CURAM Powder for oral suspension / Film-coated tablet (2022)

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

Περιεχόμενα

1. Name of the medicinal product

Curam Powder for oral suspension. Curam Film coated tablet. Curam Duo 500/125 Film coated tablet.

2. Qualitative and quantitative composition

Curam tablet 250 + 125 mg: Each tablet contains Amoxicillin Trihydrate Ph. Eur. equivalent to amoxicillin 250 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg. Curam Duo ...

3. Pharmaceutical form

Curam tablet: Tablet, film-coated, oblong biconvex formed, off-white colour, scored on both sides. Curam Duo 500/125 tablet: Tablet, film-coated, oval biconvex formed, off-white colour, scored ...

4.1. Therapeutic indications

Short-term treatment of common bacterial infections such as: Upper respiratory tract infections (including ENT): e.g. tonsillitis, sinusitis, otitis media Lower respiratory tract infections: ...

4.2. Posology and method of administration

Dosage Premature No dosage recommendations can be made for this category. Children 3 to 9 months 1.25 mL of Curam oral suspension 125 + 31.25 mg/5 mL three times a day. Children 9 months to 2 years 2.5 ...

4.3. Contraindications

Hypersensitivity to one of the constituents of the medicine. In patients with a history of hypersensitivity to other beta-lactams such as penicillins, cephalosporins, carbapenems or monobactams. Curam ...

4.4. Special warnings and precautions for use

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Serious and ...

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with amoxicillin/clavulanic acid may result in increased and prolonged ...

4.6. Fertility, pregnancy and lactation

Effects on fertility There are no data on the effects of amoxicillin trihydrate/potassium clavulanate on fertility in humans. Reproduction studies in animals (mice and rats at doses up to 10 times the ...

4.7. Effects on ability to drive and use machines

This medicine is presumed to be safe or unlikely to produce an effect. Adverse effects on the ability to drive or operate machinery have not been observed.

4.8. Undesirable effects

Data from large clinical trials were used to determine the frequency of very common to rare adverse effects. The incidences of all other adverse effects occurring below 1 in 10,000 were mainly determined ...

4.9. Overdose

Drug dependency, addiction and recreational abuse have not been reported as problems. Signs and symptoms Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident. Complications ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: J01CR02 – Combinations of penicillins, including beta-lactamase inhibitors. Antibiotic class: Semi-synthetic penicillin compounded with a beta-lactamase inhibitor. ...

5.2. Pharmacokinetic properties

Absorption Amoxicillin and clavulanic acid are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of ...

5.3. Preclinical safety data

Genotoxicity No data available. Carcinogenicity No data available.

6.1. List of excipients

Curam tablet: Microcrystalline cellulose, croscarmellose sodium, talc, povidone, magnesium stearate, titanium dioxide, hypromellose, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, triethyl ...

6.2. Incompatibilities

None known.

6.3. Shelf life

Unopened container: Curam tablets: 36 months. Curam powder for oral suspension: 36 months. After container first opened: Not applicable. After dilution or reconstitution: Curam tablets: ...

6.4. Special precautions for storage

Store below 25°C. Protect from moisture.

6.5. Nature and contents of container

Curam tablet: Blisters of 15, 21 and 100 tablets. Curam Duo 500/125 tablet: Blisters of 10, 15, 21, 50, 80 and 100 tablets. Curam powder for oral suspension: Bottles of 60 and 100 ...

6.6. Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements. Curam powder for oral suspension reconstitution instructions Curam powder for oral suspension 125 mg/5 ...

7. Marketing authorization holder

Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149 Telephone: 0800 354 335

9. Date of first authorization / renewal of the authorization

Date of first approval: 21 August 2016

10. Date of revision of the text

10/11/2022

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf