MEDOVENT Tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
Medovent 30 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 30mg ambroxol hydrochloride. <u>Excipient with known effect:</u> lactose. Each Medovent 30 mg tablet contains 134 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Tablets are white, flat, round, scored with 8 mm diameter. The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Medovent is indicated as secretolytic, for the treatment of acute bronchial disorders or acute episodes of chronic bronchopneumopathy or other chronic bronchopulmonary disorders associated with abnormal ...
4.2. Posology and method of administration
Medovent 30mg tablets is reserved for treatment in adults. Posology The recommended dose is 1 tablet three times a day. The therapeutic effect can be enhanced by administering 2 tablets of Medovent (60 ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Taking this drug is contraindicated if you have rare hereditary diseases that can cause an incompatibility with ...
4.4. Special warnings and precautions for use
There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated ...
4.5. Interaction with other medicinal products and other forms of interaction
There are no clinically relevant interactions reported with other drugs.
4.6. Pregnancy and lactation
Pregnancy Ambroxol hydrochloride crosses the placenta. Animal studies do not indicate direct or indirect harmful effects with regard to pregnancy, embryonal/fetal development, parturition or postnatal ...
4.7. Effects on ability to drive and use machines
There are no post-marketing data on an effect on the ability to drive or use machines. No studies on influence on the ability to drive or use machines have been performed.
4.8. Undesirable effects
Adverse reactions are classified using the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), ...
4.9. Overdose
There are no described overdosing effects in man. Based on reports of accidental overdoses or/and errors in administration, observed symptoms are similar to known side effects at recommended doses and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Mucolytics <b>ATC code:</b> R05CB06 Ambroxol hydrochloride, the active ingredient of Medovent, has been shown to increase respiratory tract secretion. It increases the ...
5.2. Pharmacokinetic properties
Absorption Ambroxol hydrochloride is rapidly and completely absorbed after oral formulations whose mechanism of transfer/release is unchanged dose dependent. Peak plasma concentrations occurred approximately ...
5.3. Preclinical safety data
Ambroxol hydrochloride has a low acute toxicity. After oral doses of 150 mg/kg/day administration (mice, 4 weeks), 50 mg/kg/day (rat, 52 and 78 weeks), 40 mg/kg/day (rabbit, 26 weeks) and 10 mg/kg/day ...
6.1. List of excipients
Lactose Microcrystalline cellulose Sodium carboxymethylcellulose Silicon dioxide Magnesium stearate
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package, in order to protect from light.
6.5. Nature and contents of container
Polyvinylchloride film-aluminium foil blisters, with a patient information leaflet in a card carton. Packs containing 20, 30, 50 and 60 tablets are available. Polyvinylchloride securitainers with a tamper ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
11437
9. Date of first authorization / renewal of the authorization
First authorization: 23/10/1987 Renewal authorization: 07/04/2010
10. Date of revision of the text
09/2017
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