RHOPHYLAC Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rhophylac 300 micrograms/2 ml, solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 300 micrograms (1500 IU) human anti-D immunoglobulin*. One ml contains 150 micrograms (750 IU) human anti-D immunoglobulin. The product contains a maximum of 30 mg/ml of ...
Pharmaceutical form
Solution for injection. The solution is clear or slightly opalescent and colourless or pale yellow. Rhophylac has an osmolality of at least 240 mosmol/kg.
Therapeutic indications
Prevention of Rh(D) isoimmunisation in Rh(D) negative women Antepartum prophylaxis:Planned antepartum prophylaxis Antepartum prophylaxis following complications of pregnancy including: Abortion/threatened ...
Posology and method of administration
Posology The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells (RBCs) and based on the knowledge that 0.5 ml of packed Rh(D) positive ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients of Rhophylac listed in section 6.1. Hypersensitivity to human immunoglobulins. The intramuscular route is contraindicated in persons ...
Special warnings and precautions for use
In the case of postpartum use, anti-D immunoglobulin is intended for maternal administration. It should not be given to the new-born infant. The product is neither intended for use in Rh(D) positive individuals, ...
Interaction with other medicinal products and other forms of interaction
Live attenuated virus vaccines Active immunisation with live virus vaccines (e.g. measles, mumps, rubella or varicella) should be postponed until 3 months after the last administration of anti-D immunoglobulin, ...
Fertility, pregnancy and lactation
Fertility No animal fertility studies have been conducted with Rhophylac. Nevertheless, clinical experience with human anti-D immunoglobulin suggests that no harmful effects on fertility are to be expected. ...
Effects on ability to drive and use machines
Rhophylac has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most serious adverse reactions observed during the treatment are hypersensitivity or allergic reactions which may in rare cases progress to a sudden fall in blood pressure ...
Overdose
No data are available on overdosage. Consequences of an overdose are not known.
Pharmacodynamic properties
Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin ATC Code: J06BB01 Mechanism of action Rhophylac contains specific antibodies (IgG) against the Rh(D) antigen of human ...
Pharmacokinetic properties
Absorption and Distribution The bioavailability of human anti-D immunoglobulin for intravenous use is complete and immediate. IgG is quickly distributed between plasma and extravascular fluid. Human anti-D ...
Preclinical safety data
Due to induction of and interference with antibodies, there are limited preclinical data of relevance for anti-D immunoglobulin. Repeated dose testing and embryo-foetal toxicity studies have not been conducted ...
List of excipients
Human albumin Glycine Sodium chloride Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (+2°C to +8°C). Do not freeze. The product must not be used after the expiry date (EXP) printed on the outer carton. Keep the syringe originally blistered in the outer carton in ...
Nature and contents of container
2 ml solution in a pre-filled syringe (type I glass) with 1 injection needle in a pack size of 1 or in a multi-pack consisting of 5 single packs. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Rhophylac should be brought to room temperature (25°C) before use. Rhophylac should be inspected visually for particulate matter and discolouration prior to administration. Do not use solutions which are ...
Marketing authorization holder
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
Marketing authorization number(s)
PL 15036/0019
Date of first authorization / renewal of the authorization
01 June 2006
Date of revision of the text
18 July 2019
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