MARCAIN HEAVY Solution for injection (2017)
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Περιεχόμενα
1. Name of the medicinal product
Marcain Heavy, 0.5% solution for injection.
2. Qualitative and quantitative composition
Bupivacaine Hydrochloride BP 5.28 mg/ml equivalent to 5 mg/ml bupivacaine hydrochloride anhydrous. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. Clear, colourless solution.
4.1. Therapeutic indications
Marcain Heavy 0.5% solution for injection is indicated in adults and children of all ages for intrathecal (subarachnoid) spinal anaesthesia for surgery (urological and lower limb surgery lasting 2–3 hours, ...
4.2. Posology and method of administration
Posology Adults and children above 12 years of age The doses recommended below should be regarded as a guide for use in the average adult. The figures reflect the expected average dose range needed. Standard ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to local anaesthetics of the amide type. Intrathecal anaesthesia, regardless of the local anaesthetic ...
4.4. Special warnings and precautions for use
Intrathecal anaesthesia should only be undertaken by clinicians with the necessary knowledge and experience. Regional anaesthetic procedures should always be performed in a properly equipped and staffed ...
4.5. Interaction with other medicinal products and other forms of interaction
Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. certain anti-arrhythmics, such as lidocaine ...
4.6. Pregnancy and lactation
Pregnancy There is no evidence of untoward effects in human pregnancy. In large doses, there is evidence of decreased pup survival in rats and an embryological effect in rabbits if Marcain is administered ...
4.7. Effects on ability to drive and use machines
Marcain Heavy has minor influence on the ability to drive and use machines. Besides the direct anaesthetic effect, local anaesthetics may have a very mild effect on mental function and co-ordination even ...
4.8. Undesirable effects
General Tabulated list of adverse reactions The adverse reaction profile for Marcain Heavy is similar to those for other long acting local anaesthetics used for intrathecal anaesthesia. Frequencies are ...
4.9. Overdose
Marcain Heavy, used as recommended, is not likely to cause blood levels high enough to cause systemic toxicity. However, if other local anaesthetics are concomitantly administered, toxic effects are additive ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group (ATC code):</b> N01BB01 Bupivacaine is a long acting local anaesthetic agent of the amide type. Moderate muscular relaxation of lower extremities. Motor blockade of the abdominal ...
5.2. Pharmacokinetic properties
Rapid onset of action and long duration i.e. T<sub>10</sub>–T<sub>12</sub> segments – duration 2–3 hours. Muscular relaxation of lower extremities lasts 2–2.5 hours. Blockade of the abdominal muscles lasts ...
5.3. Preclinical safety data
Bupivacaine hydrochloride is a well-established active ingredient.
6.1. List of excipients
Glucose anhydrous and/or glucose monohydrate Sodium hydroxide Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
4 ml sterile wrapped glass ampoules or One Point Cut ampoules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
The solution should be used immediately after opening of the ampoule. Any remaining solution should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with ...
7. Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PL 39699/0077
9. Date of first authorization / renewal of the authorization
20/09/2004
10. Date of revision of the text
August 2017
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