bhpardo/ema_en · Datasets at Hugging Face

english stringlengths 2 1.37k
Adults: oral CellCept should be initiated within 72 hours following transplantation.
If darbepoetin alfa is given concomitantly with any of these drugs, blood levels of these drugs should be monitored and the dosage adjusted as the haemoglobin rises.
BATCH NUMBER
6.5 Nature and contents of container
In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years.
5.3 Preclinical safety data
For a full list of excipients, see section 6.1.
These changes are interpreted as being secondary to decreased maternal body weight gain.
Pharmacotherapeutic group:
313 The carton contains a package leaflet with the full instructions for use and handling.
The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
- yellowing of your skin or the whites of your eyes (jaundice)
Pre-filled syringe (glass)
Adults and children in clinical studies were categorized into the three groups according to renal impairment: normal with Clcr greater than 80 ml/ min (n = 56), mild with Clcr equalling 50 to 80 ml/ min (n = 12), and moderate with Clcr less than 50 ml/ min (n = 2).
7 film-coated tablets. of Axura 5 mg 7 film-coated tablets of Axura 10 mg 7 film-coated tablets of Axura 15 mg 7 film-coated tablets of Axura 20 mg
Rare
Convulsions have been reported in patients receiving Aranesp.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Name and address of the manufacturer responsible for batch release
3 ml (3.5 mg/ ml)
If an adjustment is needed when switching the patients to Actraphane, it may occur with the first dose or during the first several weeks or months.
There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Keep this leaflet for future reference.
Not applicable.
Italia BRISTOL-MYERS SQUIBB S. R. L.
14.
SP Europe Rue de Stalle 73 B – 1180 Bruxelles Belgium
Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Nervous system disorders:
Benzalkonium chloride may be absorbed by soft contact lenses and is known to discolour soft contact lenses.
Treatment of patients with chemotherapy induced anaemia:
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
11.
Adults: oral CellCept should be initiated within 5 days following transplantation.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
depression (severe in 1.6%), anxiety, abnormal dreams, insomnia
Norge Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Tyskland Tlf: +49 (0)69 1503 – 1
10 Fig. d
7.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
9.
Protein binding was greater than 99.5%.
Always take Arava exactly as your doctor has told you.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
4.2 Posology and method of administration
4 pre-filled syringe
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Date to which the bottle must be withdrawn:
The full EPAR for Cerezyme can be found here.
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
Rash, urticaria
2 3 4 5 6 TIME - hour
In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference:
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Medicinal product subject to restricted medical prescription (See Annex:
14.
Read the package leaflet before use.
The incidence of withdrawal due to adverse events was 8% for BYETTA-treated patients, 3% for placebo-treated and 1% for insulin-treated patients in the long-term controlled trials (16 weeks or longer).
6.
For a full list of excipients, see section 6.1.
4.4 Special warnings and precautions for use
Solution for injection (injection) in a pre-filled pen.
Blister (PVC/ PVDC/ alu)
Nocznickiego 31 PL-01-918 Warszawa Tel: +48 22 56 98 200
Dosing should be titrated as necessary to maintain the haemoglobin target.
How to use AZOPT 4.
24 units selected
B.
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Aranesp therapy have been reported predominantly in patients with CRF treated subcutaneously.
This must be taken into consideration when prescribing to patients on a controlled sodium diet.
EU/ 1/ 07/ 392/ 001 21 tablets EU/ 1/ 07/ 392/ 002 20 tablets
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
SureClick x1 1 single use pre-filled pen This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4 4 single use pre-filled pens
EXPIRY DATE
In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans.
4.5 Interaction with other medicinal products and other forms of interaction
1 ml of suspension contains 10 mg brinzolamide.
STATEMENT OF ACTIVE SUBSTANCE(S)
The table also includes adverse reactions that occurred with an incidence ≥ 1% and with a statistically significantly higher and/ or ≥ 2X incidence among BYETTA-treated patients than insulin- or placebo-treated patients.
H-1074 Budapest Tel.: +36 1 288 6400
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding.
Lundbeck AS Postboks 361 N-1326 Lysaker Tlf: +47 91300800
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
6.5 Nature and contents of container
Race In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
4.
The primary efficacy parameter of the trial was overall survival, defined as the time from randomization to death from any cause.
Pharmacokinetics in Special Populations The population pharmacokinetics were analysed to evaluate the effects of demographic characteristics.
EU/ 1/ 97/ 046/ 016-020 EU/ 1/ 97/ 046/ 031 EU/ 1/ 97/ 046/ 034 EU/ 1/ 97/ 046/ 037
Package size
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).
Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenská republika GlaxoSmithKline Slovakia s. r. o.

Adults: oral CellCept should be initiated within 72 hours following transplantation.

