Combitimor

Package leaflet: Information for the user

COMBITIMOR 3mg/ml + 1mg/ml eye drops, solution

Tobramycin and Dexamethasone
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Combitimor is and what it is used for
2. What you need to know before using Combitimor
3. How to use Combitimor
4. Possible side effects
5. How to store Combitimor
6. Contents of the pack and other information

1. What Combitimor is and what it is used for

Combitimor contains a combination of two substances: dexamethasone and tobramycin.
Dexamethasone belongs to the class of corticosteroids and has an anti-inflammatory action,
while tobramycin is an antibiotic that acts against various bacteria that can cause eye infections.
Combitimor is indicated in adults and children from two years of age onwards for the treatment of eye inflammations when a corticosteroid is required and when there is an existing eye infection or a risk of eye infection.

2. What you should know before using Combitimor

Do not use Combitimor:

• if you are allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have corneal inflammation (the transparent membrane covering the front part of the eye) caused by the Herpes Simplex virus (herpes simplex keratitis);
• in case of vaccinia, chickenpox, or other viral infections of the cornea and conjunctiva (the transparent membrane covering the front part of the eye and the inner surface of the eyelids);
• if you have fungal (mycosis) eye infections, or untreated parasitic eye infections;
• if you have eye infections caused by mycobacteria (ocular tuberculosis);
• if you have high pressure inside the eye (endocular hypertension);
• if you have acute purulent eye inflammation (acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis), which may be masked or worsened by the use of this medicine;
• if you have inflammation of the sebaceous glands at the base of the eyelashes (hordeolum).

Warnings and precautions
Talk to your doctor or pharmacist before using Combitimor.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin administered into the eyes may occur, manifesting as local reactions (itching, redness) up to generalized allergic reactions (anaphylactic reactions). If these symptoms occur during the use of Combitimor, stop treatment and consult your doctor. Also note that this allergic sensitivity may occur with other antibiotics belonging to the aminoglycoside class, whether administered into the eyes or systemically (by injection);
• Consult your doctor if you have or have ever had conditions such as severe myasthenia gravis or Parkinson’s disease. This type of antibiotics may worsen muscle weakness.
• In patients who have received aminoglycoside antibiotics such as tobramycin systemically (by injection), serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using Combitimor together with aminoglycoside antibiotics taken systemically (by injection);
• Prolonged use of corticosteroids in the eyes may cause increased intraocular pressure (including a condition called glaucoma, with damage to the optic nerve), vision problems, and cataract formation (clouding of the lens inside the eye, known as crystalline lens). If you use Combitimor for a prolonged period, you must have regular and frequent checks of your eye pressure. This is particularly important in children, as the risk of corticosteroid-induced increase in intraocular pressure may be higher in children under six years of age and may occur earlier than in adults. Seek medical advice, especially if Combitimor needs to be used in children. The risk of corticosteroid-induced increase in intraocular pressure and/or cataract formation is increased in predisposed patients (e.g., diabetic patients);
• Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Combitimor. Consult your doctor before stopping treatment on your own. These risks are particularly relevant in children and in patients treated with a medicine called ritonavir or cobicistat;
• With the use of Combitimor, you may become more susceptible to eye infections caused by bacteria, viruses, fungi, or parasites: if your symptoms worsen or suddenly reappear, consult your doctor;
• If you have a corneal ulcer that does not heal, discontinue therapy and consult your doctor;
• Consult your doctor before using this medicine if you suffer from diseases causing thinning of eye tissues, as ocular administration of corticosteroids may lead to perforation;
• Corticosteroids applied to the eyes may delay healing of corneal wounds. It is also known that NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes slow down or delay healing. Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with eye wound healing (see section “Other medicines and Combitimor”);
• Do not wear contact lenses during treatment for eye inflammation or infection. Also read the section “Combitimor eye drops, solution in multidose bottle contains benzalkonium chloride”;
• Use Combitimor under direct medical supervision;
• Use Combitimor eye drops only for ocular application.
• Contact your doctor if blurred vision or other visual disturbances occur.

Children
Do not use Combitimor in children under 2 years of age, as the safety and efficacy of the medicine have not been demonstrated in this age group (see “Do not use Combitimor”).
During treatment, children should undergo frequent ophthalmological examinations, especially if under 6 years of age, due to the risk of steroid-induced increase in intraocular pressure (see “Warnings and precautions”).

Other medicines and Combitimor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are using other eye medications containing NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with corneal wound healing. If you are using other eye drops, wait at least 5 minutes between instillation of each medication.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase blood levels of dexamethasone.

