Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALBUMIN HUMAN
GERMAX SDN. BHD.
ALBUMIN HUMAN
50ml mL
BIO PRODUCTS LABORATORY LIMITED
ZENALB@ 20 (20 _%_ human albumin solution) ABL23 This leaflet is a summary ot information available about your medicine. Please read ft carefully and ft anything is unclear or you want to know more, ask your doctor. ~~~Tc~t~~~; aMs~~~?~Nv~';:"'~:' ~~~::.:;:\~~~:r.,~ '::'~~"~~'a:J~i~~~:nr:~~~s _I;:,~~:_ ~~c~,,~:~ ~ft':, ~~~ or l00ml of liGuid. There IS also a plastic sling in the pack which is used to hang up Ihe bonle when you are being given the medicine. The product is for Intravenous inlusion Ian injection given slowly into a vein) and is only available on a docto~s orescnDlion Your medicine has been made frDm blood plasma from screened donors. These donors are selected from the USA. tt contains proteins, which are substances lhat occur naturally in your bocIy and are needed for many difterent functions. The steritised liquid in the glass bottle contains ~~~r;:t~e~sp~n;~~ro~;~J~~~~~~eige~: :~~ ~\p~~a~o/b~fa~g~r:;:~Jth1't,:ct~':t~;~~~)c~~~:~ ~~m~~~%~: potassium cilrate, and may also confain a very small quantfty of aluminium which dissolves out of the glass bottle. Zenalb' 20 does not contain any preservatives. Other substances, such as the factors that help blood clot and those that detenmine a person's blood group, have been taken out because they can cause certain side-effects. WHO MAKES ZENALBo 2O? Your medicine is made by the product licence holder BPL, Bio Products Laboratory, Dagger Lane, Eistree, Herts. WD63BX. PL 08801/0007. WHAT IS YOUR MEDICINE USED FOR? " is very important Ihat the right amount of fluid is circulating in your blood stream. II you lose a lot 01 fluid, you will need to have extra tluid put back inlo your body to replace iI. Zenalb" 20 has four times the amount of albumin and twice the amount of protein as plasma. This medicine is also suitable for premature babies and patienls on kidney dialysis (blood "cleaning" by a machine) as ft conlains only very small quantilies of aluminium. WHEN SHOULD YOU NOT USE THIS MEDICINE? Tell your doclor " you: . have ever had to stop taking this or a Կարդացեք ամբողջական փաստաթուղթը
GPS Limited Tel: 020 8863 9700 Job No: 18547 Text Sizes: Main Body Text 6pt Line Spacing 7pt Fonts used: Helvetica Neue 55 Roman 75 Bold Project Name: Zenalb 20 PIL Malaysia ABMY5 Contact: Laura Ambrose Client Order No. P53744 Date: 26/06/2020 Proof No. 5 Operator: Hema Joshi Doc. Size: 170 x 220mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB 20 HUMAN ALBUMIN 20% SOLUTION ABMY5 COLOURS: PANTONE PROCESS BLACK 1. NAME OF THE MEDICINAL PRODUCT Zenalb 20, Human Albumin 200 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zenalb 20 is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A vial of 100 ml contains 20 g of human albumin. Zenalb 20 has a mildly hyperoncotic effect. Excipient with known effect: Zenalb 20 contains approximately 50-120 mmol/l sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid, it is almost colourless, yellow, amber or green. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zenalb 20 is indicated in all patients for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient’s individual requirements. POSOLOGY The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: – arterial blood pressure and pulse rate – central venous pressure – pulmonary artery wedge pressure – urine output – electrolyte – haematocrit/haemoglobin METHOD OF ADMINISTRATION Human albumin can be directly administered by the Կարդացեք ամբողջական փաստաթուղթը