with the

nebuliser handset. A package is sufficient for one treatment cycle of 28 days.

Marketing Authorisation Holder and Manufacturer

PARI Pharma GmbH

Moosstrasse 3

D-82319 Starnberg

Germany

Tel.:

+49 (0) 89 – 74 28 46 - 10

Fax:

+49 (0) 89 – 74 28 46 30

E-Mail: info@paripharma.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

Medicinal product no longer authorised