RIMACTANE Capsule (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

Περιεχόμενα

1. Name of the medicinal product

Rimactane 300 mg Capsules.

2. Qualitative and quantitative composition

The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl) rifamycin SV. One capsule contains 300 mg rifampicin Ph. Eur. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsules. Opaque, two-piece, hard gelatine capsule, reddish-brown in colour, marked with NG 300.

4.1. Therapeutic indications

Rifampicin is a major drug in the management of tuberculosis (all forms) and certain opportunistic mycobacterial infections. It is effective in cases resistant to other anti-tuberculosis agents and shows ...

4.2. Posology and method of administration

For the management of tuberculosis and certain opportunistic mycobacterial infections Rifampicin must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resistant ...

4.3. Contraindications

Rifampicin is contraindicated in patients who: are hypersensitive to any of the rifamycins or to any of the excipients listed in section 6.1; have jaundice; are concurrently receiving saquinavir/ritonavir ...

4.4. Special warnings and precautions for use

Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician. Cautions should be taken in case of renal impairment if dose >600 mg/day. All tuberculosis patients ...

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

Pharmacodynamic Interactions When rifampicin is given concomitantly with the combination saquinavir/ritonavir, the potential for hepatotoxicity is increased. Therefore, concomitant use of Rifampicin with ...

4.6. Pregnancy and lactation

Pregnancy At very high doses in animals rifampicin has been shown to have teratogenic effects. There are no well controlled studies with rifampicin in pregnant women. Although rifampicin has been reported ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be estimated from available ...

4.9. Overdose

Human Experience Signs and Symptoms Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antimycobacterials, antibiotic ATC code: J04AB02 Mechanism of action Rifampicin exerts, both in vitro and in vivo bactericidal effects on Mycobacterium ...

5.2. Pharmacokinetic properties

Absorption Rifampicin is rapidly and completely absorbed. Following a single dose taken on an empty stomach (600 mg) the peak serum concentrations (approx. 10 g/ml) are observed after about 2 hours. Ingestion ...

5.3. Preclinical safety data

There is limited evidence as to the carcinogenic potential of rifampicin in animals. In female mice of a strain known to be susceptible to hepatomas, a significant increase in such tumours was observed ...

6.1. List of excipients

The capsules contain: Calcium stearate Lactose Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172) Gelatine Shellac glaze Propylene glycol (E1520) mmonium ...

6.2. Incompatibilities

None known.

6.3. Shelf life

Four years.

6.4. Special precautions for storage

Protect from moisture and heat (store below 30°C). Medicines should be kept out of reach of children.

6.5. Nature and contents of container

The capsules are opaque, two-piece, hard gelatine capsule size 1, reddish-brown in colour, marked with the monogram NG on each half and the code 300, and come in securitainers of 100 and PVC/PE/PVdC blister ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

8. Marketing authorization number(s)

PL 04520/0043

9. Date of first authorization / renewal of the authorization

1 February 2000

10. Date of revision of the text

17 October 2019

Πηγαίο έγγραφο

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

application/pdf