Incompatibilities
The component tyloxapol contained in Combitimor is incompatible with tetracycline. Do not use Combitimor together with other eye products containing tetracycline.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Data on the use of tobramycin or dexamethasone in the eyes during pregnancy are lacking or limited. Animal studies have shown reproductive toxicity following systemic (oral or injectable) administration of dexamethasone and tobramycin.
Combitimor is not recommended during pregnancy. Consult your doctor, who will decide whether you should use Combitimor during pregnancy.

Breastfeeding
It is not known whether tobramycin or dexamethasone are excreted in breast milk after ocular administration. Tobramycin is excreted in breast milk after systemic administration (oral or injectable). Risk to infants cannot be ruled out. Combitimor eye drops should not be used during breastfeeding. Consult your doctor, who will assess whether it is appropriate to use Combitimor during breastfeeding.

Fertility
No studies have been conducted to evaluate the effect of ocular administration of tobramycin on human or animal fertility. Clinical data evaluating the effect of ocular administration of dexamethasone on male or female fertility are limited.

Driving and using machines
For a certain period after instillation of Combitimor, blurred vision or other visual disturbances may occur, which could impair your ability to drive or operate machinery. If these effects occur, wait until your vision clears before driving or using machinery.

Combitimor eye drops, solution in multidose bottle contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per bottle, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use Combitimor

Apply Combitimor eye drops only into the eyes.
Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose: 1 or 2 drops 4-5 times a day, following your doctor's instructions. Use the product for the length of time prescribed by your doctor.
The following procedure helps limit the amount of medicine that passes into the bloodstream after eye application: keep the eyelid closed and simultaneously apply gentle pressure with a finger at the inner corner of the eye near the nose.

Use in children
Do not use Combitimor eye drops in children under two years of age, as safety and efficacy have not been established and no data are available in this population.
Combitimor may be used in children from the age of 2 years at the same doses as recommended for adults.

How to apply Combitimor eye drops

• Wash your hands.
• If you wear contact lenses, remove them before instilling the drops and wait at least 15 minutes before reinserting them.
• Hold the bottle/container upside down between your thumb and middle finger.
• Tilt your head backward. Pull down the eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch.
• Bring the tip of the bottle/container close to the eye.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle/container to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle/container to release one drop of Combitimor at a time.
• If a drop does not enter the eye, try again.
• After using COMBITIMOR, keep your eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose. This helps reduce the absorption of COMBITIMOR into the rest of the body.
• If instilling drops into both eyes, repeat the same procedure for the other eye.

Eye drops, solution in multidose bottle:

• Immediately replace the cap after use, screwing it back on tightly.
• The eye drops must be used within 28 days after first opening the bottle.

Eye drops, solution in single-dose containers:

• Discard the container and any remaining contents.
• The product must be used within 28 days after opening the aluminum pouch.

If you use more Combitimor than you should
If an excessive dose of Combitimor is accidentally ingested or taken orally, inform your doctor immediately or go to the nearest hospital.
Considering that the medicine is administered into the eyes, overdose is unlikely. However, if this should occur, thoroughly rinse the eye with running water.
Do not use the medicine again until the next scheduled dose.

If you forget to use Combitimor
If you forget to use Combitimor, do not worry; apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of tobramycin and dexamethasone ophthalmic solution.

Uncommon side effects ( may affect up to 1 in 100 people )

• increased pressure in the eye(s);
• eye pain;
• eye itching;
• eye discomfort;
• eye irritation.

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

• inflammation of the surface of the eye;
• eye allergy;
• dry eye;
• eye redness;
• unpleasant taste.

Side effects of unknown frequency ( frequency cannot be estimated from the available data )

• swelling of the eyelids;
• redness of the eyelids;
• increase in pupil size;
• increased tear production;
• blurred vision;
• allergy (hypersensitivity);
• dizziness;
• headache;
• nausea;
• abdominal discomfort;
• skin rash;
• facial swelling;
• itching;
• erythema multiforme;
• Hormonal problems: increased body hair growth (especially in women), weakness and muscle atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).

Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Combitimor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
The expiry date applies to the product stored in its original, unopened packaging and kept under recommended storage conditions.
This medicine does not require any special storage precautions.

Shelf life after opening
Single-dose containers
Use this medicine immediately after opening the single-dose container. Discard any remaining solution.
The product must be used within 28 days of opening the aluminium pouch.

