TAPTICOM® (Tapticom)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTafluprost + TimololTafluprost + Timolol
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  • TAPTICOM®
    drops d / eye 
    Santen, AO     Finland
    • Dosage form: & nbspeye drops
    Composition:

    1 ml of the preparation contains:

    Active substances: tafluprost 15.0 μg and timolol maleate 6.84 mg (in terms of timolol 5.0 mg).

    Excipients: glycerol 22.5 mg, disodium hydrophosphate 4.9 mg, disodium edetate 0.5 mg, polysorbate 80 0.75 mg, sodium hydroxide 0.04-0.06 mg or hydrochloric acid 0.0- 0.2 mg to adjust the pH, water for injection to 1 ml.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:Antiglaucoma combined (prostaglandin E2-alpha analogue synthetic + beta-blocker)
    ATX: & nbsp

    S.01.E.D.51   Timolol in combination with other drugs

    Pharmacodynamics:

    TAPTICOM® - A medicinal product containing a fixed combination of two active substances - tafluprost and timolol. Both active substances reduce intraocular pressure (IOP), mutually enhancing the effect of each other, as a result of which the effect of reducing IOP when using a combination drug is more pronounced than the effect of each of the active substances alone.

    Tafluprost - fluorinated analog prostaglandin F2α. Acid tafluprost, being a biologically active metabolite tafluprost, has a high activity and selectivity for FPhuman receptors (prostaglandin receptors F2α). Data from pharmacodynamic studies (preclinical studies) indicate that tafluprost reduces IOP, strengthening uveoscleral outflow of watery moisture. Timolola maleate is a non-selective beta-blocker. The precise mechanism for reducing IOP when applied timolol maleate At present, it has not been fully established, however, the methods of fluorescence and tonography indicate that the main effect may be due to a decrease in the formation of the intraocular fluid. At the same time, in some studies, there was a slight increase in its outflow. It was shown that in patients with open-angle glaucoma or ocular hypertension and an average IOP value before treatment 24-26 mm Hg. Art. the effect of reducing IOP on the background of the use of the drug Tapticom® was no less than the effect observed with the combined application of 0.0015% of tafluprost and 0.5% of timolol, and a decrease in the mean daily IOP at 6 months was 8 mm Hg. Art. of the original values.

    In addition, the activity of Tapticom® and corresponding monotherapy drugs were compared in patients with open-angle glaucoma or ophthalmic hypertension and mean IOP before treatment, 26-27 mm Hg. Art.Decrease in the mean daily IOP on the background of the use of the drug TAPTICOM® was statistically more significant than that against a background of monotherapy with tafluprost, applied once a day, in the morning, or timolol, applied twice a day. After 3 months of treatment, the decrease in the mean daily IOP in comparison with its baseline in the Tapticom® group was 9 mm Hg. Art. compared with 7 mm Hg. observed in both groups of monotherapy. Decrease in IOP in patients using TAPTICOM® during the day fluctuated between 7 and 9 mm Hg. Art.

    The combined data of these two clinical trials in patients (n=168) with initially high IOP from 26 mm Hg. Art. or above showed that in patients receiving TAPTICOM® after 3 or 6 months, the mean 24-hour IOP decrease was 10 mm of mercury. with a range of 9 to 12 mm Hg. Art. during the day.

    Pharmacokinetics:

    Absorption

    In the blood plasma of healthy volunteers, the concentrations of tufluprost acid and timolol were determined after a single and repeated application within 8 days of the drug TAPTICOM® in the form of eye drops (once a day), as well as 0.0015% tafluprost (1 time in day) and 0.5% timolol (2 times a day). It revealed,that the maximum concentration of tafluprost acid in the blood plasma is reached by the 10th minute after application of the drug Tapticom® (the time to reach the maximum concentration, TmOh), followed by its decrease below the sensitivity threshold of the method (10 pg / ml) for about 30 min. The accumulation of tafluprost acid was negligible and on the 8th day of treatment average values ​​of the indices AUC0-last (area under the concentration-time curve) (monotherapy: 4.45 ± 2.57 pg / hr, Tapticom®: 3.60 ± 3.70 pg / hr / ml) and CmOh (monotherapy: 23.9 ± 11.8 pg / ml, Tapticom®: 18.7 ± 11.9 pg / ml) were slightly lower with Tapticom® compared with tafluprost alone. The concentration of timolol in the blood plasma after instillation of the drug Tapticom® on the first and the eighth day reached a maximum after 15 minutes and 37.5 minutes (median TmOh), respectively. On the eighth day the value AUC0-last timolol (monotherapy: 5750 ± 2440 pg * h / ml; Tapticom®: 4560 ± 2980 pg * h / ml) and mean CmOh (monotherapy: 1100 ± 550 pg / ml, Tapticom®: 840 ± 520 pg / ml) were slightly lower with Tapticom® than with timolol monotherapy. The lower concentration of timolol in the blood plasma with the use of the drug Tapticom® is explained by its single application per day, while with monotherapy timolol applied 2 times a day.

