Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
immunoglobulin anti-D (Rh) human
CSL Behring AG
J06BB01
immunoglobulin anti-D (Rh) human
300mcg/2ml
solution for i/v and i/m injection
pre-filled syringe 2ml and needle, in blister
Prescription
Registered
2015-12-30
OBESITY There have been reports that the intramuscular administration of Rhophylac in patients with a body mass index (BMI) ³ 30 is associated with a risk of lack of efficacy. Therefore, in patients with a BMI ³ 30 intravenous administration should be considered. INFORMATION ON SAFETY WITH RESPECT TO TRANSMISSIBLE AGENTS Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). They may be of limited value against non-enveloped viruses such as hepatitis A (HAV) or parvovirus B19. There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety. It is strongly recommended that every time that Rhophylac is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. 8. 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, as the efficacy of the live virus vaccine may be impaired. If anti-D immunoglobulin needs to be administered within 2 to 4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired. I Prečítajte si celý dokument
CSL BEHRING LATAM/EEMEA RPI ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN VERSION 1.0 REVISION DATE 08-10-2015 RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG Page 1 of 14 REGIONAL PRODUCT INFORMATION (LATAM/EEMEA) ENGLISH RHOPHYLAC, 300 HUMAN ANTI-D IMMUNOGLOBULIN VERSION: 1.0 REVISION DATE: 08-10-2015 REASON FOR CHANGE: CCSI V2.0 UPDATE AND NEW RPI TEMPLATE IMPLEMENTATION Text Convention: Headers, footers and line numbers will not be printed. text: text to be adapted as appropriate, according to local requirements CSL BEHRING LATAM/EEMEA RPI ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN VERSION 1.0 REVISION DATE 08-10-2015 RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG Page 2 of 14 CSL BEHRING 1 2 1. NAME OF THE MEDICINAL PRODUCT 3 Rhophylac 300 4 5 6 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 7 8 _a._ _ _ _Active substance _ 9 Human Anti-D immunoglobulin*. 10 The product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is 11 human albumin as stabiliser. At least 95% of the other plasma proteins are IgG. Distribution of the 12 IgG subclasses (approximate values): IgG1 84.1 %, IgG2 7.6 %, IgG3 8.1 %, IgG4 1.0 %. 13 Rhophylac contains not more than 5 micrograms/ml IgA. 14 15 *Produced from the plasma of human donors. 16 17 18 _b._ _ _ _Excipients _ 19 Human albumin 10 mg/ml 20 Glycine 20.6 mg/ml 21 Sodium chloride ≤ 250 mmol/l 22 23 Rhophylac contains no preservatives. 24 25 3. PHARMACEUTICAL FORM AND UNIT CONTENT OF ACTIVE INGREDIENT 26 Solution for intravenous or intramuscular injection in a pre-filled syringe. 27 Each 2 ml solution in a pre-filled syringe contains: 28 Human anti-D immunoglobulin G (IgG) 1,500 IU (300 micrograms) corresponding to a 29 concentration of 750 IU (150 micrograms) per ml. 30 CSL BEHRING LATAM/EEMEA RPI ROPHYLAC, 300: HUMAN ANTI-D IMMUNOGLOBULIN VERSION 1.0 REVISION DATE 08-10-2015 RHOPHYLAC 300 MICROGRAMS / 2 ML, CSL Behring AG Page 3 of 14 31 Rhophylac is a clear, colourless to pale yellow immunoglobulin solution. 32 The solution is slightly hypertonic. Rhophy Prečítajte si celý dokument