10 micrograms/ml Solution for nebulizer
Iloprost
What Ventavis is and what it is used for
What Ventavis is
The active substance in Ventavis is iloprost. It mimics a natural substance in the blood called prostacyclin. Ventavis prevents blood vessels from becoming blocked or constricted, and thus increases blood flow through vessels.
What Ventavis is used for
Ventavis is used to treat moderately severe cases of primary pulmonary hypertension (PPH) in adult patients. PPH is a category of pulmonary hypertension where the cause of high blood pressure is unknown. It is a condition where blood pressure is too high in the blood vessels between the heart and the lungs. Ventavis is used to improve physical performance (ability to perform physical activity) and symptoms.
How Ventavis works
When you inhale the mist, Ventavis is carried down into the lungs, where it can very effectively affect the artery between the heart and the lungs.
Improved blood flow leads to better oxygen supply in the body and reduced strain on the heart.
What you need to know before using Ventavis
Do not use Ventavis
- if you are allergic to iloprost or any of the other ingredients of this medicine (listed in section 6),
- if you have an increased risk of bleeding – for example, if you have an active ulcer in the stomach or the upper part of the small intestine (duodenal ulcer ), if you have suffered a physical injury (trauma), if there is a risk of bleeding in the cranium (skull),
- if you have heart problems, such as
- poor blood flow to the heart muscle (severe coronary artery disease or unstable angina). Symptoms may include chest pain.
- a heart attack in the last six months,
- a weak heart (decompensated heart failure ) that is not closely monitored by doctors
- severely unstable heartbeats,
- a heart valve defect (congenital or acquired) that causes the heart to function poorly (not related to pulmonary hypertension ),
- if you have suffered a stroke in the last 3 months, or any other event that reduced blood flow to the brain (e.g. transient ischemic attack),
- if your pulmonary hypertension is due to a blocked or narrowed vein (venous occlusive disease).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ventavis:
- Inhalation of Ventavis may cause breathing difficulties (see section 4), especially in patients with bronchospasm (sudden contraction of the muscles in the walls of the smaller airways) and wheezing. Tell your doctor if you have a lung infection, severe asthma, or chronic lung disease ( chronic obstructive pulmonary disease ). Your doctor will monitor you closely.
- Your blood pressure is checked before treatment and if it is too low (below 85 mm Hg as the upper value) treatment with Ventavis should not be started.
- In general, you need to be especially careful to try to avoid the effects of low blood pressure, such as fainting and dizziness:
- Tell your doctor if you are taking other medicines as the combination with Ventavis can further lower your blood pressure (see under “Other medicines and Ventavis”).
- Get up slowly from a sitting or lying position.
- If you tend to pass out as soon as you get out of bed, it may help if you take your first dose while still lying down.
- If you are prone to fainting, avoid excessive exertion, e.g. during physical exercise; it may help to inhale Ventavis before.
- Fainting attacks may be due to the underlying disease.
- Tell your doctor if it gets worse. Your doctor may consider adjusting your dose or changing your treatment.
- If you suffer from a weak heart condition such as right-sided heart failure and feel that your condition is getting worse, tell your doctor. Symptoms may include swollen feet and ankles, shortness of breath, palpitations, more frequent urination during the night, or edema. Your doctor will consider whether your treatment needs to be changed.
- If you experience difficulty breathing, cough up blood and/or sweat profusely, this may be a sign of fluid accumulation in the lungs ( pulmonary edema). Stop using Ventavis and talk to your doctor straight away. He/she will investigate the cause and take appropriate action.
- If you have liver problems or very severe kidney problems that require dialysis, contact your doctor. You may be given a gradually higher dose, or prescribed a lower dose of Ventavis than other patients (see section 3 “How to use Ventavis”).
Skin contact with Ventavis or swallowing Ventavis
- DO NOT allow Ventavi solution to come into contact with your skin or eyes. If it does, flush skin or eyes immediately with plenty of water.
- DO NOT drink or swallow Ventavis solution. If you accidentally swallow Ventavis, drink plenty of water and contact your doctor.
Children and young people
The safety and effectiveness of Ventavis given to children under 18 years of age have not been established.
Other medicines and Ventavis
Tell your doctor or pharmacist if you have recently used, or might be using other medicines.
Ventavis and some other medicines can affect each other’s way of working in the body.
Tell your doctor if you use:
- Medicines used in the treatment of high blood pressure or heart disease such as
- beta-blockers
- nitroglycerin- type vasodilators,
- ACE inhibitors.
Your blood pressure may drop much more.
Your doctor may change your dosage.