    Absorption of tafluprost and timolol is carried out through the cornea. Based on the results of preclinical studies, it was found that the penetration of tafluprost from Tapticom® through the cornea was comparable to its penetration with tafluprost in monotherapy once a day, while the penetration of timolol from Tapticom® was slightly lower than with timolol monotherapy . Concentration AUC4-haca tafluprost acids after instillation of Tapticom® was 7.5 ng / hr and 7.7 ng / h / ml after instillation of the tafluprost monotherapy. The concentration of timcall A and C4 hours after the use of the Tapticom® preparation and the monotherapy drug was 585 ng * h / ml and 737 ng * h / ml, respectively. TmOh acid tafluprost is 60 minutes, both with the use of the drug Tapticom®, and in monotherapy with tafluprost, and TmOh timolol is 60 minutes with Tapticom® and 30 minutes in timolol monotherapy.

    Distribution

    Tafluprost

    According to preclinical studies, the distribution of tafluprost, labeled with a radioisotope, in the tissues of the eye suggests that tafluprost has a low affinity for the melanin pigment.

    Autoradiography showed that the highest concentration of radioactivity was observed in the cornea, followed by eyelids, sclera, and the iris. The distribution of radiolabeled tafluprost in other organs was as follows: tear apparatus, palate, esophagus, gastrointestinal tract, kidneys, liver, gallbladder and urinary bladder. Binding of tafluprost acid to human serum albumin in vitro was 99% at a concentration of 500 ng / ml of tafluprost acid.

    Timolol

    According to preclinical studies, the maximum concentration of timolol with a radioactive label in aqueous humor is achieved 30 minutes after a single administration of timolol containing a radioactive 'H isotope (0.5% solution: 20 μl / eye). Timolol is derived from watery moisture much faster than from the pigment-containing tissues of the iris and the ciliary body.

    Metabolism

    Tafluprost

    The main way of metabolism of tafluprost in the human body, confirmed by studies in vitro, is hydrolysis with the formation of a pharmacologically active metabolite, tafluprost acid, which is then metabolized by glucuronidation or beta oxidation.Products of beta oxidation are pharmacologically inactive 1,2-dinor and 1,2,3,4-tetranor of tafluprost acid, which may be glucuronated or hydroxylated. The enzymatic system of cytochrome P450 does not participate in the metabolism of tafluprost acid. In a study conducted on rabbit corneal tissues with refined enzymes, it was found that carboxyl esterase is the main esterase responsible for the etheric hydrolysis of tafluprost to tafluprost acid. Butyrylcholinesterase can also promote hydrolysis.

    Timolol

    Timolol is metabolized in the liver with the participation of isoenzyme CYP2D6 cytochrome P450 with the formation of inactive metabolites, which are excreted mainly by the kidneys.

    Excretion

    Tafluprost

    In a study in rats it was found that after instillation 3H-tafluprost in the form of 0.005% ophthalmic solution in both eyes once a day for 21 days, about 87% of the total radioactive dose is excreted through the excretory organs. Approximately 27-38% of the total dose was excreted by the kidneys, and about 44-58% - through the gastrointestinal tract.

    Timolol

    The expected half-life of plasma is about 4 hours. After oral administration timolol gradually metabolized in the liver, and metabolites are excreted in the urine together with 20% of unchanged timolol.

    Data on the excretion of timolol were obtained by its oral administration.

