natgillin/translations-raw huggingface dataset:
Дата на последно актуализиране на текста 03-2011.
This summary was last updated in 03-2011.
Европейската комисия издава разрешение за употреба, валидно в Европейския съюз, за Valtropin на BioPartners GmbH на 24 април 2006 г.
The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Valtropin се използва за лечение на деца в следните случаи:
Valtropin is used to treat children in the following situations:
Проучването е с продължителност 12 месеца и измерва ръста на децата в началото и края на проучването и скоростта на растеж по време на проучването.
The study lasted 12 months, and measured the children's height at the beginning and the end of the study, and the speed of growth during the study.
След 12 месеца на лечение Valtropin и Humatrope предизвикват сходно повишаване на ръста и скоростта на растеж (скорост от съответно +11,4 и +10,5 cm на година).
After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Пациентът или болногледачът могат да инжектират Valtropin след обучение от лекар или сестра.
The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
За повече информация относно лечението с Valtropin, прочетете листовката (също част от този EPAR) или се обърнете към Вашия лекар или фармацевт.
For more information about treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Лекарят прецизира дозата индивидуално за всеки пациент в зависимост от телесното тегло и състоянието на пациента, като с времето може да се наложи дозата да бъде коригирана в зависимост от промяната в теглото и повлияването.
The doctor calculates the dose for each patient individually, depending on the body weight and condition, and may need to adjust it over time, depending on changes in body weight and response.
Това означава, че Valtropin е подобен на биологично лекарство („референтно лекарство“), което вече е одобрено за употреба в Европейския съюз (ЕС), и че Valtropin и референтното лекарство съдържат едно и също активно вещество.
This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Valtropin.
This is a summary of the European public assessment report (EPAR) for Valtropin.
Поради това СНМР счита, че както при Humatrope, ползите превишават установените рискове.
Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Той стимулира растежа по време на детството и юношеството и въздейства върху начина, по който организмът преработва белтъци, мазнини и въглехидрати.
It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Valtropin е сравнен с Humatrope при 149 деца с недостиг на растежен хормон, които не са лекувани преди това.
Valtropin was compared with Humatrope in 149 children with a lack of growth hormone and who had not been treated before.
Valtropin замества естествения хормон.
Valtropin replaces the natural hormone.
Това се приема за достатъчно, за да се демонстрира, че ползите от Valtropin са сравними с ползите от референтното лекарство.
This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
СНМР решава, че съгласно изискванията на ЕС Valtropin е показал сравними с Humatrope качество, безопасност и ефикасност.
The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Мястото на инжектиране трябва да се сменя, за да се избегне липодистрофия (загуба на мастна тъкан под кожата).
The site of injection must be varied to avoid lipoatrophy (loss of fat below the skin).
Valtropin се използва също за лечение на възрастни с изразен недостиг на растежен хормон, като заболяването е с начало в зряла или детска възраст и трябва да бъде потвърдено с изследване преди лечението (заместващо лечение).
Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).
ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Valtropin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
В него се разяснява оценката на Комитета по лекарствените продукти за хуманна употреба (CHMP) относно лекарството, на която Комитетът основава становище за издаване на разрешение за употреба и препоръки относно условията на употреба за Valtropin.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Valtropin.
Valtropin не трябва да се прилага в случаите, когато пациентът има активен тумор или животозастрашаващо заболяване.
Valtropin must not be used when the patient suffers from an active tumour, or a life-threatening illness.
Активното вещество във Valtropin, соматропин, е идентично на човешкия хормон на растежа.
The active substance in Valtropin, somatropin, is identical to human growth hormone.
деца с нисък ръст поради синдром на Търнър (рядко генетично заболяване, засягащо момичета), доказан чрез хромозомен анализ (изследване на ДНК);
• children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Най-честите нежелани реакции при Valtropin са реакции в мястото на инжектиране и хормонални промени, а при възрастни - главоболие, парестезия (необикновени усещания като иглички и изтръпване), артралгия (болки в ставите) и ставни увреждания.
The most common side effects with Valtropin are reactions at the site of injection and hormonal changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia (joint pain) and joint disorders.
