Immunoglobulina umana anti-tetanus

Human immunoglobulin anti-tetanus

IMMUNOGLOBULINA UMANA NORMALI

HUMAN NORMAL IMMUNOGLOBULIN

Immunoglobulina umana anti-vaccinia.

Human immunoglobulin anti-vaccinia.

Fiż-żewġ preparazzjonijiet, aktar minn 10 milligrammi ta' immunoglobulina G kull gramma ta' prodott għandha tkun preżenti.

In both preparations, more than 10 milligrams of immunoglobulin G per gram of product shall be present.

Immunoglobulini speċifiċi umani għandhom ukoll jissodisfaw il-ħtiġijiet kif deskritti f'sezzjoni 4, Immunoglobulina umana normali.

Human specific immunoglobulins must further meet the requirements as described in section 4, Human normal immunoglobulin.

Il-prodott finali jinħareġ bħala soluzzjoni li ġo fih il-konċentrazzjoni immunoglobulina għandha tkun bejn 100 u 170 gramma kull litru.

The final product is issued as a solution in which the immunoglobulin concentration shall be between 100 and 170 grams per litre.

Il-prodott finali jinħareġ bħala soluzzjoni li ġo fih il-konċentrazzjoni immunoglobulina għandha tkun bejn 100 u 170 gramma kull litru.Identifikazzjoni

The label on the container shall give all the information shown on the model label (Annex 3).

Immunoglobulina umana normali hija preparazzjoni tal-proteini tal-plasma ppreparata minn demm uman sħiħ, li fiha jkun jinsab l-antibodies ta' adulti normali.

Human normal immunoglobulin is a preparation of the plasma proteins prepared from whole human blood, containing the antibodies of normal adults.

Immunoglobulina umana anti-tetanus għandu jkollha fiha mhux anqas minn 50 UI kull ml ta' tetanus antitoxin kif stabbilit permezz ta' test ta' newtralizzazzjoni fuq l-annimali.

Human immunoglobulin anti-tetanus shall contain not less than 50 IU per ml of tetanus antitoxin as determined by a neutralization test in animals.

Immunoglobulina umana anti-vaccinia għandu jkollha mhux anqas minn 500 UI kull ml ta' vaccinia antibody kif stabbilit permezz ta' test ta' newtralizzazzjoni fuq chorio-allantoic membranes jew f'kultura tat-tessut.

Human immunoglobulin anti-vaccinia shall contain not less than 500 IU per ml of vaccinia antibody as determined by a neutralization test on chorio-allantoic membranes or in tissue culture.

Soluzzjonijiet ta' immunoglobulina umana għandhom jinżammu f'kontenituri sterili, issiġillati sabiex jiġu esklużi mikro-organiżmi, ikunu protetti mid-dawl u maħżuna f'temperatura ta' 4 sa 6 C.

Human immunoglobulin solution must be kept in a sterile container, sealed so as to exclude microorganisms, protected from light and stored at a temperature of 4 to 6 C.

Billi biex jiġu żgurati livelli adegwati ta' immunoglobulina fid-demm, l-għoġġiela għandhom jirċievu biżżejjed kolostrum fl-ewwel sitt sigħat tal-ħajja tagħhom u kemm jista' jkun malajr wara li jitwieldu;

Whereas in order to ensure adequate immunoglobulin levels in the blood, calves should receive sufficient colostrum within the first six hours of life and as soon as possible after birth;

Immunoglobulina umana normali hija preparazzjoni tal-proteini tal-plasma ppreparata minn demm uman sħiħ, li fiha jkun jinsab l-antibodies ta'adulti normali. Tinkiseb minn plasma likwida umana miġbura flimkien minn mhux anqas minn 1000 donatur.

Dried human plasma must be kept in an atmosphere of nitrogen or in a vacuum in a sterile container sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at a temperature below 20 C.

Immunoglobulini speċifiċi umani għandhom ukoll jissodisfaw il-ħtiġijiet kif deskritti f'sezzjoni 4, Immunoglobulina umana normali.Skond il-kontenut ta'l-antibody, il-konċentrazzjoni tal-immunoglobulina tas-soluzzjoni finali għandha tvarja bejn 100 u 170 gramma kull litru.

By comparison of the solutions before and after heat treatment no evidence of significant denaturation of the proteins in solution shall have been detected as estimated by viscosity and turbidity measurements, ultracentrifugation and electrophoresis. The solution shall be substantially free from visible particles after heating at 57 C and after agitation in a mechanical shaker for six hours at this temperature.

Jekk ikun possibbli, il-mekkaniżmu ta' immunità (medjat miċ-ċellula/umorali, klassijiet lokali/ġenerali ta' immunoglobulina) li huwa inizjat wara s-somministrazzjoni tal-prodott mediċinali veterinarju immunoloġiku lill-annimali fil-mira bir-rotta ta' somministrazzjoni irrakkomandata għandu jkun speċifikat u dokumentat.

If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.

Skond il-kontenut ta' l-antibody, il-konċentrazzjoni tal-immunoglobulina tas-soluzzjoni finali għandha tvarja bejn 100 u 170 gramma kull litru.

Depending on the antibody content, the immunoglobulin concentration of the final solution may vary between 100 and 170 grams per litre.

L-immunoglobulini speċifiċi umani li ġejjin huma inklużi f'dawn il-ħtiġijiet:-Immunoglobulina umana anti-tetanus

Add water to the recommended volume; the dried preparation must be completely soluble.