    Indications:

    Decrease in intraocular pressure (IOP) in adult patients with open-angle glaucoma or intraocular hypertension with insufficient response to local monotherapy with drugs of beta-adrenoblocker or prostaglandin analogues in cases when combination therapy is indicated, as well as in patients whose use is expected to improve the tolerability of treatment due to the use of eye drops that do not contain preservatives.

    Contraindications:

    - Hypersensitivity to tafluprost, timolol or any of the components of the drug;

    - Syndrome of increased reactivity of the respiratory tract, including bronchial asthma or anamnesis of bronchial asthma, severe chronic obstructive pulmonary disease;

    - Sinus bradycardia, syndrome of weakness of the sinus node, including sinoatrial blockade of the heart, atrioventricular blockade of II and III degree without a pacemaker;

    - Decompensated heart failure, cardiogenic shock;

    - Age under 18 years (no clinical use data available);

    - Pregnancy;

    - Breast-feeding.

    Carefully:

    Tapticom® should be used with caution because of limited experience in patients with hepatic and renal insufficiency, in patients with aphakia, pseudophakia with rupture of the posterior capsular lens or lens implantation in the anterior chamber of the eye, pseudoexfoliation or pigmentary glaucoma, as well as in patients with established risk factors for cystoid macular edema or iritis / uveitis. There is no experience with tafluprost in neovascular, occlusive, narrow-angle and congenital glaucoma.

    The drug should also be used with caution in patients with corneal diseases (can cause dry eye syndrome), cardiovascular diseases (coronary heart disease, prinzmetal angina, heart failure, atrioventricular blockade of the I degree), peripheral circulation disorders (in severe forms of the disease Reynaud or Reynaud syndrome), chronic obstructive pulmonary disease (COPD) of mild to moderate severity (use of the drug is only possible if the expected benefit exceeds the potential risk),labile course of diabetes mellitus or spontaneous hypoglycemia (since beta-adrenoblockers can hide the clinical signs and symptoms of acute hypoglycemia), concomitant treatment with beta-blockers (with ingestion and as eye aids).

    Pregnancy and lactation:

    Pregnancy

    There are no adequate data on the use of TAPTICOM® in pregnant women.

    Women of childbearing age should use effective methods of contraception during the treatment with the drug Tapticom®.

    Do not use TAPTICOM ® during pregnancy, except in special cases (unless other methods of treatment are available).

    Tafluprost

    There are no adequate data on the use of tafluprost in pregnant women. Tafluprost may have adverse pharmacological effects on the course of pregnancy and / or on the development of a fetus or newborn baby. In animal studies, there is evidence of reproductive toxicity tafluprost, at the same time, the potential risk of its use in humans is not known.

    Timolol

    Adequate data on the use of timolol in pregnant women are absent.Tapticom® should not be used in pregnant women unless the expected benefit to the mother exceeds the potential risk to the fetus.

    Information on measures to reduce systemic absorption is presented in the section "Method of administration and dose".

    In epidemiological studies, there was no systemic impairment of fetal development, but there was a risk of a retardation of intrauterine development in the case of taking beta-adrenoblockers inside. In addition, clinical manifestations and symptoms of beta-adrenergic blockade (for example, bradycardia, hypotension, respiratory disorders and hypoglycemia) were observed in newborns if beta-blockers were used before delivery. If you use Tapticom ® before delivery, you should carefully monitor the condition of the newborn during the first days of life.

    Breast-feeding

    It is known that beta-blockers penetrate into breast milk. However, it is unlikely that with the use of timolol in the eye drops at recommended therapeutic doses, sufficient amounts of the substance can penetrate into breast milk to cause symptoms of beta-adrenergic blockade in the infant.Information on measures to reduce systemic absorption is presented in the section "Method of administration and dose".

    There is no data on the excretion of tafluprost or its metabolites into human breast milk. The available toxicological data in animals indicate a possible excretion of tafluprost and its metabolites into breast milk. However, it is unlikely that with tafluprost in the eye drops at recommended therapeutic doses, sufficient amounts of the substance will penetrate into breast milk to cause clinical symptoms in the infant.

    For the purpose of precaution, breastfeeding of children is not recommended if the mother requires therapy with Tapticom ®.

    Fertility

    There is no evidence of the effect of Tapticom® on fertility (fertility) in humans.