- Medicines that thin the blood or inhibit blood coagulation, incl
- acetylsalicylic acid (ASA – a substance in many medicines that lowers fever and relieves pain),
- heparin,
- coumarin-type anticoagulants, such as warfarin or phenprocoumon,
- non-steroidal anti-inflammatory drugs,
- non-selective phosphodiesterase inhibitors such as pentoxifylline,
- selective phosphodiesterase 3 (PDE 3) inhibitors, such as cilostazol or anagrelide,
- ticlopidine,
- clopidogrel,
- glycoprotein IIb/IIIa inhibitors such as
- abciximab,
- eptifibatide,
- tirofiban,
- defibrotide.
Your doctor will monitor you closely.
Before taking any medicine, talk to your doctor or pharmacist who has more information about medicines you should be careful with or avoid while using Ventavis.
Ventavis with food and drink
Food and drink are not expected to affect Ventavis. You should still avoid eating and drinking while inhaling.
Pregnancy
- If you suffer from pulmonary hypertension, avoid becoming pregnant as pregnancy can cause a worsening of your condition and even become life-threatening.
- If you can become pregnant, use reliable contraception from the start of treatment and throughout treatment.
- If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor immediately. Ventavis should only be used during pregnancy if your doctor considers that the potential benefits outweigh the potential risks to you and the fetus.
Breast-feeding
It is unknown whether Ventavis is excreted in breast milk. A possible risk for the breastfed child cannot be excluded and breastfeeding should therefore be avoided during treatment with Ventavis.
Ask your doctor or pharmacist for advice before taking any medicine.
Newborns, infants, and pregnant women should not be in the room while inhaling Ventavis.
Driving ability and use of machinery
Ventavis lowers blood pressure and can cause dizziness or a feeling of intoxication in some people. Do not drive or use tools or machines if you feel these effects.
Ventavis contains ethanol
Ventavis 10 micrograms/ml contains 0.81 mg of alcohol ( ethanol ) per ml corresponding to 0.081% w/v. The amount of 0.81 mg of alcohol in 1 ml of this medicine is equivalent to less than 1 ml of beer or wine.
The low amount of alcohol in this medicine does not produce any noticeable effects.
How to use Ventavis
Treatment with Ventavis should only be started by a doctor experienced in the treatment of pulmonary hypertension.
How much should you inhale and for how long?
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
The dose and length of treatment that is right for you depends on your condition. Your doctor will help you. Do not change the recommended dose without first consulting your doctor.
Different nebulizers can be used to administer Ventavis. Depending on the type of nebulizer used and the dose prescribed, 1 ml or 2 ml of Ventavis 10 micrograms/ml is suitable.
- Breelib nebulizer
If you start treatment or if you switch from an alternative nebulizer, your first inhalation will be with Ventavis 10 micrograms/ml (1 ml ampoule with white and yellow rings). If you tolerate this dose well, your next inhalation will be with Ventavis 20 micrograms/ml ( ampoule with yellow and red rings). You should continue with this dose.
If you do not tolerate inhalation with Ventavis 20 micrograms/ml, you should talk to your doctor who can decide that you should take Ventavis 10 micrograms/ml (1 ml ampoule ).
Most people need 6-9 inhalation sessions spread over the day. Each inhalation session with Breelib usually lasts about 3 minutes.
Your doctor will monitor your treatment when you start using the Breelib nebulizer to make sure you tolerate the dose and the rate of inhalation.
- I-Neb AAD nebulizer (1 ml ampoule with white and yellow rings)
Usually, the first inhaled dose when you start treatment with Ventavis should be 2.5 micrograms of iloprost given through the mouthpiece. If you tolerate dose one well, your dose should be increased to 5 micrograms of iloprost and you should maintain that dose one. If a 5-microgram dose is poorly tolerated, dose one should be reduced to 2.5 micrograms.
Most people need 6-9 inhalation sessions spread over the day. Each inhalation session with I‑Neb AAD usually lasts approximately 4‑10 minutes, depending on the prescribed dose.
- Venta-Neb nebulizer (2 ml ampoule with white and pink rings)
Usually, the first inhaled dose when you start Ventavis treatment should be 2.5 micrograms of iloprost given through the mouthpiece. If you tolerate dose one well, your dose should be increased to 5 micrograms and you should maintain that dose one. If a 5-microgram dose is poorly tolerated, dose one should be reduced to 2.5 micrograms.
Most people need 6-9 inhalation sessions spread over the day. Each inhalation session with Veta‑Neb usually lasts approximately 4‑10 minutes, depending on the prescribed dose.
Depending on your individual needs, Ventavis can be used for long-term treatment.