5 ml multidose bottle
The product must be used within 28 days of the first opening of the bottle.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Combitimor contains
Single-dose containers

• The active substances are tobramycin and dexamethasone. Each single-dose container contains 0.75 mg of tobramycin and 0.329 mg of dexamethasone sodium phosphate (equivalent to 0.25 mg of dexamethasone).
• The other components are: tyloxapol, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

5 ml multidose bottle

• The active substances are tobramycin and dexamethasone. A 5 ml bottle contains 15 mg of tobramycin and 6.58 mg of dexamethasone sodium phosphate (equivalent to 5 mg of dexamethasone).
• The other components are: tyloxapol, benzalkonium chloride, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

Description of the appearance of Combitimor and contents of the pack
Combitimor is an eye drop solution.
20 single-dose containers of 0.25 ml.
1 5 ml dropper bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

Patient information leaflet

Combitimor 3 mg/ml + 1 mg/ml ear drops, solution

Tobramycin and Dexamethasone
Equivalent medicinal product
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Combitimor is and what it is used for
2. What you need to know before using Combitimor
3. How to use Combitimor
4. Possible side effects
5. How to store Combitimor
6. Contents of the pack and other information

1. What Combitimor is and what it is used for

Combitimor contains a combination of two substances: dexamethasone and tobramycin. Dexamethasone belongs to the class of corticosteroids and has anti-inflammatory properties, while tobramycin, which belongs to the class of aminoglycoside antibiotics, acts against various bacteria that can cause ear infections.
Combitimor is used in adults and children over 2 years of age for the treatment of inflammation of the external auditory canal (external otitis) when an anti-inflammatory agent (corticosteroid) is required, in cases of infection caused by bacteria sensitive to tobramycin or when there is a risk of infection.

2. What you need to know before using Combitimor

Do not use Combitimor

• if you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have skin diseases caused by bacterial infections (cutaneous tuberculosis) or viral infections (Herpes simplex) or other viral diseases affecting the skin, or fungal ear infections (otomycosis);
• if you have or suspect a perforated eardrum;
• if you are breastfeeding (see "Pregnancy and breastfeeding");
• in children under 2 years of age (see "Children").

Warnings and precautions

• Consult your doctor before using Combitimor;
• Use Combitimor only in the ear; do not inject it;
• Before applying Combitimor drops, clean the ear canal;
• During treatment with Combitimor, follow the usual precautions related to corticosteroid use as advised by your doctor;
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. Antibiotics of this type may worsen muscle weakness;
• In patients who have received systemic (injected) aminoglycoside antibiotics such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using Combitimor together with systemic (injected) aminoglycoside antibiotics;
• With local administration of corticosteroids, adverse effects usually associated with systemic (oral or injected) corticosteroid use may occur, including reduced activity of the adrenal glands, especially in children (see "Children");
• The tobramycin contained in Combitimor may cause toxic effects in the ear: if, after instillation of Combitimor, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear), or hearing loss occur, stop treatment immediately and consult your doctor;
• To reduce the risk of toxic effects, do not apply Combitimor to wounds or burns and do not use the medicine for more than 7 days;
• Prolonged use of antibiotics such as tobramycin may promote the growth of microorganisms against which the medicine is no longer effective, including fungi. If you do not notice improvement in your condition within a short time, stop using the medicine and consult your doctor;
• If you are simultaneously taking tobramycin or other systemic (injected) aminoglycoside antibiotics while using Combitimor, your doctor may perform blood tests to monitor the total amount of antibiotic in your blood;
• If irritation or sensitization (allergic reaction) occurs, stop treatment and consult your doctor. Sensitization may also occur with the use of other antibiotics belonging to the aminoglycoside class, whether administered locally or systemically (by injection);
• Increased medical monitoring is required in elderly patients, patients already receiving aminoglycoside antibiotics, patients with kidney disease, and those receiving concomitant treatment with loop diuretics;
• Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are often the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Combitimor. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat;
• Contact your doctor if blurred vision or other visual disturbances occur.

Children
Do not use Combitimor in children under 2 years of age (see "Do not use Combitimor").
Children may be more sensitive than adults to the adverse effects of corticosteroids, even after local administration.
Alterations in the function of the hypothalamic-pituitary-adrenal (HPA) axis (HPA axis suppression), a condition related to prolonged exposure to cortisol (Cushing's syndrome), delayed growth in height and body weight, and increased intracranial pressure with headache and bulging fontanelles (areas of the skull where bones have not yet fused) may occur.
Follow your doctor's instructions exactly when administering Combitimor to a child.