    Dosing and Administration:

    The drug is intended for ophthalmic use only.

    The recommended dose is one drop of Tapticom® in the conjunctival sac of the affected eye (eye) once a day.

    Dose should not exceed one drop in the affected eye (eye) per day, as more frequent use of the drug may reduce the expected effect of reducing intraocular pressure.

    If one dose is missed, the treatment is continued from the next scheduled dose.

    Tapticom® is a sterile solution that does not contain preservatives, packaged in disposable tube-droppers. The solution in one tube-drip is intended only for single use, and its quantity is sufficient for application in both eyes.

    Special patient groups

    Children

    The use of Tapticom ® in children under the age of 18 is not recommended.

    Elderly patients

    Older patients do not need a dose adjustment.

    Patients with renal / hepatic insufficiency

    The use of the drug Taptikom ® has not been studied in patients with renal and hepatic insufficiency, so use the drug in such patients should be cautious.

    Mode of application

    To reduce the risk of darkening the skin of the eyelids, patients should remove excess solution from the skin.

    As with the application of other eye drops, with a brief finger compression of the nasolacrimal canals or the closing of the eyelids for 2 min after application, the systemic absorption of the drug decreases.Such a measure reduces the risk of systemic side effects and strengthens the local effect of the drug.

    When using several local ophthalmic drugs, the intervals between their use should be at least 5 minutes.

    Contact lenses should be removed before use, again they can be put on after 15 minutes.

    Patients should be warned that they should not touch the eye and surrounding tissues with the tip of a dropper, as this can damage them.

    After opening the package with a tube-dropper:

    - Eye drops should be used within 4 weeks after opening the package.

    - Keep the tube-dropper in the dark place, in the package.

    - Eye drops should be stored at a temperature of no higher than 25 ° C.

    - After a single use, the tube-dropper should be discarded together with the rest of the drug.

    If the rules of storing eye preparations are not observed, their bacterial contamination is possible, which can lead to the development of bacterial infections of the visual organ, potentially capable of leading to a significant deterioration of vision or its loss.

    Side effects:

    In clinical trials, more than 484 patients were treated with TAPTICOM®. The most common adverse effect associated with treatment, occurring in approximately 7% of patients, was conjunctival / eye hyperemia, in most cases mild. The undesirable reactions observed in the clinical studies of the Tapticom® drug were limited to the same reactions that were previously observed with the separate use of tafluprost and timolol. New unwanted reactions, characteristic only for the drug Tapticom ®, in clinical studies have been identified. The majority of undesirable reactions were observed from the side of the organ of vision, had an easy or moderate degree, serious reactions were not noted.

    To estimate the frequency of undesired reactions, according to the terminology MEDDRA, the following classification was used: very often (≥ 1/10 cases); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10000, <1/1000); very rarely (<1/10000) and unknown (the frequency can not be determined from the available data).

    Tapticom® (combination of tafluprost and timolol)

    Infringements from nervous system

    Infrequently: headache.

    Disturbances on the part of the organ of sight

    Often: congestion / eye hyperemia, itching in the eyes, eye pain, eyelash changes (increase in length, thickness and number of eyelashes), eyelash color change, eye irritation, foreign body sensation in the eyes, blurred vision, photophobia.

    Infrequently: unpleasant sensations in the eyes, dry eye mucosa, a feeling of discomfort in the eyes, conjunctivitis, erythema eyelids, allergic eye damage symptoms, eyelid edema, superficial punctate keratitis, lacrimation, inflammatory reaction in the anterior chamber moisture, asthenopia, blepharitis.

    Undesirable reactions that were observed during the treatment period tafluprost or timolol, and which can potentially develop with Tapticom®:

    Tafluprost

    Disorders from the side of the organ of vision: decreased visual acuity, increased pigmentation of the iris, eyelid pigmentation, conjunctival edema, appearance of the discharge from the eyes, cell opalescence in the anterior chamber of the eye, allergic conjunctivitis, conjunctival pigmentation, conjunctival follicles, deepening of the fold of the eyelid, iritis / uveitis.

    Disturbances from the skin and subcutaneous tissues: hypertrichosis century.

    Disturbance of the respiratory system: unknown: exacerbation of asthma, shortness of breath.