Valtropin се прилага чрез подкожна инжекция веднъж дневно.
Valtropin is given by injection under the skin, once a day.
Valtropin не трябва да се прилага за стимулиране на растежа при деца със затворени епифизи (състояние, при което дългите кости са приключили растежа си).
Valtropin must not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Лечението с Valtropin трябва да бъде проследявано от лекар с опит в лечението на пациенти с нарушения в растежа.
Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Той се произвежда по метод, познат като „рекомбинантна ДНК технология“: от дрожди, получили ген (ДНК), който ги прави способни да синтезират соматропин.
It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Valtropin е противопоказан за хора, които биха могли да проявят свръхчувствителност (алергични реакции) към соматропин или някоя от другите съставки (разтворителят на Valtropin съдържа метакрезол).
Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the solvent for Valtropin contains metacresol).
Референтното лекарство за Valtropin е Humatrope.
The reference medicine for Valtropin is Humatrope.
Допълнителна информация за Valtropin:
Other information about Valtropin
Valtropin е „биоподобно“ лекарство.
Valtropin is a ‘biosimilar' medicine.
Valtropin съдържа активното вещество соматропин (somatropin).
Valtropin contains the active substance somatropin.
Valtropin е проучен с цел да се покаже, че е сравним с референтното лекарство Humatrope.
Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
деца над две години и юноши със забавен растеж поради недостатъчна секреция на растежен хормон (заместващо лечение);
• children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Какви ползи от Valtropin са установени в проучванията?
What benefit has Valtropin shown during the studies?
Какви са рисковете, свързани с Valtropin?
What is the risk associated with Valtropin?
Хормонът на растежа се секретира от жлеза, наречена хипофиза, намираща се в основата на мозъка.
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Valtropin е прах и разтворител, от които се приготвя инжекционен разтвор.
Valtropin is a powder and solvent that are made up into a solution for injection.
За пълния списък на всички наблюдавани при Valtropin нежелани реакции - вижте листовката.
For the full list of all side effects reported with Valtropin, see the package leaflet.
Как е проучен Valtropin?
How has Valtropin been studied?
деца в предпубертета със забавен растеж поради хронично бъбречно заболяване (хронична бъбречна недостатъчност).
• children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
За какво се използва Valtropin?
What is Valtropin used for?
Какво представлява Valtropin?
What is Valtropin?
Как действа Valtropin?
How does Valtropin work?
Какви са основанията за одобряване на Valtropin?
Why has Valtropin been approved?
Как да използвате Valtropin?
How is Valtropin used?
Vielleicht möchten Sie diese später nochmals lesen.
You may need to read it again.
Inhalt (Konzentration)
Content (concentration)
sind gewöhnlich gering und asymptomatisch.
These are usually slight and asymptomatic.
Es ist daher wichtig, dass Sie den Rat in Abschnitt 3.
Therefore, it is important that you follow the advice given in section 3.
2 Jahre
2 years
Es ist hilfreich, wenn Sie notieren, welche Beschwerden bei Ihnen aufgetreten sind, wann sie begannen und wie lange
It will help if you make a note of what you experienced, when it started and how long it lasted.
Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.
Not all pack sizes may be marketed.
- Nicht mit Kaffee oder Tee einnehmen.
- Do not take with coffee or tea.
Die Proteinbindung in Humanplasma beträgt etwa 78 %.
Protein binding in human plasma is approximately 78%.
GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter den folgenden Bezeichnungen zugelassen:
This medicinal product is authorised in the Member States of the EEA under the following names:>
Die Relevanz dieser Beobachtung für den Menschen ist nicht bekannt.
The relevance for humans is unknown.
Es kann anderen Menschen schaden, auch wenn diese dieselben Symptome haben wie Sie.
It may harm them, even if their symptoms are the same as yours.
Wie Muskeln benötigen auch Knochen Bewegung, um stark und gesund zu bleiben.
Like muscles, bones need exercise to stay strong and healthy.
Sprechen Sie zuerst mit Ihrem Arzt und folgen Sie seinem Rat.
Talk to your doctor first and follow the advice given.
