STEMETIL Solution for injection (2020)
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
Stemetil 12.5 mg/ml Injection.
2. Qualitative and quantitative composition
Each 1 ml of Stemetil injection contains 12.5 mg prochlorperazine mesilate. <u>Excipients:</u> Each 1 ml of Stemetil injection contains 1 mg of sodium sulphite, 0.75 mg of sodium metabisulphite and 6 mg ...
3. Pharmaceutical form
Colourless sterile solution.
4.1. Therapeutic indications
Stemetil is a potent phenothiazine neuroleptic. <u>Uses:</u> The treatment of nausea and vomiting and in schizophrenia (particularly the chronic stage) and acute mania.
4.2. Posology and method of administration
Posology Adults Indication Dosage Treatment of nausea and vomiting 12.5 mg by deep i.m. injection followed by oral medication 6 hours later if necessary. Schizophrenia and other psychotic disorders ...
4.3. Contraindications
Known hypersensitivity to prochlorperazine or to any of the other ingredients listed in section 6.1. The use of Stemetil injection is contraindicated in children as it has been associated with dystonic ...
4.4. Special warnings and precautions for use
Stemetil should be avoided in patients with liver or renal dysfunction, Parkinsons disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided ...
4.5. Interaction with other medicinal products and other forms of interaction
Adrenaline must not be used in patients overdosed with Stemetil (see section 4.9). The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. ...
4.6. Pregnancy and lactation
Pregnancy Animal studies are insufficient with respect to reproductive toxicity. However, potential harmful effect in animals cannot be ruled out. There is inadequate evidence of safety in pregnancy. Data ...
4.7. Effects on ability to drive and use machines
Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.
4.8. Undesirable effects
Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders. <u>Immune system disorders:</u> Type I hypersensitivity reactions such as ...
4.9. Overdose
Symptoms of phenothiazine overdose include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psycholeptics; Phenothiazines with piperazine structure <b>ATC code:</b> N05AB04 Stemetil is a potent phenothiazine neuroleptic.
5.2. Pharmacokinetic properties
There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1. List of excipients
Sodium sulphite anhydrous (E221) Sodium metabisulphite powder (E223) Sodium chloride Ethanolamine Water for injections (non-sterilised)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Keep ampoules in the outer carton, in order to protect from light. Discoloured solutions should not be used.
6.5. Nature and contents of container
Stemetil injection is supplied in colourless glass ampoules in packs of 10 1 ml and 10 2 ml. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
8. Marketing authorization number(s)
PL 04425/0590
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28 February 1973 Date of latest renewal: 16 September 2002
10. Date of revision of the text
03/01/2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
