HUMAN TETANUS IMMUNOGLOBULIN Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Human Tetanus Immunoglobulin, 100 IU/ml sterile solution.
Qualitative and quantitative composition
Human tetanus immunoglobulin. Human protein content: 40-180 g/l, of which at least 95% is IgG. Each vial contains nominally 250 IU of human tetanus immunoglobulin. One ml contains at least 100 IU of human ...
Pharmaceutical form
Solution for injection. Clear or slightly opalescent, colourless or pale yellow sterile solution.
Therapeutic indications
Post-exposure prophylaxis Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with ...
Posology and method of administration
Posology Prophylaxis of tetanus prone wounds: 250 IU, unless the risk is thought to be extremely high the dose may be increased to 500 IU in:infected wounds, where surgically appropriate treatment cannot ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA. ...
Special warnings and precautions for use
Ensure that Human Tetanus Immunoglobulin is not administered into a blood vessel, because of the risk of shock. Hypersensitivity True hypersensitivity reactions are rare but allergic-type responses to ...
Interaction with other medicinal products and other forms of interaction
Live attenuated virus vaccines Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps and varicella, for a period ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects ...
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
Undesirable effects
Summary of the safety profile Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. ...
Overdose
Consequences of an overdose are not known.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immune sera and immunoglobulins: human tetanus immunoglobulin <b>ATC code:</b> J06BB02 Human tetanus immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically ...
Pharmacokinetic properties
Absorption and distribution Human tetanus immunoglobulin for intramuscular use is bioavailable in the recipients circulation after a delay of 2-3 days. Human tetanus immunoglobulin has a half-life of about ...
Preclinical safety data
Human Tetanus Immunoglobulin is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed ...
List of excipients
Sodium chloride Glycine Sodium acetate trihydrate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the medicinal product should be used immediately. If not used immediately, in-use ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Storage for up to one week at room temperature (up to 25°C) in the unopened package is not detrimental. Do not freeze. Keep the vial in the outer carton in order to ...
Nature and contents of container
Vials are for single use only. 5 ml glass vial (Type I Ph.Eur.) with stopper (halobutyl rubber), with an overseal (aluminium) and tamper-evident cap (polypropylene).
Special precautions for disposal and other handling
This medicinal product should be brought to room or body temperature before use. The colour can vary from colourless to pale-yellow and is either clear or slightly opalescent. Do not use solutions that ...
Marketing authorization holder
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
Marketing authorization number(s)
PL 08801/0011
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 June 1991
Date of revision of the text
April 2022
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