BISOCOR Tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Bisocor 5 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 5 mg of bisoprolol fumarate. <u>Excipient with known effect:</u> Lactose Monohydrate 136 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. The tablets are pale yellow mottled in colour, round and convex with the following identification markings: BI centrally above a break-line with 5 below. The tablets can be divided into equal halves. ...
4.1. Therapeutic indications
Hypertension. Chronic stable angina pectoris.
4.2. Posology and method of administration
Posology The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients, 5 mg per day may be adequate. The usual dose is 10 mg once daily with a ...
4.3. Contraindications
Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy. Cardiogenic shock. Second or third degree AV block (without a pacemaker). Sick sinus syndrome. ...
4.4. Special warnings and precautions for use
Warnings Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening ...
4.5. Interaction with other medicinal products and other forms of interaction
Combinations not recommended Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type Negative effect on contractility and atrio-ventricular conduction. Intravenous administration ...
4.6. Pregnancy and lactation
Pregnancy Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, β-adrenoceptor blocking agents reduce placental perfusion, which has been ...
4.7. Effects on ability to drive and use machines
In a study with coronary heart disease patients, bisoprolol did not impair driving performance. However, depending on the individual patients response to treatment an effect on the ability to drive a vehicleor ...
4.8. Undesirable effects
System Order<br />Class Very common<br />(>1/10) Common<br />(>1/100, <1/10) Uncommon<br />(>1/1,000 to <1/100) Rare<br />(>1/10,000 to <1/1,000) Very Rare<br />(<1/10,000) <b>Psychiatric<br />disorders ...
4.9. Overdose
The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. There is limited experience with overdose of bisoprolol, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta blocking agents, selective <b>ATC Code:</b> C07AB07 Mechanism of action Bisoprolol fumarate is a highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic ...
5.2. Pharmacokinetic properties
Absorption Bisoprolol is absorbed almost completely from the gastrointestinal tract. Together with the very small first pass effect in the liver, this results in a high bioavailability of approximately ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenicity. Like other β-blocking agents, bisoprolol ...
6.1. List of excipients
Lactose monohydrate Cellulose, microcrystalline E460 Magnesium stearate E572 Crospovidone E1201 Yellow PB 22812 (lactose monohydrate and iron oxide yellow (E172))
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
<u>Bisocor 5 mg tablets are presented in:</u> Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box. Each carton will contain either; 10, 20, 28, 30, 50, 56, 60, or 100 ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Unichem Laboratories Ltd, Studio 8B, Ard Gaoithe Commercial Centre, Ard Gaoithe Business Park, Cashel Road, Clonmel, Co Tipperary, Ireland
8. Marketing authorization number(s)
PA22654/003/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29 June 2001 Date of last renewal: 05 September 2010
10. Date of revision of the text
May 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