    Timolol

    Immune system disorders: allergic reactions, including angioedema, hives, local or generalized skin rash, anaphylaxis, skin itching.

    Infringements from metabolism and nutrition: hypoglycemia.

    Disorders of the psyche: depression, insomnia, nightmares, memory loss, nervousness.

    Impaired nervous system: dizziness, fainting, paresthesia, increased myasthenia gravis symptoms, acute cerebrovascular accident, cerebral ischemia.

    Disorders from the side of the organ of vision: keratitis, decreased corneal sensitivity, visual acuity, including refractive changes (in some cases, as a result of cancellation of myotectic therapy), ptosis, diplopia, vascular closure after fistulizing surgery (see section "Special instructions"), lacrimation, corneal erosion.

    Disturbances from the organ of hearing and balance: tinnitus.

    Heart Disease: bradycardia, chest pain, palpitations, edema, arrhythmia, congestive heart failure, cardiac arrest, heart block, atrioventricular blockade, heart failure.

    Vascular disorders: lowering blood pressure, intermittent claudication, the phenomenon of Raynaud, cold hands and feet.

    Disturbances from the respiratory system, chest and mediastinal organs: shortness of breath, bronchospasm (mainly in patients with a history of bronchospasm), respiratory failure, cough.

    Disorders from the gastrointestinal tract: nausea, dyspepsia, diarrhea, dryness of the oral mucosa, dysgeusia, abdominal pain, vomiting.

    Disturbances from the skin and subcutaneous tissues: alopecia, psoriasis-like rash or exacerbation of psoriasis, skin rash.

    Disturbances from the musculoskeletal and connective tissue: systemic lupus erythematosus, myalgia, arthropathy.

    Disorders from the reproductive system and mammary glands: Peyronie's disease, decreased libido, sexual dysfunction.

    General disorders: asthenia / fatigue. thirst.

    Very rarely, when eye drops containing phosphates were used, cases of calcification of the cornea were reported in some patients with severe corneal lesions.

    Overdose:

    No cases of drug overdose with TAPTICOM® have been reported. When instilling the drug in the eye, the appearance of overdose symptoms is unlikely.

    There have been reports of an unintended overdose of timolol, which led to the development of systemic effects similar to those in systemic use of beta-blockers, namely dizziness, headache, dyspnea, bradycardia, bronchospasm and cardiac arrest (also see "Side effect").

    If you have symptoms of an overdose with Tapticom®, symptomatic and supportive therapy is necessary. Removal of timolol in hemodialysis is slowed down.

    Interaction:

    Clinical studies on the interaction of the drug have not been conducted.

    Possible reduction in blood pressure and / or the emergence of clinically pronounced bradycardia in the case of simultaneous use of ophthalmic drugs containing beta-blockers,and systemic use of blockers of "slow" calcium channels, other beta-blockers, antiarrhythmics (including amiodarone), cardiac glycosides, parasympathomimetics, guanetidine.

    The intake of beta-adrenoblockers inside can lead to an increase in the "ricochet" arterial hypertension observed with the abolition of clonidine.

    With the simultaneous use of inhibitors of isoenzyme CYP2D6 (for example, quinidine, fluoxetine, paroxetine) and timolol reported increased systemic action of the beta-adrenoblocker (reduction in heart rate, depression). With the simultaneous use of ophthalmic drugs containing beta-adrenoblocker and epinephrine (epinephrine), in some cases, the pupil was enlarged.

    Special instructions:

    System Effects:

    Like other ophthalmic drugs, tafluprost and timolol are absorbed systemically. Due to the presence of the beta-adrenergic component of timolol in the composition of the drug, the same undesirable reactions from the cardiovascular and respiratory systems may occur, as with systemic beta-blockers.The incidence of systemic adverse reactions after topical application of eye drops is lower than after systemic administration. Information on measures to reduce systemic absorption is presented in the section "Method of administration and dose".

    Heart Disease:

    Patients with cardiovascular diseases (eg, coronary heart disease, Prinzmetal angina pectoris, heart failure) and arterial hypotension should carefully evaluate the need for beta-blocker therapy and consider the use of drugs from other groups. It is necessary to monitor the condition of patients with cardiovascular diseases in order to timely identify symptoms of worsening diseases and adverse reactions. Due to its negative effect on the speed of the pulse, beta-blockers should be used with caution in patients with stage I atrioventricular block.