Other medicines and Combitimor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the blood levels of dexamethasone.

Incompatibilities
The component tyloxapol, contained in Combitimor ear drops, is incompatible with tetracyclines. Do not use Combitimor together with other ear medicines containing tetracyclines.

Driving and using machines
No effects of Combitimor on the ability to drive or operate machinery are known.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility
No studies have been conducted to evaluate the effect of Combitimor administration on human fertility.

Pregnancy
Data on the use of tobramycin or dexamethasone in the ears of pregnant women are lacking or limited in number. Therefore, during pregnancy, the use of Combitimor should be decided by the doctor, who will weigh the benefits for the mother against the risks for the fetus.

Breastfeeding
It is not known whether tobramycin or dexamethasone administered into the ears is excreted in breast milk. Corticosteroids and tobramycin are excreted in breast milk following oral or systemic (injected) administration. Risk to the infant cannot be excluded. The use of Combitimor is contraindicated during breastfeeding.

Combitimor ear drops, solution in multidose bottle contains benzalkonium chloride
The multidose bottle of this medicine contains 0.5 mg of benzalkonium chloride per bottle, equivalent to 0.1 mg/ml.
Benzalkonium chloride may irritate the skin.

3. How to use Combitimor

Apply Combitimor ear drops only into the ears.
Always use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Adults and children over 2 years of age
The recommended dose is four drops three times daily, or as otherwise directed by a physician. Instill Combitimor ear drops into the external auditory canal. Do not use the medicine for longer than 7 days (see section 2 “Warnings and precautions”).
How to apply Combitimor

• Wash your hands.
• Hold the bottle/container with the opening facing downward, using your thumb and middle finger.
• Lie down with the affected ear facing upward.
• Bring the tip of the bottle/container close to the ear canal.
• Avoid contact between the tip of the bottle/container and the earlobe, ear canal, surrounding areas, or any other surfaces: this could contaminate the drops.
• Gently squeeze the base of the bottle/container to release one drop of Combitimor at a time.
• If a drop does not enter the ear, try again.
• If using drops in both ears, repeat the procedure for the other ear.
• Ear drops, solution in multidose bottle:
• Immediately replace the cap after use, making sure it is tightly screwed on.
• The product should be used within 28 days after first opening the bottle.
• Ear drops, solution in single-dose containers:
• Discard the container and any remaining contents.
• The product should be used within 28 days after first opening the aluminum pouch.

If you use more Combitimor than you should
If you use more Combitimor than prescribed, consult your doctor or pharmacist.
Excessive or prolonged use of topical corticosteroids may lead to Cushing's syndrome, particularly weakness (asthenia), adynamia (marked weakness), increased blood pressure, cardiac rhythm disturbances, decreased potassium levels in the blood, and metabolic alkalosis (increased blood pH).
If you forget to use Combitimor
If you forget to use Combitimor, do not worry—apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• ear toxicity (ototoxicity) (frequency not known*);
• allergic reactions (local hypersensitivity). In such cases, discontinue treatment and consult your doctor;
• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or missed menstrual periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (frequency not known*; see section 2, “Warnings and precautions”);
• blurred vision (frequency not known*).

*Frequency not known (frequency cannot be estimated from the available data)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Combitimor
   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 packaging after “Exp”. The expiry date refers to the last day of the stated month. The expiry date applies to the product stored in its original intact packaging and kept under proper storage conditions.

This medicine does not require any special storage precautions.
Shelf life after opening
Single-dose containers
Use the medicine immediately after opening the single-dose container. Discard any remaining solution.
The product must be used within 28 days after opening the aluminium pouch.
Multi-dose bottle, 5 ml
The product must be used within 28 days after first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Combitimor contains
Single-dose containers

• The active substances are tobramycin and dexamethasone. Each single-dose container contains 0.75 mg of tobramycin and 0.329 mg of dexamethasone sodium phosphate (equivalent to 0.25 mg of dexamethasone).
• The other components are: tyloxapol, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

5 ml multidose bottle

• The active substances are tobramycin and dexamethasone. A 5 ml bottle contains 15 mg of tobramycin and 6.58 mg of dexamethasone sodium phosphate (equivalent to 5 mg of dexamethasone).
• The other components are: tyloxapol, benzalkonium chloride, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

Description of the appearance of Combitimor and package contents
Combitimor is an ear drop solution.
20 single-dose containers of 0.25 ml.
1 5 ml dropper bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)