If you have kidney or liver problems
It is not necessary to change the dose for patients with mild to moderate renal impairment (patients with a creatinine clearance > 30 ml/min).
If you have very severe kidney problems that require dialysis or if you have liver problems, your doctor will let you start Ventavis gradually and may prescribe fewer inhalations per day. Start treatment by inhaling 2.5 micrograms of iloprost using the 1 ml ampoule (with white and yellow rings) of Ventavis 10 micrograms/ml. Use dosing intervals of 3-4 hours (this corresponds to a maximum of 6 administrations per day). After that, your doctor can carefully shorten the dosing intervals depending on how you tolerate the treatment. If your doctor decides to increase the doseone to 5 micrograms, dosing intervals of 3-4 hours should initially be used again and shortened depending on how you tolerate the treatment.
If you feel that the effect of Ventavis is too strong or too weak, talk to your doctor or pharmacist.
Ask your doctor for someone to help you get used to using the nebulizer properly. You should not change the nebulizer without consulting the doctor treating you.
How you inhale
Use a new Ventavis ampoule for each inhalation. Just before you start inhaling, break the glass ampoule and pour the solution into the medicine container and follow the instructions for use of the nebulizer.
Carefully follow the instructions that come with the nebulizer, especially the instructions on hygiene and cleaning the nebulizer.
Always take Ventavis as directed by your doctor.
- Ventavis 10 micrograms/ml nebulizer solution is intended to be inhaled using the nebulizers prescribed by your doctor (either the Breelib, Venta-Neb, or I‑Neb AAD system).
- The nebulizer converts the Ventavis solution into a mist, which you inhale through your mouth.
- When inhaling, use a mouthpiece to avoid Ventavis coming into contact with your skin. Do not use a face mask.
- Carefully follow any instructions that come with the nebulizer. Ask your doctor or pharmacist if you are unsure.
- Any Ventavis solution left in the nebulizer after inhalation must be thrown away (see section 5).
Room ventilation
Make sure you properly ventilate or ventilate the room where you have taken Ventavis. Other people could accidentally ingest Ventavis with the room air. In particular, newborns, infants, and pregnant women must not be in the room while you inhale Ventavis.
- Breelib
Fill the medicine container with Ventavis immediately before use. Follow the instructions for use for the nebulizer when filling.
| Nebulizer | Drug | Dose of iloprost in the mouthpiece | Approximate inhalation time |
| Breelib | Ventavis 10 micrograms/ml(1 ml ampoule with white and yellow rings) | 2.5 micrograms | 3 minutes |
- I-Neb AAD
- Just before you start inhaling, break the glass ampoule containing 1 ml of solution that has two colored rings (white-yellow), and pour the entire contents into the nebulizer medicine container.
- The preset dose delivered by the I‑Neb AAD is controlled by the drug reservoir in combination with the nebulizer control dial. There are two drug containers with different color codes. For each of the drug containers there is a control disc with the corresponding color code:
- For a dose of 2.5 micrograms, the medication container with the red stopper is used together with the red control disc.
- For a dose of 5 micrograms, the medicine container with the purple stopper is used together with the purple control disc.
- To make sure you get the right dose, check the color of the medicine container and the color of the control dial. They should both be the same color, either red for the 2.5 microgram dose one or purple for the 5 microgram dose one.
| Nebulizer | Dose of iloprost in the mouthpiece | Approximate inhalation time |
| I‑Neb AAD | 2.5 micrograms 5 micrograms | 3.2 min 6.5 min |
The table below contains a summary of the instructions for use for I-Neb:
| Drug | Ampoule/colored ring | Dose | I‑Neb AAD | |
| Medicine container latch | Steering wheel | |||
| Ventavis 10 micrograms/ml | 1 ml ampoulewhite-yellow ring | 2.5 micrograms | RED | RED |
| 5 micrograms | purple | purple |
- Venta-Neb
- Just before you start inhaling, break the glass ampoule containing 2 ml of solution, which has two colored rings (white-pink), and pour the entire contents into the nebulizer’s medicine container.
- Two programs can be used:
- Your doctor will set Venta‑Neb to the program that you need to receive the dose that you have been prescribed.P1 program 1: 5 micrograms of the active ingredient in the mouthpiece 25 inhalation cycles.P2 program 2: 2.5 micrograms of the active ingredient in the mouthpiece 10 inhalation cycles
- You should use the green septum to obtain the droplet size that is optimal for administering Ventavis.
| Nebulizer | Dose of iloprost in the mouthpiece | Approximate inhalation time |
| Venta‑Neb | 2.5 micrograms5 micrograms | 4 min8 min |
For a more detailed description, see the instructions for use for Venta-Neb or ask your doctor.