ATC-Code: M05B A04
ATC code: M05BA04
6.2 Inkompatibilitäten
6.2 Incompatibilities
Nicht über 25 °C lagern.
Do not store above 25 °C.
Diese Gebrauchsinformation wurde zuletzt genehmigt im { MM/JJJJ }
This leaflet was last approved in {MM/YYYY}.
WISSENSCHAFTLICHE SCHLUSSFOLGERUNGEN
SCIENTIFIC CONCLUSIONS
Wenden Sie sich an Ihren Arzt, bevor Sie mit einem Übungsprogramm beginnen.
Consult your doctor before you begin any exercise programme.
Der Zeitpunkt des Auftretens dieser Symptome variierte von einem Tag bis zu mehreren Monaten nach Therapiebeginn.
The time to onset of symptoms varied from one day to several months after starting treatment.
Ein Kausalzusammenhang kann nicht ausgeschlossen werden (siehe Abschnitt 4.8).
A causal relationship cannot be excluded (see section 4.8).
- Nicht mit Saft oder Milch einnehmen.
- Do not take with juice or milk.
Die Inzidenz neuer Wirbelfrakturen wurde als Sicherheitsvariable evaluiert.
The incidence of new vertebral fractures was evaluated as a safety variable.
- Unfähigkeit, für mindestens 30 Minuten zu stehen oder aufrecht zu sitzen.
• Inability to stand or sit upright for at least 30 minutes.
Viele dieser Patienten erhielten auch eine Chemotherapie und Kortikosteroide.
Many of these patients were also receiving chemotherapy and corticosteroids.
Anwendung bei Kindern
Use in children
4.5 Wechselwirkungen mit anderen Arzneimitteln und sonstige Wechselwirkungen
4.5 Interaction with other medicinal products and other forms of interaction
2) Sie dürfen die Tablette nicht kauen oder im Mund zergehen lassen.
2) Do not chew the tablet or allow it to dissolve in your mouth.
Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme dieses Arzneimittels beginnen.
Read all of this leaflet carefully before you start taking this medicine.
*) Siehe Abschnitt 4.4 und 4.2
*See section 4.2 and 4.4.
hat der CHMP die folgende Indikation empfohlen, die der Leitlinie zur Beurteilung von Arzneimitteln für die Behandlung primärer Osteoporose (CHMP/EWP/552/95 Rev.2) entspricht:
The CHMP has recommended the following indication, which is in accordance with the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CHMP/EWP/552/95 Rev.2)
Alendronat HEXAL wird nicht empfohlen für die Anwendung bei Kindern aufgrund des Fehlens von Daten zur Unbedenklichkeit und Wirksamkeit.
Alendronate HEXAL is not recommended for use in children due to a lack of data on safety and efficacy.
Sehr selten: < 1/10,000, nicht bekannt (auf Grundlage der verfügbaren Daten nicht abschätzbar)
Very rare: < 1/10,000, not known (cannot be estimated from the available data)
- Hypokalzämie.
• Hypocalcaemia.
ETIKETTIERUNG
LABELLING
sich auf den letzten Tag des Monats.
The expiry date refers to the last day of that month.
Diese tritt sowohl bei Männern als auch bei Frauen aller Altersstufen auf. Die Wirksamkeit von einmal
This occurs in both men and women of all ages.
Zusätzlich zu Ihrer Behandlung mit Alendronate HEXAL kann Ihr Arzt Ihnen Vorschläge zu Veränderungen Ihrer Lebensweise machen, die Ihren Zustand verbessern könnten, wie:
As well as your treatment with Alendronate HEXAL, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Diese Nebenwirkungen können
POSSIBLE SIDE EFFECTS
4.7 Auswirkungen auf die Verkehrstüchtigkeit und die Fähigkeit zum Bedienen von Maschinen
4.7 Effects on ability to drive and use machines
4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung
4.4 Special warnings and precautions for use
Wenn Sie weitere Fragen zur Anwendung des Arzneimittels haben, fragen Sie Ihren Arzt oder Apotheker.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Unter der Behandlung mit Alendronat gebildeter Knochen ist von normaler Qualität.
Bone formed during treatment with alendronate is of normal quality.