    Vascular disorders:

    It is necessary to use the drug with caution in patients with severe impairment of peripheral circulation (for example, severe forms of Raynaud's disease or Raynaud's syndrome).

    Disturbances from the respiratory organs:

    After using some ophthalmic beta-blockers, the risk of unwanted respiratory reactions may increase, including deaths due to bronchospasm in patients with bronchial asthma. In patients with mild to moderate COPD, TAPTICOM® should be used with caution, and only if the expected benefit of its use outweighs the potential risk.

    Hypoglycemia / diabetes mellitus:

    Beta-blockers should be used with caution in patients prone to spontaneous hypoglycemia, or in patients with a labile course of diabetes mellitus, since beta-blockers can mask the signs and symptoms of acute hypoglycemia.

    Beta-blockers can also mask signs of hyperthyroidism. Abrupt withdrawal of therapy with beta-blocker can lead to worsening of the symptoms of the disease.

    Diseases of the cornea:

    Ophthalmic beta-blockers can promote the development of the "dry eye" syndrome. Care should be taken when using the drug in patients with corneal disease.

    Other beta-blockers:

    Influence on intraocular pressure or known effects of systemic blockade of beta-adrenoreceptors may be exacerbated by the use of timolol (one of the active substances of the drug Tapticom®) in patients already receiving a systemic beta-blocker. Care should be taken to monitor the condition of these patients. It is not recommended to use two local beta-blockers at the same time.

    Closed-angle glaucoma:

    In patients with angle-closure glaucoma, the primary goal of therapy is to open the angle of the anterior chamber of the eye. This requires a narrowing pupil miotic drug. Timolol has a minimal effect on the pupil, or does not have any effect. When timolol It is used to reduce the increased intraocular pressure in closed-angle glaucoma, it should be used in combination with a miotic agent, and not as a monotherapy.

    Anaphylactic reactions:

    When beta-blockers are used, patients with a history of atopy or a severe anaphylactic reaction to a number of allergens in the anamnesis may react more strongly to reintroducing such allergens and not respond to the usual doses of epinephrine used to treat anaphylactic reactions.

    Detachment of the choroid:

    There have been reported cases of detachment of the choroid with the use of drugs that suppress the production of aqueous humor (for example, timolol, acetazolamide) after fistulizing operations.

    General anesthesia:

    Ophthalmic beta-blockers can block the effects of systemic beta-adrenergic receptor agonists, for example, adrenaline. An anesthesiologist should be informed about the use of timolol by the patient.

    Before starting therapy, patients should be informed of the possible excessive eyelash growth, darkening of the eyelid skin, and increased pigmentation of the iris, which are associated with tafluprost therapy. Some of these changes may be permanent, and this can lead to differences in the appearance of the eyes, if only one eye has been treated.

    The change in iris pigmentation is slow and may not be noticeable for several months. The change in eye color is observed mainly in patients with iridescent colors of mixed colors, for example, if the eyes are brownish-blue, gray-brown, yellow-brown or green-brown. Treatment of only one eye can lead to persistent heterochromia.

    Effect on the ability to drive transp. cf. and fur:

    The effect of the drug Taptic on the ability to drive a car and work with mechanisms has not been studied. As with any other ophthalmic device, a short-term fogging may occur after application of the drug Therefore, it is necessary to refrain from driving vehicles and performing activities that require a high concentration of attention and speed of psychomotor reactions, before the restoration of vision.

    Form release / dosage:

    Eye drops 0.0015% + 0.5%.

    Packaging:

    For 0.3 ml per tube for single use of low-density polyethylene. 5 tube-droppers, welded together, in one strip.

    2 strips per package of aluminum-polyethylene foil, covered with paper. For 3 or 9 pack (s) along with instructions for medical use in a cardboard pack.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003372
    Date of registration:17.12.2015
    Expiration Date:17.12.2020
    The owner of the registration certificate: Santen, AO Santen, AO Finland
    Manufacturer: & nbsp
    Representation: & nbspSANTEN AS SANTEN AS Finland
    Information update date: & nbsp19.12.2017
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