If darbepoetin alfa is given concomitantly with any of these drugs, blood levels of these drugs should be monitored and the dosage adjusted as the haemoglobin rises.

BATCH NUMBER

6.5 Nature and contents of container

In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years.

5.3 Preclinical safety data

For a full list of excipients, see section 6.1.

These changes are interpreted as being secondary to decreased maternal body weight gain.

Pharmacotherapeutic group:

313 The carton contains a package leaflet with the full instructions for use and handling.

The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.

- yellowing of your skin or the whites of your eyes (jaundice)

Pre-filled syringe (glass)

Adults and children in clinical studies were categorized into the three groups according to renal impairment: normal with Clcr greater than 80 ml/ min (n = 56), mild with Clcr equalling 50 to 80 ml/ min (n = 12), and moderate with Clcr less than 50 ml/ min (n = 2).

7 film-coated tablets. of Axura 5 mg 7 film-coated tablets of Axura 10 mg 7 film-coated tablets of Axura 15 mg 7 film-coated tablets of Axura 20 mg

Rare

Convulsions have been reported in patients receiving Aranesp.

In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.

Name and address of the manufacturer responsible for batch release

3 ml (3.5 mg/ ml)

If an adjustment is needed when switching the patients to Actraphane, it may occur with the first dose or during the first several weeks or months.

There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.

Keep this leaflet for future reference.

Not applicable.

Italia BRISTOL-MYERS SQUIBB S. R. L.

14.

SP Europe Rue de Stalle 73 B – 1180 Bruxelles Belgium

Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda.

Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.

Nervous system disorders:

Benzalkonium chloride may be absorbed by soft contact lenses and is known to discolour soft contact lenses.

Treatment of patients with chemotherapy induced anaemia:

Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.

11.

Adults: oral CellCept should be initiated within 5 days following transplantation.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.

(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu

depression (severe in 1.6%), anxiety, abnormal dreams, insomnia

Norge Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Tyskland Tlf: +49 (0)69 1503 – 1

10 Fig. d

7.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

9.

Protein binding was greater than 99.5%.

Always take Arava exactly as your doctor has told you.

In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.

4.2 Posology and method of administration

4 pre-filled syringe

Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.

Alternatively, disperse the tablet in water and drink the resulting suspension.

Date to which the bottle must be withdrawn:

The full EPAR for Cerezyme can be found here.

In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.

The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.

Rash, urticaria

2 3 4 5 6 TIME - hour

In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference:

In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.

Medicinal product subject to restricted medical prescription (See Annex:

14.

Read the package leaflet before use.

The incidence of withdrawal due to adverse events was 8% for BYETTA-treated patients, 3% for placebo-treated and 1% for insulin-treated patients in the long-term controlled trials (16 weeks or longer).

6.

For a full list of excipients, see section 6.1.

4.4 Special warnings and precautions for use

Solution for injection (injection) in a pre-filled pen.

Blister (PVC/ PVDC/ alu)

Nocznickiego 31 PL-01-918 Warszawa Tel: +48 22 56 98 200

Dosing should be titrated as necessary to maintain the haemoglobin target.

How to use AZOPT 4.

24 units selected

B.

In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Aranesp therapy have been reported predominantly in patients with CRF treated subcutaneously.

This must be taken into consideration when prescribing to patients on a controlled sodium diet.

EU/ 1/ 07/ 392/ 001 21 tablets EU/ 1/ 07/ 392/ 002 20 tablets

When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.

SureClick x1 1 single use pre-filled pen This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4 4 single use pre-filled pens

EXPIRY DATE

In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans.

4.5 Interaction with other medicinal products and other forms of interaction

1 ml of suspension contains 10 mg brinzolamide.

STATEMENT OF ACTIVE SUBSTANCE(S)

The table also includes adverse reactions that occurred with an incidence ≥ 1% and with a statistically significantly higher and/ or ≥ 2X incidence among BYETTA-treated patients than insulin- or placebo-treated patients.

H-1074 Budapest Tel.: +36 1 288 6400

In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.

The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding.

Lundbeck AS Postboks 361 N-1326 Lysaker Tlf: +47 91300800

Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

6.5 Nature and contents of container

Race In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.

4.

The primary efficacy parameter of the trial was overall survival, defined as the time from randomization to death from any cause.

Pharmacokinetics in Special Populations The population pharmacokinetics were analysed to evaluate the effects of demographic characteristics.

EU/ 1/ 97/ 046/ 016-020 EU/ 1/ 97/ 046/ 031 EU/ 1/ 97/ 046/ 034 EU/ 1/ 97/ 046/ 037

Package size

Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).

Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.

Slovenská republika GlaxoSmithKline Slovakia s. r. o.