Packungen mit 14, 28, 56, 98, 112 und 50 x 1 (Einzeldosen).
14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Es ist sehr wichtig, dass die Patienten vollständige Anweisungen zur Einnahme erhalten und diese verstehen (siehe Abschnitt 4.2).
It is very important that complete administration instructions are given to, and understood, by the patient (see section 4.2).
sollte daher aufmerksam auf alle Anzeichen oder Symptome einer möglichen Reaktion am Ösophagus achten.
The physician should therefore be alert to any signs or symptoms of possible oesophageal reaction.
Während der Behandlung sollten bei diesen Patienten invasive zahnärztliche Eingriffe möglichst vermieden werden.
While on treatment, these patients should avoid invasive dental procedures if possible.
50 x 1 (Einzeldosen) tablet
50 x 1 (unit dose) tablet
Hautausschlag mit Photosensitivität.
Skin rash with photosensitivity.
- Nicht mit Mineralwasser (mit oder ohne Kohlensäure) einnehmen.
- Do not take with mineral water (still or sparkling).
Die Plasmakonzentrationen fielen nach intravenöser Verabreichung innerhalb von 6 Stunden um über 95 % ab.
Plasma concentrations fell by more than 95% within 6 hours following intravenous administration.
GEGEBENENFALLS BESONDERE VORSICHTSMASSNAHMEN FÜR DIE BESEITIGUNG VON NICHT VERWENDETEM ARZNEIMITTEL ODER DAVON STAMMENDEN ABFALLMATERIALIEN
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Nicht zutreffend.
Not applicable.
Bitte informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen/anwenden bzw. vor kurzem eingenommen/angewendet haben, auch wenn es sich um nicht verschreibungspflichtige Arzneimittel handelt.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Wegen des Risikos einer Ösophagusreizung sollte kein Erbrechen induziert werden und der Patient sollte in aufrechter Position bleiben.
On account of the risk of oesophageal irritation, vomiting should not be induced and the patient should be kept in an upright position.
Zudem wurde eine statistisch signifikante Abnahme der Inzidenz von Hüftfrakturen festgestellt (1,1 % versus 2,2 %, Abnahme um 51 %).
In addition, a statistically significant reduction in the incidence of hip fractures was confirmed (1.1 % versus 2.2 %, a reduction of 51 %).
Spezifische Informationen im Hinblick auf eine Überdosierung mit Alendronat liegen nicht vor.
There is no specific information available with regard to overdosage with alendronate.
Weiterhin werden Krebs, Chemotherapie, Radiotherapie, Kortikosteroide und schlechte Mundhygiene als Risikofaktoren erachtet (siehe Abschnitt 4.4).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Deshalb ist bei älteren Patienten eine Dosisanpassung nicht notwendig.
Therefore no adjustment of the dose is necessary for elderly patients.
Die Wirkungen von Alendronat auf die BMD und die Frakturinzidenz bei postmenopausalen Frauen wurden in zwei ersten Wirksamkeitsstudien mit identischem Design (n = 994) und im Fracture Intervention Trial (FIT: n = 6459) untersucht.
The effects of alendronate on BMD and fracture incidence in post-menopausal women were studied in two initial efficacy studies of identical design (n=994), and in the Fracture Intervention Trial (FIT: n=6459).
Im Hinblick auf die Indikation sollte Alendronat während der Schwangerschaft nicht angewendet werden.
In view of the indication, alendronate should not be used during pregnancy.
Weitere Informationen
FURTHER INFORMATION
Alendronsäure gehört zu einer Gruppe von nicht hormonellen Arzneimitteln, den so genannten Bisphosphonaten.
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Erkrankungen des Ohrs und des Labyrinths: Vertigo
Ear and labyrinth disorders: vertigo
KOMPLETTE ZUSAMMENFASSUNG DER WISSENSCHAFTLICHEN BEURTEILUNG VON ALENDRONAT HEXAL UND DAMIT VERBUNDENEN BEZEICHNUNGEN (siehe Anhang I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ALENDRONATE HEXAL AND ASSOCIATED NAMES (see Annex I)
Bei den Patienten, die Alendronat in Dosen bis zu 10 mg täglich erhielten und bei denen nach einem Jahr eine Biopsie durchgeführt wurde, wurden keine Anzeichen für eine Störung der Knochenmineralisation festgestellt.