If you have used too much Ventavis
If you use too much Ventavis, it can lead to dizziness, headache, flushing (flushing), nausea, and pain in the jaw or back.
It may also happen that you get a lowered or raised blood pressure, bradycardia (slow heart rate ), tachycardia (fast heart rate ), vomiting, diarrhea, or pain in the arms or legs. An increase in blood pressure et decreased or increased pulse, and pain in the arms or legs. If any of these occur when you have used too much Ventavis, you should:
- interrupt inhalation a
- contact your doctor.
Your doctor will examine you and treat any symptoms that arise. No specific antidote is known.
If you forget to use Ventavis
Do not take a double dose to make up for a missed dose. Ask your doctor what to do.
If you stop using Ventavis
If you stop or want to stop using Ventavis, you should first discuss it with your doctor.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following serious side effects may occur. If this happens, contact a doctor immediately.
Very common (may affect more than 1 in 10 users):
- Bleeding (mostly nosebleeds ( epistaxis ) and coughing up blood (hemoptysis)) can occur very often, especially if you are also taking blood-thinning medicines ( anticoagulants ). The risk of bleeding may increase in patients when antiplatelet agents or anticoagulants are given concomitantly (see also section 2). Very rare, fatal cases of bleeding in the brain (cerebral and intracranial bleeding) have been reported.
Common (may affect up to 1 in 10 users):
- Fainting ( syncope ) is a symptom of the disease itself, but can also occur during treatment with Ventavis. (See also section 2, “Warnings and precautions”, for advice on what you can do to avoid this).
- Low blood pressure ( hypotension ).
Has been reported (occurring in an unknown number of users):
- Bronchospasm (sudden contraction of the muscles in the wall of the smaller airways) and wheezing (see also section 2 “Warnings and precautions”).
Below is a list of other possible side effects ordered by how likely they are:
Very common (may affect more than 1 in 10 users):
- widening of blood vessels ( vasodilatation ). The symptoms can be hot flashes or facial flushing.
- chest discomfort/chest pain
- cough
- headache
- nausea
- pain in the jaws/spasm in the jaw muscles (trismus)
- swelling of the arms, hands, legs, and feet (peripheral edema)
Common ( may affect up to 1 in 10 users):
- difficulty breathing ( dyspnea )
- dizziness
- vomiting
- diarrhea
- pain when swallowing ( pharyngeal irritation)
- throat irritation
- irritation including pain in the mouth and tongue
- rash
- fast heart rate ( tachycardia )
- palpitation _ _
Has been reported (occurring in an unknown number of users):
- decrease in the number of blood platelets ( thrombocytopenia )
- hypersensitivity ( allergy )
- taste disturbance ( dysgeusia )
Other possible side effects are
- Swelling of mainly ankles and legs due to accumulation of fluid (peripheral edema) is a very common symptom of the disease itself, but can also occur during treatment with Ventavis.
How Ventavis should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging and ampoule.
No special storage instructions.
Any Ventavis solution that remains in the nebulizer after inhalation must be thrown away.
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 iloprost.
1 ml of solution contains 10 micrograms of iloprost (in the form of iloprost trometamol).
Each ampoule of 1 ml contains 10 micrograms of iloprost.
Each ampoule of 2 ml contains 20 micrograms of iloprost. - Other ingredients are trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
Appearance and package sizes of the medicine
Ventavis is a clear, colorless nebulizer solution for inhalation with the Breelib, I‑Neb, or Venta‑Neb nebulizer.
Ventavis 10 micrograms/ml is supplied in clear ampoules containing either 1 ml or 2 ml solution for nebulizer.
Ventavis 10 micrograms/ml is available in the following packs:
- 1 ml ampoules for use with nebulizers Breelib or I‑Neb:
- Pack of 30 or 42 ampoules for use with Breelib and I‑Neb nebuliser .
- Multipack of 168 (4×42) ampoules for use with Breelib and I‑Neb nebulizer.
- Multipack of 168 (4×42) ampoules with Breelib set of consumables (containing 1 mouthpiece and 1 medicine container).
The ampoules containing 1 ml are marked with two colored rings (white-yellow).
- 2 ml ampoules for use with Venta‑Neb:
- A pack containing 30, 90, 100, or 300 ampoules.
- Multiple packaging with 90 (3×30) or 300 (10×30) ampoules .
The ampoules containing 2 ml are marked with two colored rings (white-pink).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Berlind SA
Francisco Alonso 7
Poligono Industrial Santa Rosa
28806 Alcala de Henares
Madrid
Spain