In the patients who received alendronate in doses up to 10 mg daily and in whom biopsy was performed after one year no signs of a disturbance of the bone mineralisation process were seen.
Nach einer intravenösen Einzeldosis von 10 mg betrug die renale Clearance von Alendronat 71 ml/min und die systemische Clearance lag nicht über 200 ml/min.
Following a single intravenous dose of 10 mg, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min.
4.6 Schwangerschaft und Stillzeit
4.6 Pregnancy and lactation
Merkmale bei Patienten
Characteristics in patients
Die Osteoklastenaktivität wird gehemmt, während die Bildung und Bindung der Osteoklasten nicht beeinträchtigt wird.
Osteoclastic activity is inhibited, but formation and binding of the osteoclasts is not affected.
Nach Markteinführung wurden folgende Reaktionen berichtet (Häufigkeit unbekannt):
During post-marketing experience the following reactions have been reported (frequency unknown):
• FIT 1: Drei-Jahres-Studie bei 2027 Patientinnen mit mindestens einer vorbestehenden Wirbelfraktur (Kompressionsfraktur).
• FIT 1: A three-year study with 2027 patients who had had at least one baseline vertebral (compression) fracture.
Pharmakotherapeutische Gruppe: Arzneimittel zur Behandlung von Knochenerkrankungen, Bisphosphonate
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates.
Die Einnahme von Alendronat zusammen mit Kaffee oder Orangensaft reduzierte die Bioverfügbarkeit um etwa 60 %.
Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approx. 60 %.
Die terminale Halbwertszeit beim Menschen wird wegen der Freisetzung von Alendronat aus dem Skelett auf über zehn Jahre geschätzt.
The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Die Patienten müssen daher nach der Einnahme von Alendronat mindestens 30 Minuten warten, bis sie andere orale Arzneimittel einnehmen (siehe Abschnitt 4.2).
Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
Alendronate HEXAL ist nicht für Kinder und Jugendliche geeignet.
Alendronate HEXAL should not be given to children and adolescents.
VERZEICHNIS DER BEZEICHNUNGEN, DARREICHUNGSFORM, STÄRKE, ART DER ANWENDUNG DES ARZNEIMITTELS, DES ANTRAGSTELLERS, DES INHABERS DER GENEHMIGUNG FÜR DAS INVERKEHRBRINGEN IN DEN MITGLIEDSTAATEN
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Antragsteller Phantasiebezeichnung Name
Invented name Name
Die Brüche entstehen gewöhnlich an der Hüfte, Wirbelsäule oder am Handgelenk und können nicht nur Schmerzen, sondern auch erhebliche Probleme wie gebeugte Körperhaltung („Witwenbuckel“) und Verlust der Beweglichkeit verursachen.
Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager's hump') and loss of mobility.
MINDESTANGABEN AUF BLISTERPACKUNGEN PVC/PE/PVDC/AL
MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/PE/PVDC/AL
Andere Getränke (einschließlich Mineralwasser), Nahrungsmittel und einige Arzneimittel können möglicherweise die Resorption von Alendronat verringern (siehe Abschnitt 4.5).
Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5).
WELCHE NEBENWIRKUNGEN SIND MÖGLICH? Wie alle Arzneimittel kann Alendronate HEXAL Nebenwirkungen haben, die aber nicht bei jedem auftreten müssen.
Like all medicines, Alendronate HEXAL can have side effects, although not everybody gets them.
Vorübergehende Symptome wie bei einer Akute-Phase-Reaktion (Myalgie, Unwohlsein und in seltenen Fällen Fieber) meist bei Einleitung der Behandlung.
Transient symptoms as in an acute phase reaction (myalgia, malaise and in rare cases fever) usually in connection with the start of treatment.
Wichtige Informationen über bestimmte sonstige Bestandteile von Alendronate HEXAL Alendronate HEXAL enthält Lactose.
Important information about some of the ingredients of Alendronate HEXAL Alendronate HEXAL contains lactose.